Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT03524092
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2018-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Croatia', 'Saudi Arabia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708407', 'term': 'mirikizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up To 40 Weeks', 'description': 'All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 57, 'seriousNumAtRisk': 192, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 90, 'seriousNumAtRisk': 389, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Maintenance Period: PBO IR - PBO SC', 'description': 'Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 37, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV', 'description': 'Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 13, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Extended Induction: Induction Nonresponders - 300mg Miri IV', 'description': 'Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.', 'otherNumAtRisk': 461, 'deathsNumAtRisk': 461, 'otherNumAffected': 44, 'seriousNumAtRisk': 461, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG005', 'title': 'Open Label Maintenance: Delayed Responders - 200 mg Miri SC', 'description': 'Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 54, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 18, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Maculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bacillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 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'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colectomy total', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Retinopexy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Clinical Remission at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '31.5'}, {'value': '49.9', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '55.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.2', 'ciLowerLimit': '15.2', 'ciUpperLimit': '31.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': "Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability).\n\nStool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Endoscopic Remission at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '35.7'}, {'value': '58.6', 'groupId': 'OG001', 'lowerLimit': '53.6', 'upperLimit': '63.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.5', 'ciLowerLimit': '20.2', 'ciUpperLimit': '36.8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Histologic Remission at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '30.9'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '43.4', 'upperLimit': '53.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '14.5', 'ciUpperLimit': '30.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Symptomatic Remission at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '46.8'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '66.3', 'upperLimit': '75.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.2', 'ciLowerLimit': '21.9', 'ciUpperLimit': '38.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': "Symptomatic remission at week 40 is defined as a Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline.\n\nStool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).\n\nRectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Endoscopic Response at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '33.6', 'upperLimit': '48.0'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '77.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '22.4', 'ciUpperLimit': '39.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Clinical Response at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '56.5'}, {'value': '80.3', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '84.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.6', 'ciLowerLimit': '22.3', 'ciUpperLimit': '38.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': "Clinical response at week 40 is defined as a decrease in the 9-point modified Mayo score (MMS) \\[rectal bleeding, stool frequency and the endoscopic findings\\] inclusive of \\>= 2 points and \\>=30% from baseline with either a decrease of rectal bleeding subscore of \\>=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.51', 'spread': '2.767', 'groupId': 'OG000'}, {'value': '49.75', 'spread': '2.102', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.24', 'ciLowerLimit': '19.16', 'ciUpperLimit': '31.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.094', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with modified baseline observation carried forward (mBOCF).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Induction Baseline, Week 40', 'description': 'The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects\' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline IBDQ measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 40 in Fecal Calprotectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1155.82', 'spread': '221.394', 'groupId': 'OG000'}, {'value': '-1995.47', 'spread': '172.443', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-839.64', 'ciLowerLimit': '-1323.08', 'ciUpperLimit': '-356.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '245.990', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA with modified baseline observation carried forward (mBOCF).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Induction Baseline, Week 40', 'description': 'Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12.', 'unitOfMeasure': 'milligram per kilogram (mg/kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline fecal calprotectin measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.74', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-3.80', 'spread': '0.139', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.228', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Induction Baseline, Week 40', 'description': 'The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Hospitalized for Ulcerative Colitis (UC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'OG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with \\>=24 hours stay were recorded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Clearance of Mirikizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '200 Milligram (mg) Miri SC', 'description': 'Participants who received 200 mg mirikizumab SC every Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0487', 'spread': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose: Weeks 0, 4, 12, 24 and 40', 'description': 'Clearance of mirikizumab was evaluated.', 'unitOfMeasure': 'Liters per Hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug subcutaneously (both induction responders and nonresponders) and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC)', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'FG001', 'title': 'Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}, {'id': 'FG002', 'title': 'Maintenance Period: PBO IR - PBO SC', 'description': 'Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}, {'id': 'FG003', 'title': 'Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV', 'description': 'Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.'}, {'id': 'FG004', 'title': 'Extended Induction: Induction Nonresponders - 300mg Miri IV', 'description': 'Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.'}, {'id': 'FG005', 'title': 'Open Label Maintenance: Delayed Responders - 200 mg Miri SC', 'description': 'Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).'}], 'periods': [{'title': 'Blinded Maintenance Period (Wk 0-40)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '389'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '389'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '347'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Loss of Response Rescue Period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Loss of Response Rescue Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants were assigned to this arm only after at least 12 weeks of blinded maintenance period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants were assigned to this arm only after at least 12 weeks of blinded maintenance period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants were assigned to this arm only after at least 12 weeks of blinded maintenance period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Included only participants who experienced loss of response and were eligible for loss of response rescue induction.', 'groupId': 'FG003', 'numSubjects': '90'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '81'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extended Induction (Wk 0-12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants were assigned to this arm only during loss of response rescue period.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Included only participants who entered open label extended induction period.', 'groupId': 'FG004', 'numSubjects': '461'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '271'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '190'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Covid-19 related study disruption', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '162'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of capacity due to lack of staff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open Label Maintenance Period (Wk 12-40)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants were assigned to this arm only during open label extended induction period.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Included only participants who entered open label maintenance period.', 'groupId': 'FG005', 'numSubjects': '271'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '256'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Covid-19 related study disruption', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 1177 Participants enrolled in the study of which 716 participants entered to Blinded Maintenance Period as Induction Responder (IR) and 461 participants entered into open label extended Induction period as Induction Nonresponders.', 'preAssignmentDetails': 'This study was designed to evaluate the safety and efficacy of mirikizumab (miri) in achieving remission at Week (Wk) 40 in participants who completed the 12-week induction study I6T-MC-AMAN (NCT03518086) as clinical responders to mirikizumab. Results for maximum extended enrollment (ME2) participants will be posted after the study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '461', 'groupId': 'BG003'}, {'value': '1177', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Maintenance Period: Miri IR - PBO SC', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.'}, {'id': 'BG001', 'title': 'Maintenance Period: Miri IR - 200 mg Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}, {'id': 'BG002', 'title': 'Maintenance Period: PBO IR - PBO SC', 'description': 'Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.'}, {'id': 'BG003', 'title': 'Extended Induction: Induction Nonresponders - 300mg Miri IV', 'description': 'Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.20', 'spread': '12.88', 'groupId': 'BG000'}, {'value': '43.30', 'spread': '14.13', 'groupId': 'BG001'}, {'value': '40.80', 'spread': '13.40', 'groupId': 'BG002'}, {'value': '43.40', 'spread': '13.86', 'groupId': 'BG003'}, {'value': '42.70', 'spread': '13.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '465', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '295', 'groupId': 'BG003'}, {'value': '712', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '344', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '397', 'groupId': 'BG003'}, {'value': '1038', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity data collected only for United States (US) participants.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '259', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}, {'value': '884', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 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'groupId': 'BG004'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-12', 'size': 2450124, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-25T03:59', 'hasProtocol': True}, {'date': '2021-10-01', 'size': 6613102, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-25T04:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2018-05-10', 'resultsFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2018-05-10', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-11-02', 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in Clinical Remission at Week 40', 'timeFrame': 'Week 40', 'description': "Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability).\n\nStool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in Endoscopic Remission at Week 40', 'timeFrame': 'Week 40', 'description': 'Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).'}, {'measure': 'Percentage of Participants With Histologic Remission at Week 40', 'timeFrame': 'Week 40', 'description': 'Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).'}, {'measure': 'Percentage of Participants in Symptomatic Remission at Week 40', 'timeFrame': 'Week 40', 'description': "Symptomatic remission at week 40 is defined as a Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline.\n\nStool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).\n\nRectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed)."}, {'measure': 'Percentage of Participants in Endoscopic Response at Week 40', 'timeFrame': 'Week 40', 'description': 'Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.'}, {'measure': 'Percentage of Participants in Clinical Response at Week 40', 'timeFrame': 'Week 40', 'description': "Clinical response at week 40 is defined as a decrease in the 9-point modified Mayo score (MMS) \\[rectal bleeding, stool frequency and the endoscopic findings\\] inclusive of \\>= 2 points and \\>=30% from baseline with either a decrease of rectal bleeding subscore of \\>=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration)."}, {'measure': 'Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score', 'timeFrame': 'Induction Baseline, Week 40', 'description': 'The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects\' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).'}, {'measure': 'Change From Baseline to Week 40 in Fecal Calprotectin', 'timeFrame': 'Induction Baseline, Week 40', 'description': 'Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12.'}, {'measure': 'Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)', 'timeFrame': 'Induction Baseline, Week 40', 'description': 'The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).'}, {'measure': 'Percentage of Participants Hospitalized for Ulcerative Colitis (UC)', 'timeFrame': 'Week 40', 'description': 'Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with \\>=24 hours stay were recorded.'}, {'measure': 'Pharmacokinetics (PK): Clearance of Mirikizumab', 'timeFrame': 'Predose: Weeks 0, 4, 12, 24 and 40', 'description': 'Clearance of mirikizumab was evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interleukin-23 (IL-23)', 'IL-23p19', 'Inflammatory Bowel Disease'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '40591171', 'type': 'DERIVED', 'citation': 'Clemow DB, Dubinsky MC, Baygani SK, Sands BE, Keohane A, Danese S, Schreiber S, Walsh AJ, Hibi T, Gibble TH, Moses RE, Travis SPL. Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab. J Patient Rep Outcomes. 2025 Jul 1;9(1):75. doi: 10.1186/s41687-025-00906-0.'}, {'pmid': '40589947', 'type': 'DERIVED', 'citation': 'Panaccione R, Chan-Diehl F, Baygani S, Fisher DA, Moses RE, Siegmund B, Walsh A, Kobayashi T, Dulai PS, Travis S. Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis. Crohns Colitis 360. 2025 Jun 14;7(2):otaf043. doi: 10.1093/crocol/otaf043. eCollection 2025 Apr.'}, {'pmid': '40071779', 'type': 'DERIVED', 'citation': 'Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.'}, {'pmid': '39448057', 'type': 'DERIVED', 'citation': "Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253."}, {'pmid': '38869019', 'type': 'DERIVED', 'citation': 'Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, Moses R, Maier S, Hunter Gibble T, Morris N, Milch C, Abreu MT. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme. J Crohns Colitis. 2024 Nov 4;18(11):1845-1856. doi: 10.1093/ecco-jcc/jjae088.'}, {'pmid': '38313767', 'type': 'DERIVED', 'citation': 'Long MD, Schreiber S, Hibi T, Gibble TH, Fisher DA, Park G, Moses RE, Higgins PDR, Lindsay JO, Lee SD, Escobar R, Jairath V. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies. Crohns Colitis 360. 2024 Jan 6;6(1):otae001. doi: 10.1093/crocol/otae001. eCollection 2024 Jan.'}, {'pmid': '38034882', 'type': 'DERIVED', 'citation': 'Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A. Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. Crohns Colitis 360. 2023 Nov 7;5(4):otad070. doi: 10.1093/crocol/otad070. eCollection 2023 Oct.'}, {'pmid': '37610533', 'type': 'DERIVED', 'citation': 'Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.'}, {'pmid': '37379135', 'type': 'DERIVED', 'citation': "D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940."}, {'pmid': '37057827', 'type': 'DERIVED', 'citation': 'Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis. 2023 Oct 20;17(9):1457-1470. doi: 10.1093/ecco-jcc/jjad050.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/6R2qUhQWcgImGasYaaGmYq', 'label': 'A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.\n* Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.\n* If female, must meet the contraception requirements.\n\nExclusion Criteria:\n\n* Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).\n* Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.\n* Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).\n* Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).\n* Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).\n* Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug."}, 'identificationModule': {'nctId': 'NCT03524092', 'acronym': 'LUCENT 2', 'briefTitle': 'A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)', 'orgStudyIdInfo': {'id': '16823'}, 'secondaryIdInfos': [{'id': 'I6T-MC-AMBG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2017-003238-96', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)', 'description': 'Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.', 'interventionNames': ['Drug: Placebo SC']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC', 'description': 'Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.', 'interventionNames': ['Drug: Mirikizumab SC']}, {'type': 'OTHER', 'label': 'Maintenance Period: PBO IR - PBO SC', 'description': 'Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.', 'interventionNames': ['Drug: Placebo SC']}, {'type': 'OTHER', 'label': 'Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV', 'description': 'Participants who received PBO SC or 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.', 'interventionNames': ['Drug: Mirikizumab IV']}, {'type': 'OTHER', 'label': 'Extended Induction: Induction Nonresponders - 300mg Miri IV', 'description': 'Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.', 'interventionNames': ['Drug: Mirikizumab IV']}, {'type': 'OTHER', 'label': 'Open Label Maintenance: Delayed Responders - 200 mg Miri SC', 'description': 'Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40.', 'interventionNames': ['Drug: Mirikizumab SC']}], 'interventions': [{'name': 'Mirikizumab SC', 'type': 'DRUG', 'otherNames': ['LY3074828'], 'description': 'Administered SC', 'armGroupLabels': ['Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC', 'Open Label Maintenance: Delayed Responders - 200 mg Miri SC']}, {'name': 'Mirikizumab IV', 'type': 'DRUG', 'otherNames': ['LY3074828'], 'description': 'Administered IV', 'armGroupLabels': ['Extended Induction: Induction Nonresponders - 300mg Miri IV', 'Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV']}, {'name': 'Placebo SC', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)', 'Maintenance Period: PBO IR - PBO SC']}]}, 'contactsLocationsModule': {'locations': 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