Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'C536315', 'term': 'Pediatric ulcerative colitis'}, {'id': 'C536215', 'term': "Pediatric Crohn's disease"}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission', 'timeFrame': 'Week 52', 'description': 'Clinical Remission based on the MMS'}, {'measure': "Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission", 'timeFrame': 'Week 52', 'description': 'Clinical Remission based on the PCDAI'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with UC in MMS Clinical Response', 'timeFrame': 'Week 52', 'description': 'Clinical Response based on the MMS'}, {'measure': 'Percentage of Participants with CD in PCDAI Clinical Response', 'timeFrame': 'Week 52', 'description': 'Clinical Response based on the PCDAI'}, {'measure': 'Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response', 'timeFrame': 'Week 52', 'description': 'Clinical Response based on the PUCAI'}, {'measure': 'Percentage of Participants with UC in PUCAI Clinical Remission', 'timeFrame': 'Week 52', 'description': 'Clinical Response based on the PUCAI'}, {'measure': 'Percentage of Participants with UC in Endoscopic Remission', 'timeFrame': 'Week 52', 'description': 'Endoscopic Remission based on the Endoscopic Subscore (ES)'}, {'measure': 'Percentage of Participants with CD in Endoscopic Remission', 'timeFrame': 'Week 52', 'description': "Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)"}, {'measure': 'Percentage of Participants with UC in Endoscopic Response', 'timeFrame': 'Week 52', 'description': 'Endoscopic Response in Participants based on the ES'}, {'measure': 'Percentage of Participants with CD in Endoscopic Response', 'timeFrame': 'Week 52', 'description': 'Endoscopic Response based on the SES-CD'}, {'measure': 'Percentage of Participants with UC in having Endoscopic Subscore = 0', 'timeFrame': 'Week 52', 'description': 'Endoscopic Remission when ES = 0'}, {'measure': 'Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission', 'timeFrame': 'Week 52', 'description': 'Histologic remission based on histology scoring and endoscopic remission based on endoscopy score'}, {'measure': 'Percentage of Participants with CD Achieving Histologic Remission', 'timeFrame': 'Week 52', 'description': 'Histologic remission based on histology scoring'}, {'measure': 'Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery', 'timeFrame': 'Week 52', 'description': 'Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery'}, {'measure': 'Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery', 'timeFrame': 'Week 52', 'description': "Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)"}, {'measure': 'Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids', 'timeFrame': 'Week 0 to Week 52'}, {'measure': 'Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response', 'timeFrame': 'Week 52'}, {'measure': 'Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)', 'timeFrame': 'Baseline, Week 0 to Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Ulcerative Colitis', "Pediatric Crohn's Disease", 'Pediatric UC', 'Pediatric CD'], 'conditions': ['Ulcerative Colitis', 'Ulcerative Colitis Chronic', 'Inflammatory Bowel Diseases', "Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/6Fqthjwf4KUkJi8EyTQv5A', 'label': "A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)"}]}, 'descriptionModule': {'briefSummary': "The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants from originating studies (I6T-MC-AMBA \\[NCT05784246\\], I6T-MC-AMBU \\[NCT04004611\\], I6T-MC-AMAM \\[NCT03926130\\]) , I6T-MC-AMAY \\[NCT05509777\\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab\n* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.\n* Female participants must agree to contraception requirements.\n\nExclusion Criteria:\n\n* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.\n* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.\n* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.\n* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.\n* Participants must not have adenomatous polyps that have not been removed.\n* Participants must not be pregnant or breastfeeding."}, 'identificationModule': {'nctId': 'NCT04844606', 'acronym': 'SHINE-ON', 'briefTitle': "A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': "A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease", 'orgStudyIdInfo': {'id': '16633'}, 'secondaryIdInfos': [{'id': 'I6T-MC-AMAZ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2020-005311-49', 'type': 'EUDRACT_NUMBER'}, {'id': 'ISA-1 UC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'ISA-2 CD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'ISA-3 UC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'ISA-4 CD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 1 for UC', 'description': "Dose 1 of Mirikizumab is administered subcutaneously (SC)\n\nDosing is based on the participant's weight.", 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 2 for UC', 'description': "Dose 2 of Mirikizumab is administered SC\n\nDosing is based on the participant's weight.", 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 3 for UC', 'description': "Dose 3 of Mirikizumab is administered SC\n\nDosing is based on the participant's weight.", 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 4 for CD', 'description': "Dose 4 of Mirikizumab is administered SC\n\nDosing is based on the participant's weight.", 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 5 for CD', 'description': "Dose 5 of Mirikizumab is administered SC\n\nDosing is based on the participant's weight.", 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 6 for CD', 'description': "Dose 6 of Mirikizumab is administered SC\n\nDosing is based on the participant's weight.", 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Mirikizumab Dose 7 for UC or CD', 'description': 'Intravenous (IV) rescue dosing, if response is lost.', 'interventionNames': ['Drug: Mirikizumab']}], 'interventions': [{'name': 'Mirikizumab', 'type': 'DRUG', 'otherNames': ['LY3074828'], 'description': 'Administered SC', 'armGroupLabels': ['Mirikizumab Dose 1 for UC', 'Mirikizumab Dose 2 for UC', 'Mirikizumab Dose 3 for UC', 'Mirikizumab Dose 4 for CD', 'Mirikizumab Dose 5 for CD', 'Mirikizumab Dose 6 for CD']}, {'name': 'Mirikizumab', 'type': 'DRUG', 'otherNames': ['LY3074828'], 'description': 'Administered IV', 'armGroupLabels': ['Mirikizumab Dose 7 for UC or CD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sofia Verstraete', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSF Medical Center at Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Hyams', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'subra kugathasan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffery Lewis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Center for Digestive Health Care, LLC", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '617-355-6058'}, {'name': 'Athos Bousvaros', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jess Kaplan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '212-241-5415'}, {'name': 'David Dunkin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 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'lon': 8.28008}}, {'zip': '80337', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'role': 'CONTACT', 'phone': '004989440057931'}, {'name': 'Tobias Schwerd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr. von Haunersches Kinderspital', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '3109601', 'city': 'Haifa', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'role': 'CONTACT', 'phone': '972-4-7774381'}, {'name': 'Ramit Magen Rimon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '9013102', 'city': 'Jerusalem', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'role': 'CONTACT', 'phone': '+97226666482'}, {'name': 'Dan Turner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '9112001', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'role': 'CONTACT', 'phone': '+97226778718'}, {'name': 'Zev Davidovics', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '49202', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'role': 'CONTACT', 'phone': '972039253674'}, {'name': 'Dror Shouval', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '70300', 'city': 'Ẕerifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'role': 'CONTACT', 'phone': '972-8-934-9793'}, {'name': 'EFRAT BROIDE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yitzhak Shamir Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '24127', 'city': 'Bergamo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'phone': '0352673856'}, {'name': 'Naire 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Buzzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00161', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'phone': '0039 0649979330'}, {'name': 'Salvatore Oliva', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00165', 'city': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'phone': '0039 06 68592243'}, {'name': 'Fiammetta Bracci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Pediatrico Bambino Gesù IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '113-8519', 'city': 'Bunkyō', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'phone': '81120023812'}, {'name': 'Masakazu Nagahori', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Science Tokyo Hospital', 'geoPoint': {'lat': 35.37517, 'lon': 139.92991}}, {'zip': '113-8431', 'city': 'Bunkyō City', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'phone': '81120023812'}, {'name': 'Takahiro Kudo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '273-0011', 'city': 'Kashiwa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'phone': '81120023812'}, {'name': 'Ken Takeuchi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tsujinaka Hospital - Kashiwanoha', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Lissy De Ridder', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '1478', 'city': 'Lørenskog', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Christopher Inchley', 'role': 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'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Monika Meglicka', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Network Spółka z o.o. 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