Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03482635
Status:
COMPLETED
Last Update Posted:
2025-10-16
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Czechia', 'Denmark', 'Greece', 'Hungary', 'Netherlands', 'Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712973', 'term': 'spesolimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.\n\nInvestigators shall provide BI with a copy of any publication or presentation of review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to recruitment issues during phase II, the trial was prematurely ended according to a protocol defined option. Phase III was not conducted. The trial was completed as defined in the protocol.'}}, 'adverseEventsModule': {'timeFrame': 'From screening until end of study, up to 29 weeks.', 'description': 'Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 5, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 7, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 17, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With Clinical Remission at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.143'}, {'value': '0.042', 'groupId': 'OG001', 'lowerLimit': '0.007', 'upperLimit': '0.202'}, {'value': '0.087', 'groupId': 'OG002', 'lowerLimit': '0.024', 'upperLimit': '0.268'}, {'value': '0.071', 'groupId': 'OG003', 'lowerLimit': '0.020', 'upperLimit': '0.226'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.105', 'ciUpperLimit': '0.202', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.268', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.071', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '0.226', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 \\[if drop ≥1 from baseline\\] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12.\n\nProportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Clinical Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.217', 'groupId': 'OG000', 'lowerLimit': '0.097', 'upperLimit': '0.419'}, {'value': '0.167', 'groupId': 'OG001', 'lowerLimit': '0.067', 'upperLimit': '0.359'}, {'value': '0.261', 'groupId': 'OG002', 'lowerLimit': '0.125', 'upperLimit': '0.465'}, {'value': '0.250', 'groupId': 'OG003', 'lowerLimit': '0.127', 'upperLimit': '0.434'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.051', 'ciLowerLimit': '-0.276', 'ciUpperLimit': '0.176', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.199', 'ciUpperLimit': '0.280', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.033', 'ciLowerLimit': '-0.204', 'ciUpperLimit': '0.252', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Endoscopic Improvement at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.143'}, {'value': '0.083', 'groupId': 'OG001', 'lowerLimit': '0.023', 'upperLimit': '0.258'}, {'value': '0.087', 'groupId': 'OG002', 'lowerLimit': '0.024', 'upperLimit': '0.268'}, {'value': '0.071', 'groupId': 'OG003', 'lowerLimit': '0.020', 'upperLimit': '0.226'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '0.258', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.268', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.071', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '0.226', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\]. 95% CI for risk difference were calculated using the method of Newcombe.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.143'}, {'value': '0.083', 'groupId': 'OG001', 'lowerLimit': '0.023', 'upperLimit': '0.258'}, {'value': '0.043', 'groupId': 'OG002', 'lowerLimit': '0.008', 'upperLimit': '0.210'}, {'value': '0.036', 'groupId': 'OG003', 'lowerLimit': '0.006', 'upperLimit': '0.177'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '0.258', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\].', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.104', 'ciUpperLimit': '0.210', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\].', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.036', 'ciLowerLimit': '-0.110', 'ciUpperLimit': '0.177', 'estimateComment': 'Unadjusted absolute risk difference to placebo, \\[Treatment - Placebo\\].', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.'}, {'type': 'SECONDARY', 'title': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'OG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '35.0'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '34.5'}, {'value': '21.2', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '35.9'}, {'value': '20.8', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '35.4'}]}]}], 'analyses': [{'pValue': '0.9776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-21.6', 'ciUpperLimit': '21.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.7', 'groupDescription': 'Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8940', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '22.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.6', 'groupDescription': 'Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9241', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-20.0', 'ciUpperLimit': '22.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.6', 'groupDescription': 'Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at week 12.', 'description': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12.\n\nThe IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID).\n\nMean is adjusted mean.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Randomised Set (m-RS): The m-RS included all patients in the RS who had a baseline and at least 1 post-baseline measurement for the endpoint under consideration. Treatment assignment was randomised.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'FG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'FG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'FG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'comment': 'Completed trial medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawn by Principle Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Phase II/III randomized, placebo-controlled, double-blind trial to assess the safety and efficacy of spesolimab induction therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy. Phase III was not conducted, due to recruitment issues in Phase II.', 'preAssignmentDetails': 'Only subjects that met all the study inclusion and non of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'BG001', 'title': '300 mg Spesolimab (BI 655130) SD', 'description': 'A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'BG002', 'title': '450 mg Spesolimab (BI 655130) q4w', 'description': '450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'BG003', 'title': '1200 mg Spesolimab (BI 655130) q4w', 'description': '1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '15.3', 'groupId': 'BG002'}, {'value': '43.9', 'spread': '14.9', 'groupId': 'BG003'}, {'value': '42.5', 'spread': '14.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomised Set: The RS included all randomised patients. Treatment assignment was as randomised. It was the main analysis set for presentation of efficacy on binary endpoints.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-09', 'size': 1336190, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-18T06:02', 'hasProtocol': True}, {'date': '2020-03-02', 'size': 564708, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-18T03:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2018-03-15', 'resultsFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-05-18', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With Clinical Remission at Week 12', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 \\[if drop ≥1 from baseline\\] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12.\n\nProportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Clinical Response at Week 12', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson.'}, {'measure': 'Proportion of Patients With Endoscopic Improvement at Week 12', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.'}, {'measure': 'Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12', 'timeFrame': 'At week 12.', 'description': 'Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed.'}, {'measure': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12', 'timeFrame': 'At baseline and at week 12.', 'description': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12.\n\nThe IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID).\n\nMean is adjusted mean.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colitis, Ulcerative']}, 'referencesModule': {'references': [{'pmid': '39216969', 'type': 'DERIVED', 'citation': "Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available."}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are\n\n* to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)\n* to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)\n* To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 75 years, at date of signing informed consent, males or females\n* Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report\n* Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)\n* Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)\n* Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)\n* Further inclusion criteria apply\n\nExclusion Criteria:\n\n* Evidence of abdominal abscess at screening\n* Evidence of fulminant colitis or toxic megacolon at screening\n* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine\n* Further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03482635', 'briefTitle': 'BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy', 'orgStudyIdInfo': {'id': '1368-0005'}, 'secondaryIdInfos': [{'id': '2017-004230-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1- Placebo Group', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2- Small Dose Group', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3- Medium Dose Group', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 - High Dose Group', 'interventionNames': ['Drug: Spesolimab']}], 'interventions': [{'name': 'Spesolimab', 'type': 'DRUG', 'description': 'Solution for infusion', 'armGroupLabels': ['Group 2- Small Dose Group', 'Group 3- Medium Dose Group', 'Group 4 - High Dose Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for infusion', 'armGroupLabels': ['Group 1- Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Medical Research Center of Connecticut, LLC', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Gastroenterology, P.C.', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center-New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Digestive Disease Specialists Inc', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Southern Star Research Institute, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76092', 'city': 'Southlake', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Digestive Disease Consultants - Southlake', 'geoPoint': {'lat': 32.94124, 'lon': -97.13418}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'A-4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH - Barmherzige Schwestern', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH - Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba - Health Sciences Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital (LHSC)', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen, AöR', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen AöR', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '73730', 'city': 'Esslingen am Neckar', 'country': 'Germany', 'facility': 'Klinikum Esslingen GmbH', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '20089', 'city': 'Rozzano (MI)', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '285-8741', 'city': 'Chiba, Sakura', 'country': 'Japan', 'facility': 'Toho University Sakura Medical Center'}, {'zip': '004-0041', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Sapporo Tokushukai Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '065-0033', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Sapporo Higashi Tokushukai Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '663-8501', 'city': 'Hyogo, Nishinomiya', 'country': 'Japan', 'facility': 'Hyogo College of Medicine Hospital'}, {'zip': '892-0846', 'city': 'Kagoshima, Kagoshima', 'country': 'Japan', 'facility': 'Sameshima Hospital'}, {'zip': '247-0056', 'city': 'Kanagawa, Kamakura', 'country': 'Japan', 'facility': 'Ofuna Chuo Hospital'}, {'zip': '113-8519', 'city': 'Tokyo, Bunkyo-ku', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University'}, {'zip': '108-8642', 'city': 'Tokyo, Minato-ku', 'country': 'Japan', 'facility': 'Kitasato Institute Hospital'}, {'zip': '169-0073', 'city': 'Tokyo, Shinjuku', 'country': 'Japan', 'facility': 'Tokyo Yamate Medical Center'}, {'zip': '00-632', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Health Center of Mother, Child and Youth Sp.z o.o.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Central Clinical Hospital MSWiA, Internal Diseases, Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '664003', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '610027', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Kirov State Med.Univ. of MoH RF', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '123423', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Reg. Clin. Scientific Research Institute na Vladimiskiy', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '357502', 'city': 'Pyatigorsk', 'country': 'Russia', 'facility': 'The limited liability company "Clinic USI 4D"', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'zip': '194044', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '42415', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Politècnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'S75 2EP', 'city': 'Barnsley', 'country': 'United Kingdom', 'facility': 'Barnsley Hospital', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}, {'zip': 'DN2 5LT', 'city': 'Doncaster', 'country': 'United Kingdom', 'facility': 'Doncaster Royal Infirmary', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'L35 5DR', 'city': 'Prescot', 'country': 'United Kingdom', 'facility': 'Whiston Hospital', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}