Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT04978493
Status:
TERMINATED
Last Update Posted:
2025-09-04
First Post:
2021-07-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for 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 trial discontinuation, patients that were ongoing in the follow-up period could not receive ustekinumab for the full 36 weeks, so End of Study assessments were either performed earlier or were missing, as was the case for endoscopies. Consequently, more patients had missing 48-week data that necessitated imputation via Non-response imputation or Last observation carried forward than there would have been had the trial continued as planned, so 48-week data must be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration, until end of follow-up period, up to 48 weeks.', 'description': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Enthesopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.69', 'groupId': 'OG000', 'lowerLimit': '-3.75', 'upperLimit': '0.37'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-5.63', 'upperLimit': '-1.60'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '4.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.45', 'estimateComment': '(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)', 'groupDescription': 'The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Within 28 days before randomization (baseline) and 12 weeks after first drug administration.', 'description': 'Absolute change from baseline in Simple Endoscopic Score for Crohn\'s disease (SES-CD) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If a subject discontinued after 6 weeks and had an assessment during the Week 8 visit window, the change in SES-CD score at Week 8 was carried forward to the Week 12 time point and used. If there was no post-baseline endoscopic assessment, baseline value was carried forward.'}, {'type': 'SECONDARY', 'title': 'Percent Change in SES-CD From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.18', 'groupId': 'OG000', 'lowerLimit': '-30.30', 'upperLimit': '1.95'}, {'value': '-27.52', 'groupId': 'OG001', 'lowerLimit': '-43.30', 'upperLimit': '-11.73'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.34', 'ciLowerLimit': '-9.46', 'ciUpperLimit': '36.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.32', 'estimateComment': '(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)', 'groupDescription': 'The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Within 28 days before randomization (baseline) and 12 weeks after first drug administration.', 'description': 'Percent change in Simple Endoscopic Score for Crohn\'s disease (SES-CD) from baseline at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If a subject discontinued after 6 weeks and had an assessment during the Week 8 visit window, the change in SES-CD score at Week 8 was carried forward to the Week 12 time point and used. If there was no post-baseline endoscopic assessment, baseline value was carried forward.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '31.0'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '59.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.50', 'ciLowerLimit': '-48.42', 'ciUpperLimit': '-2.64', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days before randomization (baseline) and 12 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic response (defined as \\>50% Simple Endoscopic Score for Crohn\'s disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '35.9'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '34.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '-20.49', 'ciUpperLimit': '22.12', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days before randomization (baseline) and 48 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic response (defined as \\>50% Simple Endoscopic Score for Crohn\'s disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '20.2'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '25.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.83', 'ciLowerLimit': '-21.14', 'ciUpperLimit': '13.25', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn\'s disease (SES-CD) score of ≤2) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '25.8'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '25.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-17.67', 'ciUpperLimit': '18.78', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn\'s disease (SES-CD) score of ≤2) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '35.9'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '39.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-24.91', 'ciUpperLimit': '18.85', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after first drug administration.', 'description': 'Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) \\< 5 mg/L and faecal calprotectin (FCP) \\< 250 ug/g at Week 12 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '31.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '34.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.50', 'ciLowerLimit': '-23.86', 'ciUpperLimit': '17.34', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks after first drug administration.', 'description': 'Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) \\< 5 mg/L and faecal calprotectin (FCP) \\< 250 ug/g at Week 48 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': "Percentage of Patients With Clinical Remission at Week 12, Defined as a Crohn's Disease Activity Index (CDAI) Score of <150", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '57.3'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '37.1', 'upperLimit': '73.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.50', 'ciLowerLimit': '-42.32', 'ciUpperLimit': '8.89', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Data was collected for 7 days prior to 12 weeks after first drug administration.', 'description': "Percentage of patients with clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score of \\<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.", 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Clinical Remission at Week 48, Defined as a CDAI Score of <150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '40.5'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '39.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-21.53', 'ciUpperLimit': '23.41', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Data was collected for 7 days prior to 48 weeks after first drug administration.', 'description': 'Percentage of patients with clinical remission at Week 48, defined as a CDAI score of \\<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Clinical Response at Week 12, Defined by a CDAI Reduction From Baseline of at Least 100 Points, or a CDAI Score of <150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '27.9', 'upperLimit': '64.9'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '82.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Unadjusted risk difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.17', 'ciLowerLimit': '-45.42', 'ciUpperLimit': '5.19', 'estimateComment': 'BI 706321 and ustekinumab - Placebo and ustekinumab', 'groupDescription': 'Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days before randomization (baseline) and for 7 days prior to 12 weeks after first drug administration.', 'description': 'Percentage of patients with clinical response at Week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of \\<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter. If there were data at visits before and after one with a missing outcome, data was imputed as success only if both neighboring visits represented a success, independently of whether the before and after observations were selected for analysis based on the pre-defined time windows.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Treatment-emergent Adverse Event (TEAE) Through End of Treatment (EoT) and the REP Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'OG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until 16 days after last drug administration, up to 27 weeks.', 'description': 'Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the REP period is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'FG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'comment': 'Number of participants who completed the 12-weeks treatment with BI 706321 or placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'No reason available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "This was a Phase IIa, randomised, double-blind, placebo-controlled evaluation of male and female patients with Crohn's Disease (CD), using BI 706321 therapy in combination with a backbone ustekinumab induction regimen.", 'preAssignmentDetails': 'Subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) met all inclusion and no exclusion criteria. Subjects were not to be allocated to a treatment group if any entry criteria were violated. Subjects signed and dated an informed consent form according to local regulatory and legal requirements, and were informed that they were free to withdraw their consent at any time without penalty or prejudice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 706321 and Ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks."}, {'id': 'BG001', 'title': 'Placebo and Ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Simple Endoscopic Score for Crohn's disease (SES-CD)", 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '12.0', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '13.0', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least 1 dose of trial medication and have analyzable post-baseline data (observed or imputed) in at least 1 efficacy/biological/histological parameter.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-04', 'size': 1699759, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-14T10:25', 'hasProtocol': True}, {'date': '2024-08-02', 'size': 367808, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-03T06:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ustekinumab treatment is open-label for the Sponsor, patients and investigator/site staff.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'Company decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2021-07-26', 'resultsFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-15', 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12", 'timeFrame': 'Within 28 days before randomization (baseline) and 12 weeks after first drug administration.', 'description': 'Absolute change from baseline in Simple Endoscopic Score for Crohn\'s disease (SES-CD) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in SES-CD From Baseline at Week 12', 'timeFrame': 'Within 28 days before randomization (baseline) and 12 weeks after first drug administration.', 'description': 'Percent change in Simple Endoscopic Score for Crohn\'s disease (SES-CD) from baseline at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.'}, {'measure': 'Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 12', 'timeFrame': 'Within 28 days before randomization (baseline) and 12 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic response (defined as \\>50% Simple Endoscopic Score for Crohn\'s disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 48', 'timeFrame': 'Within 28 days before randomization (baseline) and 48 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic response (defined as \\>50% Simple Endoscopic Score for Crohn\'s disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 12', 'timeFrame': '12 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn\'s disease (SES-CD) score of ≤2) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 48', 'timeFrame': '48 weeks after first drug administration.', 'description': 'Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn\'s disease (SES-CD) score of ≤2) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 12', 'timeFrame': '12 weeks after first drug administration.', 'description': 'Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) \\< 5 mg/L and faecal calprotectin (FCP) \\< 250 ug/g at Week 12 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 48', 'timeFrame': '48 weeks after first drug administration.', 'description': 'Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) \\< 5 mg/L and faecal calprotectin (FCP) \\< 250 ug/g at Week 48 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': "Percentage of Patients With Clinical Remission at Week 12, Defined as a Crohn's Disease Activity Index (CDAI) Score of <150", 'timeFrame': 'Data was collected for 7 days prior to 12 weeks after first drug administration.', 'description': "Percentage of patients with clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score of \\<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method."}, {'measure': 'Percentage of Patients With Clinical Remission at Week 48, Defined as a CDAI Score of <150', 'timeFrame': 'Data was collected for 7 days prior to 48 weeks after first drug administration.', 'description': 'Percentage of patients with clinical remission at Week 48, defined as a CDAI score of \\<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Percentage of Patients With Clinical Response at Week 12, Defined by a CDAI Reduction From Baseline of at Least 100 Points, or a CDAI Score of <150', 'timeFrame': 'Within 28 days before randomization (baseline) and for 7 days prior to 12 weeks after first drug administration.', 'description': 'Percentage of patients with clinical response at Week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of \\<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.'}, {'measure': 'Number of Patients With Treatment-emergent Adverse Event (TEAE) Through End of Treatment (EoT) and the REP Period', 'timeFrame': 'From first drug administration until 16 days after last drug administration, up to 27 weeks.', 'description': 'Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the REP period is reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease.\n\nThe purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicine already used to treat Crohn's disease.\n\nParticipants are put into 2 groups randomly, which means by chance. One group gets BI 706321 and ustekinumab. The other group gets placebo and ustekinumab.\n\nParticipants take BI 706321 or placebo as tablets every day. Placebo tablets look like BI 706321 tablets but do not contain any medicine. Ustekinumab is given as an infusion into a vein once at the beginning of the study. After that, ustekinumab is given as an injection under the skin every 2 months. Participants take BI 706321 or placebo in combination with ustekinumab for 3 months. After that, participants receive only ustekinumab for another 9 months.\n\nParticipants are in the study for about 1 year. During this time, they visit the study site about 13 times. At 3 of the visits, doctors do a colonoscopy to examine the bowel. The results from the colonoscopies are compared between the 2 groups. The doctors also regularly check participants' health and take note of any unwanted effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Crohn Disease (CD) for at least 3 months prior to visit 1, as confirmed at any time in the past by endoscopy and/OR, radiology, and supported by histology.\n* Elevated C-reactive protein (≥ 5 mg/L) OR elevated fecal calprotectin (≥ 250 µg/g)\n* Symptomatic CD defined as Crohn's Disease Activity Index (CDAI) ≥150.\n* Presence of mucosal ulcers in at least one segment of the ileum or colon and a Simple Endoscopic Score for Crohn's disease (SES-CD) score ≥ 7 (for patients with isolated ileitis ≥4).\n* Patients who are experienced at least 1 tumor necrosis factor (TNF) antagonists at a dose approved for CD. Patients may have stopped TNF antagonist treatment due to primary or secondary non-responsiveness, intolerance, or for other reasons.\n* May be receiving a therapeutic dose of the following:\n\n * Oral 5-aminosalicylic acid (5-ASA) compounds must have been at a stable dose for at least 4 weeks prior to randomisation and must continue on this dose until week 12 and/or\n * Oral corticosteroids if indicated for treatment of CD must be at a prednisone equivalent dose of ≤ 20 mg/day, or ≤ 9 mg/day of budesonide, and have been at a stable dose for at least 2 weeks immediately prior to randomisation and must continue on this dose until week 12. and/or\n * Azathioprine (AZA), mercaptopurine (MP), or methotrexate (MTX), provided that dose has been stable for the 8 weeks immediately prior to randomisation and must continue on this dose until week 12.\n* Women of childbearing potential must be ready and able to use highly effective methods of birth control.\n* Further inclusion criteria apply\n\nExclusion Criteria:\n\n* Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomisation and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present based on investigator's judgement.\n* Have complications of CD such as strictures, stenosis, short bowel syndrome, or any other manifestation that might require surgery, or could preclude the use of SES-CD/CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 706321 (based on investigator's judgement).\n* Patient with an inflammatory bowel disease (IBD) diagnosis other than CD.\n* Have had any kind of bowel resection or diversion within 4 months or any other intra-abdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded.\n* Treatment with:\n\n * Any non-biologic medication for IBD (e.g.tacrolimus or mycophenolate mofetil, systemic corticosteroids), other than those allowed per inclusion criteria, within 30 days prior to randomisation\n * Any biologic treatment with a TNF-alpha antagonist (adalimumab, infliximab, golimumab, certolizumab pegol) or vedolizumab (or a biosimilar of these drugs) within 4 weeks prior to randomisation. (If drug level testing for previously used biologic treatment confirms no detectable drug level before randomisation, patient can be enrolled despite not having completed 4 week from last treatment.)\n * Any previous treatment with ustekinumab (or a biosimilar of this drug)\n * Any previous treatment with an investigational (or subsequently approved) non-biologic/biologic drug for CD (including but not limited to JAK inhibitors \\[e.g. upadacitinib\\], S1P modulators, IL-23 inhibitors \\[e.g. risankizumab\\], antiintegrins).\n * Any investigational drug for an indication other than CD during the course of the actual study and within 30 days or 5 half-lives (whichever is longer) prior to randomisation.\n * Any prior exposure to rituximab within 1 year prior to randomisation.\n* Positive stool examination for C difficile or other intestinal pathogens \\<30 days prior to randomization\n* Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed\n* Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. human immunodeficiency virus (HIV)), past organ or stem cell transplantation (with exception of a corneal transplant \\> 12 weeks prior to screening) or have ever received stem cell therapy (e.g., Prochymal). Prior treatment with a somatic cell therapy product (e.g., Alofisel) is not excluded, provided it was administered \\> 8 weeks prior to randomisation.\n* Live or attenuated vaccination within 4 weeks prior to randomisation.\n* Presence of clinically significant acute or chronic infections not otherwise listed, including viral hepatitis, COVID-19, or others based on investigator's judgement.\n* A marked baseline prolongation of QT/QTc interval (such as QTcF intervals that are greater than 450 ms for men, 470 ms for female) or any other relevant electrocardiogram (ECG) finding at screening. Both have to be confirmed by repeated ECG recording.\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04978493', 'briefTitle': "A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment", 'orgStudyIdInfo': {'id': '1425-0003'}, 'secondaryIdInfos': [{'id': '2020-004527-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 706321 and ustekinumab', 'description': "Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.", 'interventionNames': ['Drug: BI 706321', 'Drug: Ustekinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and ustekinumab', 'description': 'Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.\n\nA single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \\[kg\\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.', 'interventionNames': ['Drug: Ustekinumab', 'Drug: Placebo']}], 'interventions': [{'name': 'BI 706321', 'type': 'DRUG', 'description': 'One dose of 8 mg as tablets orally once per day in the morning', 'armGroupLabels': ['BI 706321 and ustekinumab']}, {'name': 'Ustekinumab', 'type': 'DRUG', 'description': 'A single intravenous infusion of 260 mg (body weight ≤55 kg), 390 mg (body weight 55-85 kg), or 520 mg (body weight \\>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg every 8 weeks.', 'armGroupLabels': ['BI 706321 and ustekinumab', 'Placebo and ustekinumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One dose of placebo matching BI 706321 as tablets orally once per day in the morning', 'armGroupLabels': ['Placebo and ustekinumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Research Associates Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Sweet Hope Research Specialty Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'I.H.S Health, LLC', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research Institute, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'Gastroenterology Associates of Western Michigan', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '64068', 'city': 'Liberty', 'state': 'Missouri', 'country': 'United States', 'facility': 'BVL Clinical Research', 'geoPoint': {'lat': 39.24611, 'lon': -94.41912}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Digestive Diseases', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, 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