Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT03800420
Status:
TERMINATED
Last Update Posted:
2022-03-21
First Post:
2019-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials.gov_inquiries@bridgebiorx.com', 'phone': '+82-31-8092-3280', 'title': 'Clinical Trials_inquiries', 'organization': 'Clinical Trials_inquiries'}, 'certainAgreement': {'otherDetails': 'The Institution and Investigator shall not publish the results of this study without the prior written consent of sponsor. As used herein, the term "publish" shall include oral presentations, written abstracts, written manuscripts, etc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.\n\nNote 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.', 'eventGroups': [{'id': 'EG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal tract mucosal pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Faecal calprotectin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stool analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Mayo Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S First and Then Placebo', 'description': 'Total 16 weeks\n\nFirst 12 weeks, BBT-401-1S, Oral capsule, QD. Followed by 4 weeks Placebo, Oral capsule, QD.'}, {'id': 'OG001', 'title': 'Placebo First and Then BBT-401-1S', 'description': 'Total 16 weeks First Placebo, 8 weeks Oral capsule, QD Followed by 8 weeks BBT-401-1S, Oral capsule, QD'}], 'timeFrame': 'Week 8', 'description': 'The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Partial Mayo Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'timeFrame': 'Week 8', 'description': 'The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Histologic Assessment of Endoscopic Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'timeFrame': 'Week 8', 'description': 'Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'timeFrame': 'Week 8', 'description': 'The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}, {'type': 'SECONDARY', 'title': 'Number and Severity of TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'classes': [{'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal tract mucosal pigmentation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemorrhoids', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Melaena', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Onychomycosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Condition aggravated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 weeks after the last dose', 'description': 'Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of BBT- 401-1S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Samples were below the LLOQ', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Samples were below the LLOQ', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Week 4, Week 8', 'description': 'Analysis of Plasma Pharmacokinetics for BBT- 401 -1S', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All samples were below LLOQ and therefore plasma concentrations could not be calculated, (Plasma PK samples of one active patient were not collected.)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Concentration of Serum CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'timeFrame': 'Week 8', 'description': 'Widely used serum indicator of inflammation in Ulcerative Colitis(UC).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Concentration of Fecal Calprotectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'timeFrame': 'Week 8', 'description': 'Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Concentration of Fecal Lactoferrin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'timeFrame': 'Week 8', 'description': 'A stool (fecal) test that is used to detect inflammation in the intestines.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure due to early termination of study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD\n\nBBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, Oral capsule, QD\n\nPlacebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Mixed (White/Black)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'subjects who were randomized'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-19', 'size': 538401, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-02T02:59', 'hasProtocol': True}, {'date': '2020-07-22', 'size': 8272575, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-02T03:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2019-01-07', 'resultsFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-23', 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Mayo Score', 'timeFrame': 'Week 8', 'description': 'The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Partial Mayo Score', 'timeFrame': 'Week 8', 'description': 'The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.'}, {'measure': 'Change From Baseline in Histologic Assessment of Endoscopic Biopsy', 'timeFrame': 'Week 8', 'description': 'Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).'}, {'measure': 'Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)', 'timeFrame': 'Week 8', 'description': 'The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.'}, {'measure': 'Number and Severity of TEAEs', 'timeFrame': 'up to 8 weeks after the last dose', 'description': 'Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.'}, {'measure': 'Plasma Concentration of BBT- 401-1S', 'timeFrame': 'Day 1, Week 4, Week 8', 'description': 'Analysis of Plasma Pharmacokinetics for BBT- 401 -1S'}, {'measure': 'Change From Baseline in Concentration of Serum CRP', 'timeFrame': 'Week 8', 'description': 'Widely used serum indicator of inflammation in Ulcerative Colitis(UC).'}, {'measure': 'Change From Baseline in Concentration of Fecal Calprotectin', 'timeFrame': 'Week 8', 'description': 'Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).'}, {'measure': 'Change From Baseline in Concentration of Fecal Lactoferrin', 'timeFrame': 'Week 8', 'description': 'A stool (fecal) test that is used to detect inflammation in the intestines.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pellino-1'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.\n\nThis study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (ICF)\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged \\>=18 years\n* Diagnosed with active UC for at least 3 months prior to screening\n* Total Mayo score \\>=5 and Endoscopic sub-score \\>=1\n* Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks, and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks)\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the last dose\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose\n\nExclusion Criteria:\n\n* Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.\n* Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.\n* Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon\n* Previous extensive colonic resection (subtotal or total colectomy)\n* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine\n* Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization\n* Active infection with the HIV or Hepatitis B or C viruses\n* Clinically significant active extra-intestinal infection (e.g., pneumonia, pyelonephritis)\n* Clinically significant abnormal vital signs, physical examination or 12-lead electrocardiogram (ECG) at screening or baseline\n* Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin and alkaline phosphatase) \\> 2X the upper limit of normal (ULN) at screening\n* Other clinically significant abnormal laboratory results at screening in the investigator's opinion\n* History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study\n* Pregnancy or lactation\n* Treatment with another investigational drug or other intervention within 30 days prior to screening"}, 'identificationModule': {'nctId': 'NCT03800420', 'briefTitle': 'Efficacy and Safety of BBT-401-1S in Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bridge Biotherapeutics, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'BBT401-UC-US02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BBT-401-1S', 'description': 'BBT-401-1S, Oral capsule, QD', 'interventionNames': ['Drug: BBT-401-1S first and then Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, Oral capsule, QD', 'interventionNames': ['Drug: Placebo first and then BBT-401-1S']}], 'interventions': [{'name': 'BBT-401-1S first and then Placebo', 'type': 'DRUG', 'description': 'Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.', 'armGroupLabels': ['BBT-401-1S']}, {'name': 'Placebo first and then BBT-401-1S', 'type': 'DRUG', 'description': 'Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Site 03', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Site 01', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 11', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33029', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 12', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site 04', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 10', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '28112', 'city': 'Monroe', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site 02', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site 08', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 05', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 13', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 09', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bridge Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KCRN Research, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}