Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02763969
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628737', 'term': 'BMS-986202'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'D015738', 'term': 'Famotidine'}, {'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations', 'timeFrame': '4 weeks after the start of treatment'}, {'measure': 'Safety of a multiple oral dose of BMS-986202 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations', 'timeFrame': '4 weeks after the start of treatment'}, {'measure': 'Change from baseline in the psoriasis area', 'timeFrame': '4 weeks after the start of treatment'}, {'measure': 'Severity index (PASI) score', 'timeFrame': '4 weeks after the start of treatment'}], 'secondaryOutcomes': [{'measure': 'Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)', 'timeFrame': 'Approximately 3 months'}, {'measure': 'Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)', 'timeFrame': 'Approximately 3 months', 'description': 'The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)'}, {'measure': 'Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)', 'timeFrame': 'Approximately 3 months', 'description': 'The interval from the beginning of the Q wave and the end of the S wave (QRS interval)'}, {'measure': 'Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)', 'timeFrame': 'Approximately 3 months', 'description': 'The interval from the beginning of the Q wave to the end of the T wave (QT interval).\n\nThe QT interval corrected for heart rate (QTc interval)'}, {'measure': 'Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)', 'timeFrame': 'Approximately 3 months', 'description': 'Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E) based on number of incidence of adverse events(AEs), serious adverse events(SAEs), AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy Male and Female participants\n* 18 to 50 years of age (Parts A-D)\n* 18 to 70 years of age (Part E)\n* Diagnosed with plaque psoriasis (Part E)\n\nExclusion Criteria:\n\n* Participants that had recent infections\n* Participants with Low Blood Pressure\n* Participants with any heart related problems\n* Participants with cancer\n* Participants with any other major medical illness\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT02763969', 'briefTitle': 'Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986202 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986202 in Subjects With Moderate to Severe Psoriasis', 'orgStudyIdInfo': {'id': 'IM016-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Single Ascending Dose', 'description': 'BMS-986202 or Placebo specified dose on specified days', 'interventionNames': ['Drug: BMS-986202', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Multiple Ascending Dose', 'description': 'BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days', 'interventionNames': ['Drug: BMS-986202', 'Drug: Placebo', 'Drug: Interferon alpha-2a recombinant']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: Multiple Ascending Dose-Japanese descent', 'description': 'BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent', 'interventionNames': ['Drug: BMS-986202', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part D: Relative Bioavailability', 'description': 'BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days', 'interventionNames': ['Drug: BMS-986202', 'Drug: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'Part E: Proof of Mechanism', 'description': 'BMS-986202 or Placebo + Ustekinumab specified dose on specified days', 'interventionNames': ['Drug: BMS-986202', 'Drug: Placebo', 'Drug: Ustekinumab']}], 'interventions': [{'name': 'BMS-986202', 'type': 'DRUG', 'armGroupLabels': ['Part A: Single Ascending Dose', 'Part B: Multiple Ascending Dose', 'Part C: Multiple Ascending Dose-Japanese descent', 'Part D: Relative Bioavailability', 'Part E: Proof of Mechanism']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Part A: Single Ascending Dose', 'Part B: Multiple Ascending Dose', 'Part C: Multiple Ascending Dose-Japanese descent', 'Part E: Proof of Mechanism']}, {'name': 'Interferon alpha-2a recombinant', 'type': 'DRUG', 'armGroupLabels': ['Part B: Multiple Ascending Dose']}, {'name': 'Famotidine', 'type': 'DRUG', 'armGroupLabels': ['Part D: Relative Bioavailability']}, {'name': 'Ustekinumab', 'type': 'DRUG', 'armGroupLabels': ['Part E: Proof of Mechanism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}