Systemic Lupus Erythematosus MedDRA version: 21.1 Level: LLT Classification code 10042947 Term: Systemic lupus erythematosus synd System Organ Class: 100000004859
Conditions
Interventions
Product Name: BMS-986165
Product Code: BMS-986165
Pharmaceutical Form: Tablet
INN or Proposed INN: BMS-986165
CAS Number: 1609392-28-0
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent 2) Type of Subject and Target Disease Characteristics a) Completion of Study IM011021 through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee. 3) Reproductive Status a) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study drug. b) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period. c) WOCBP must agree to use correctly a highly effective or less than highly effective method(s) of contraception for the duration of treatment with study drug(s) BMS-986165 plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion (total of 33 days after last dose of study drug). WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in protocol APPENDIX 4. d) Male subjects who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with study treatment BMS-986165. e) Azoospermic males are exempt from contraceptive requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 306 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: 1) Medical History and Concurrent Diseases a) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason 2) Findings Related to Possible Tuberculosis (TB) Infection a) Evidence of active TB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE;Secondary Objective: Efficacy: To characterize the long-term maintenance of response of BMS-986165 in the treatment of subjects with SLE To characterize patient-reported outcomes in subjects with SLE on long-term BMS-986165 therapy Pharmacokinetic: To explore long-term pharmacokinetics of BMS-986165 Pharmacodynamic: To explore long-term pharmacodynamics of BMS-986165;Primary end point(s): Adverse events and serious adverse events, vital sign measurements, and laboratory parameters;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: CLASI response - 40-joint count for tender, swollen, and tender + swollen joints - SRI(4) response - BICLA response - PGA - Corticosteroid use (yes/no) - Corticosteroid dose =7.5 mg/day (yes/no) - Flare Analysis o Time to first flare o Number and frequency of flares o Flares leading to hospitalization - SDI total score - BILAG response - SLEDAI-2K score - LLDAS response - PROMIS Fatigue Short Form 7a score Pharmacokinetic: - Plasma concentrations of BMS-986165 Pharmacodynamic: - dsDNA, CRP, Complement levels, UPCR;Timepoint(s) of evaluation of this end point: Efficacy - Throughout the study Pharmacokinetics - at Weeks 0, 4, 8, 24, 48 and 96 Pharmacodynamics - at Weeks 0, 4, 8, 12, 36, 60, 84, 96, 108, 120, 134, 148, 162, 174 and 178 | — |
Countries
Argentina, Brazil, Canada, Colombia, Hungary, Japan, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed