ong-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus ErythematosusMedDRA version: 21.1Level: LLTClassification code: 10025139Term: Lupus erythematosus systemic Class: 10028395Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2022-502444-13-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 261
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 posttreatment 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.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method