2022-502444-13-00
已完成
2 期
A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 20
- 主要终点
- Adverse events and serious adverse events, vital sign measurements, and laboratory parameters
概览
简要总结
To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent
- •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.
- •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
- •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-
- •e) Azoospermic males are exempt from contraceptive requirements.
排除标准
- •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
- •Findings Related to Possible Tuberculosis (TB) Infection a) Evidence of active TB
结局指标
主要结局
Adverse events and serious adverse events, vital sign measurements, and laboratory parameters
Adverse events and serious adverse events, vital sign measurements, and laboratory parameters
次要结局
- LLDAS response
- PROMIS Fatigue Short Form 7a score
- Pharmacokinetic: - Plasma concentrations of BMS-986165
- Pharmacodynamic: - dsDNA, CRP, Complement levels, UPCR
- Corticosteroid dose ≤7.5 mg/day (yes/no)
- Efficacy: CLASI response
- 40-joint count for tender, swollen, and tender + swollen joints
- SRI(4) response
- BICLA response
- PGA
- Corticosteroid use (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
研究者
GCT-SU
Scientific
Bristol Myers Squibb International Corporation
研究点 (20)
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