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Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus
EU CTIS ID: 2022-502444-13-00
What this study is testing
To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Colombia
- United States
- Argentina
- Brazil
- Korea, Republic of
- Japan
- Canada
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Colombia; United States; Argentina; Brazil; Korea, Republic of and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.