ong-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Phase 1

Conditions: Systemic Lupus Erythematosus
MedDRA version: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2018-003471-35-PL

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 360

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

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
Main Objective: To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE;Secondary Objective: Efficacy:<br>To characterize the long-term maintenance of response of BMS-986165 in the treatment of subjects with SLE<br><br>To characterize patient-reported outcomes in subjects with SLE on long-term BMS-986165 therapy<br><br>Pharmacokinetic:<br>To explore long-term pharmacokinetics of BMS-986165<br><br>Pharmacodynamic:<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy:<br>CLASI response<br>- 40-joint count for tender, swollen, and tender + swollen joints<br>- SRI(4) response<br>- BICLA response<br>- PGA<br>- Corticosteroid use (yes/no)<br>- Corticosteroid dose =7.5 mg/day (yes/no)<br>- Flare Analysis<br> o Time to first flare<br> o Number and frequency of flares<br> o Flares leading to hospitalization<br>- SDI total score<br>- BILAG response<br>- SLEDAI-2K score<br>- LLDAS response<br>- PROMIS Fatigue Short Form 7a score<br><br>Pharmacokinetic:<br>- Plasma concentrations of BMS-986165<br><br>Pharmacodynamic:<br>- dsDNA, CRP, Complement levels, UPCR;Timepoint(s) of evaluation of this end point: Efficacy - Throughout the study<br>Pharmacokinetics - at Weeks 0, 4, 8, 24, 48 and 96<br>Pharmacodynamics - at Weeks 0, 4, 8, 12, 36, 60, 84, 96, 108, 120, 134, 148, 162, 174 and 178

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