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-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-10
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
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 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 plus 5 half-lives of the study (3 days) or 3 days post-treatment completion. In addition, male subjects must be willing to refrain from sperm donation during this time.
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