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Clinical Trials List

Protocol NumberIM011074

NCT Number(ClinicalTrials.gov Identfier)NCT03920267

Completed

2019-06-01 - 2023-12-31

Phase II

Recruiting4

ICD-10M32.0

Drug-induced systemic lupus erythematosus

ICD-10M32.10

Systemic lupus erythematosus, organ or system involvement unspecified

ICD-10M32.11

Endocarditis in systemic lupus erythematosus

ICD-10M32.12

Pericarditis in systemic lupus erythematosus

ICD-10M32.13

Lung involvement in systemic lupus erythematosus

ICD-10M32.14

Glomerular disease in systemic lupus erythematosus

ICD-10M32.15

Tubulo-interstitial nephropathy in systemic lupus erythematosus

ICD-10M32.19

Other organ or system involvement in systemic lupus erythematosus

ICD-10M32.8

Other forms of systemic lupus erythematosus

ICD-10M32.9

Systemic lupus erythematosus, unspecified

ICD-9710.0

Systemic lupus erythematosus

A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus

Trial Applicant

BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
Sponsor

Bristol-Myers Squibb
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 魏正宗無

Chung Shan Medical University Hospital

Co-Principal Investigator

王世叡無
梁培英無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator KO-JEN LI 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ching Chang 無

Taipei Medical University Hospital

Co-Principal Investigator

Tzn-Min Lin 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳堃宏無

Cathay General Hospital

Co-Principal Investigator

全以祖無

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Systemic Lupus Erythematosus (SLE)

Objectives

 To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE  To characterize the long-term maintenance of response of BMS-986165 in the treatment of subjects with SLE  To characterize patient-reported outcomes in subjects with SLE on long-term BMS-986165 therapy  To explore long-term pharmacokinetics of BMS-986165  To explore long-term pharmacodynamics of BMS-986165

Test Drug

BMS-986165

Active Ingredient

BMS-986165

Dosage Form

tablet

Dosage

3/6/12

Endpoints

Primary Outcome Measures :

Number of participants with adverse events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
Number of participants with abnormal change from baseline in laboratory measurements over time [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
Number of participants with abnormal change from baseline in vital signs over time [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]

Inclution Criteria

1) Signed Written Informed Consent
a) Subjects must be willing to participate in the LTE study and must have the ability to sign
the informed consent form (ICF).
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 this 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.

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

The Estimated Number of Participants

Taiwan

11 participants
Global

360 participants