An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT03252587
• Date of registration: 15/08/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
• Scientific title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: September 21, 2017
• Target sample size: 363
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03252587
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Taiwan, Ukraine, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Systemic lupus erythematosus (SLE) disease diagnosed = 24 weeks before the screening
visit

- Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification
criteria for SLE

- One of the following: elevated antinuclear antibodies (ANA) = 1:80 or positive anti-
double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate
results) or positive anti-Smith (anti-Sm) as determined by the central laboratory

- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score = 6
points and clinical SLEDAI-2K score = 4 points with joint involvement and/or rash
[score must be confirmed by Central Review Services (CRS)]

- Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

- Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus
nephritis

- SLE overlap syndromes such as scleroderma and mixed connective tissue disease

- Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)

- History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: BMS-986165

Other: Placebo

Primary Outcome(s)

Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [Time Frame: At Week 32]

Secondary Outcome(s)

Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Time Frame: Up to 52 weeks]

Incidence of clinically significant changes in vital signs: Heart rate [Time Frame: Up to 56 weeks]

Assess the effect of BMS-986165 on measures of global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (ie, high versus low IRG signature) [Time Frame: Up to 52 weeks]

Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [Time Frame: At Week 48]

Change in mean and median interferon-regulated gene (IRG) expression levels [Time Frame: Up to 52 weeks]

Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Time Frame: Up to 56 weeks]

Incidence of clinically significant changes in vital signs: Blood pressure [Time Frame: Up to 56 weeks]

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Time Frame: Up to 56 weeks]

Incidence of clinically significant changes in vital signs: Respiratory rate [Time Frame: Up to 56 weeks]

Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [Time Frame: At Week 48]

Trough observed plasma concentration (Ctrough) [Time Frame: Up to 48 weeks]

Incidence of adverse events (AEs) [Time Frame: Up to 52 weeks]

Incidence of serious adverse events (SAEs) [Time Frame: Up to 56 weeks]

Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score = 10 at baseline achieving a CLASI response, defined as a decrease of = 50% from baseline CLASI activity score [Time Frame: At Week 48]

Time of maximum observed plasma concentration (Tmax) [Time Frame: Up to 48 weeks]

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Time Frame: Up to 56 weeks]

Incidence of clinically significant changes in vital signs: Body temperature [Time Frame: Up to 56 weeks]

Maximum observed plasma concentration (Cmax) [Time Frame: Up to 48 weeks]

Number of participants who achieve Lupus Low Disease Activity State (LLDAS) [Time Frame: At Week 48]

Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA) levels [Time Frame: Up to 52 weeks]

Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [Time Frame: At Week 48]

Secondary ID(s)

2017-001203-79

IM011-021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors