Phase 2 N=363 Randomized Quadruple-blind Treatment

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

Systemic Lupus Erythematosus

Bottom Line

View on ClinicalTrials.gov: NCT03252587 ↗

Enrolled (actual)

363

Serious AEs

9.1%

Results posted

Sep 2022

Primary outcome: Primary: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32 — 31; 53; 46; 40 Participants — p=0.0006

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BMS-986165 (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32	31; 53; 46; 40	0.0006 sig
SECONDARY Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48	31; 52; 44; 42	0.0011 sig
SECONDARY Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response	23; 43; 33; 32	0.0012 sig
SECONDARY Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)	12; 33; 22; 23	0.0002 sig
SECONDARY Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10	4; 16; 14; 18	0.0006 sig
SECONDARY Change From Baseline in the 40-Joint Count	-11.2; -12.2; -11.7; -12.3; -8.3; -8.5	0.0131 sig
SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	79; 85; 81; 75; 11; 7	—
SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests	2; 5; 3; 2; 2; 1	—
SECONDARY Number of Participants With Abnormalities in Vital Signs	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Abnormalities in Electrocardiograms (ECGs)	9; 3; 6; 5; 1; 1	—
SECONDARY BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)	38.033; 76.400; 96.249; 6.358; 12.133; 11.748	—
SECONDARY BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)	2.0000; 2.0000; 2.0000; 4.0000; 4.0000; 3.7330	—
SECONDARY BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)	14.3737; 29.2909; 30.8135; 14.6095; 22.9170; 20.1182	—
SECONDARY Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels	-0.8130; -39.7478; -55.5691; -47.5561; 4.7381; -18.0641	—
SECONDARY Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32	-4.3993; -40.7944; -54.6988; -61.0515; -2.6555; -27.4897	—
SECONDARY Percent Change From Baseline in Complement Proteins C3 and C4 Levels	3.57; 5.33; 7.60; 14.74; 84.52; 3.57	—
SECONDARY Percent Change From Baseline in Complement (C3, C4) Levels at Week 32	-0.58; 5.78; 12.42; 10.84; -3.27; 12.32	—
SECONDARY Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels	276.26; 16.51; -31.79; -19.32	—
SECONDARY Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32	21.36; -15.24; -11.31; -24.17	—
SECONDARY Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status	10; 7; 11; 5; 21; 46	—

Summary

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03252587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.