A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004021-25-FR

Enrollment

600

Registered

2021-08-13

Start date

2021-10-13

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Systemic Lupus Erythematosus. MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: TLR7/8 Antagonist (2.5mg) Product Code: BMS-986256 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not available Current Sponsor code: BMS-986256 Other descriptive name: BMS-9862

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria = 12 weeks before the screening visit - Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody. - Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score = 6 points and clinical Hybrid SLEDAI score = 4 points with joint involvement and/or rash Other protocol-defined inclusion criteria apply. 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 582 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: - Active severe lupus nephritis (LN) as assessed by the investigator - Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI - Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE - Antiphospholipid Syndrome Other protocol-defined exclusion criteria apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity that is primarily driven by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), in participants with active SLE;Secondary Objective: - To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity with corticosteroids (CS) reduction and maintenance at a low level in participants with active SLE - To assess the efficacy of BMS-986256 versus placebo using an alternative composite measure of improvement in lupus activity that is primarily driven by the British Isles Lupus Assessment Group (BILAG), in participants in active SLE - To assess the efficacy of BMS-986256 versus placebo on measures of global and organ-specific clinical response in participants with active SLE - To assess the steroid-sparing effect of BMS-986256 versus placebo in participants with active SLE - To characterize patient-reported health status in participants with active SLE on BMS-986256 - To assess the safety and tolerability of BMS-986256 versus placebo in participants with active SLE;Primary end point(s): 1. Proportion of participants who achieve an SLE Responder Index 4 (SRI[4]) response at Week 48;Timepoint(s) of evaluation of this end point: 1. Up to 48 weeks	—

Measure

Time frame

Main Objective: - To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity that is primarily driven by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), in participants with active SLE;Secondary Objective: - To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity with corticosteroids (CS) reduction and maintenance at a low level in participants with active SLE - To assess the efficacy of BMS-986256 versus placebo using an alternative composite measure of improvement in lupus activity that is primarily driven by the British Isles Lupus Assessment Group (BILAG), in participants in active SLE - To assess the efficacy of BMS-986256 versus placebo on measures of global and organ-specific clinical response in participants with active SLE - To assess the steroid-sparing effect of BMS-986256 versus placebo in participants with active SLE - To characterize patient-reported health status in participants with active SLE on BMS-986256 - To assess the safety and tolerability of BMS-986256 versus placebo in participants with active SLE;Primary end point(s): 1. Proportion of participants who achieve an SLE Responder Index 4 (SRI[4]) response at Week 48;Timepoint(s) of evaluation of this end point: 1. Up to 48 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of participants that achieve an SRI(4) response with corticosteroids (CS) reduction and maintenance to = 7.5 mg per day at Week 48 2. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) at Week 24 and Week 48 3. Proportion of participants who achieve an SRI(4) response without CS reduction and maintenance to = 7.5 mg per day at Week 24 4. Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48 5. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score = 10 at baseline who achieve a decrease of = 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48 6. Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a = 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48 7. Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with = 2 swollen joints at baseline 8. Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with = 2 tender joints at baseline 9. Change from baseline in PGA score of disease activity at Week 24 and Week 48 10. Proportion of participants who achieve CS reduction or maintenance to = 7.5 mg per day at Week 48 11. Change in patient reported disease activity from baseline to Week 24 and Week 48 according to the (36-item Short Form Health Questionnaire) SF-36 12. Number of participants that experience Serious Adverse Events (SAEs) 13. Proportion of participants that experience SAEs 14. Number of participants that experience Adverse Events (AEs) 15. Proportion of participants that experience AEs 16. Number of participants that experience abnormalities or clinically important changes in c	—

Measure

Time frame

Secondary end point(s): 1. Proportion of participants that achieve an SRI(4) response with corticosteroids (CS) reduction and maintenance to = 7.5 mg per day at Week 48 2. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) at Week 24 and Week 48 3. Proportion of participants who achieve an SRI(4) response without CS reduction and maintenance to = 7.5 mg per day at Week 24 4. Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48 5. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score = 10 at baseline who achieve a decrease of = 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48 6. Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a = 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48 7. Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with = 2 swollen joints at baseline 8. Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with = 2 tender joints at baseline 9. Change from baseline in PGA score of disease activity at Week 24 and Week 48 10. Proportion of participants who achieve CS reduction or maintenance to = 7.5 mg per day at Week 48 11. Change in patient reported disease activity from baseline to Week 24 and Week 48 according to the (36-item Short Form Health Questionnaire) SF-36 12. Number of participants that experience Serious Adverse Events (SAEs) 13. Proportion of participants that experience SAEs 14. Number of participants that experience Adverse Events (AEs) 15. Proportion of participants that experience AEs 16. Number of participants that experience abnormalities or clinically important changes in c

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Countries

Argentina, Australia, Brazil, Chile, Colombia, France, Germany, Ireland, Japan, Mexico, Poland, Romania, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026