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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223712

Enrollment

360

Registered

2017-11-13

Start date

2018-08-08

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Systemic Lupus Erythematosus

Interventions

investigational material(s) Generic name etc : BMS-986165 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE and diagnosed not less than 24 weeks before the screening visit One of the following: antinuclear antibody (ANA) not less than 1:80 or positive anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score not less than 6 points and clinical SLEDAI-2K score not less than 4 points

Exclusion criteria

Exclusion criteria: Subjects with 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 ECG History of any significant drug allergy

Design outcomes

Primary

Measure	Time frame
safety Number of participants who meet response criteria for SLE Responder Index [SRI(4)] [ Time Frame: 32 weeks ]	—

Secondary

Measure	Time frame
efficacy Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [ Time Frame: At Week 48 ] Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: At Week 48 ] Number of participants who achieve Lupus Low Disease Activity State (LLDAS) [ Time Frame: At Week 48 ] Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score more than 10 at baseline achieving a CLASI response, defined as a decrease of more than 50% from baseline CLASI activity score [ Time Frame: At Week 48 ] Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: At Week 48 ] Distribution of participants experiencing serious adverse events (SAEs) (56 weeks) Distribution of participants experiencing adverse events (AEs) (52 weeks) Distribution of participants experiencing abnormalities in laboratory testing (56 weeks) Distribution of participants experiencing abnormalities in vital signs (56 weeks) Distribution of participants experiencing abnormalities in electrocardiograms (ECGs) (52 weeks) Maximum observed plasma concentration (Cmax) (48 weeks ) Time of maximum observed plasma concentration (Tmax) (48 weeks) Trough observed plasma concentration (Ctrough) (48 weeks ) Change in mean and median interferon-regulated gene (IRG) expression levels [ Time Frame: Up to 52 weeks ] Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA) levels [ Time Frame: Up to 52 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 ]	—

Measure

Time frame

efficacy Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [ Time Frame: At Week 48 ] Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: At Week 48 ] Number of participants who achieve Lupus Low Disease Activity State (LLDAS) [ Time Frame: At Week 48 ] Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score more than 10 at baseline achieving a CLASI response, defined as a decrease of more than 50% from baseline CLASI activity score [ Time Frame: At Week 48 ] Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: At Week 48 ] Distribution of participants experiencing serious adverse events (SAEs) (56 weeks) Distribution of participants experiencing adverse events (AEs) (52 weeks) Distribution of participants experiencing abnormalities in laboratory testing (56 weeks) Distribution of participants experiencing abnormalities in vital signs (56 weeks) Distribution of participants experiencing abnormalities in electrocardiograms (ECGs) (52 weeks) Maximum observed plasma concentration (Cmax) (48 weeks ) Time of maximum observed plasma concentration (Tmax) (48 weeks) Trough observed plasma concentration (Ctrough) (48 weeks ) Change in mean and median interferon-regulated gene (IRG) expression levels [ Time Frame: Up to 52 weeks ] Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA) levels [ Time Frame: Up to 52 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 ]

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026