A Phase 2 Clinical Study to Assess the Safety and Efficacy of BMS-986165 in Participants with Active DLE and/or SCLE

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Participants with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000071-21-FR

Enrollment

150

Registered

2021-01-22

Start date

2021-03-18

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 Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) MedDRA version: 21.1 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: PT Classification code 10057903 Term: Subacute cutaneous lupus erythematosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: LLT Classification code 10013072 Term: Discoid lupus ery

Interventions

Product Name: BMS-986165 tablet 3mg Product Code: BMS-986165 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tyk2 inhibitor Current Sponsor code: BMS-986165 Other descriptive name: BMS986

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participants must have a diagnosis of DLE/SCLE - Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score = 8 - Participants must currently be receiving stable treatment regimen for CLE 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Participants with forms of drug-induced CLE and/or drug-induced SLE - Participants with other non-SLE driven inflammatory conditions that will significantly impact the assessment of CLE/SLE disease manifestations and activity

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of two doses of BMS-986165 (3 mg BID and 6 mg BID) compared with placebo on CLASI-A score at Week 16;Secondary Objective: To evaluate additional clinical measures of cutaneous disease manifestations with two doses of BMS-986165 (3 mg BID and 6 mg BID) compared with placebo at Week 16 To assess the safety and tolerability of two doses of BMS-986165 (3 mg BID and 6 mg BID) compared with placebo;Primary end point(s): Percentage change from baseline in CLASI activity (CLASIA) score ;Timepoint(s) of evaluation of this end point: at Week 16	—

Measure

Time frame

Main Objective: To evaluate the effect of two doses of BMS-986165 (3 mg BID and 6 mg BID) compared with placebo on CLASI-A score at Week 16;Secondary Objective: To evaluate additional clinical measures of cutaneous disease manifestations with two doses of BMS-986165 (3 mg BID and 6 mg BID) compared with placebo at Week 16 To assess the safety and tolerability of two doses of BMS-986165 (3 mg BID and 6 mg BID) compared with placebo;Primary end point(s): Percentage change from baseline in CLASI activity (CLASIA) score ;Timepoint(s) of evaluation of this end point: at Week 16

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Secondary

Measure	Time frame
Secondary end point(s): - Percentage of participants with an improvement of = 50% from baseline in the CLASI-A score (CLASI-50) - Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of = 4 points from baseline - Mean change from baseline in CLASI-A score - Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of “0” - Number and proportion of participants experiencing SAEs, AEs (with severity and relationship of AEs), and abnormalities in laboratory testing, vital signs, and 12-lead ECGs;Timepoint(s) of evaluation of this end point: at Week 16	—

Measure

Time frame

Secondary end point(s): - Percentage of participants with an improvement of = 50% from baseline in the CLASI-A score (CLASI-50) - Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of = 4 points from baseline - Mean change from baseline in CLASI-A score - Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of “0” - Number and proportion of participants experiencing SAEs, AEs (with severity and relationship of AEs), and abnormalities in laboratory testing, vital signs, and 12-lead ECGs;Timepoint(s) of evaluation of this end point: at Week 16

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Countries

Argentina, Australia, Canada, France, Germany, Poland, 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