A Phase 2 Clinical Study to Assess the Safety and Efficacy of BMS-986165 in Participants with Active DLE and/or SCLE
Phase 1
- Conditions
- Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)MedDRA version: 21.1Level: PTClassification code 10056509Term: Cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: PTClassification code 10057903Term: Subacute cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 21.1Level: LLTClassification code 10013072Term: Discoid lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-000071-21-FR
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br><br>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;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 Outcome Measures
Name Time Method Secondary end point(s): - Percentage of participants with an improvement of = 50% from baseline in the CLASI-A score (CLASI-50)<br>- Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of = 4 points from baseline<br>- Mean change from baseline in CLASI-A score<br>- Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of 0”<br>- 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