A Phase 2 Clinical Study to Assess the Safety and Efficacy of Deucravacitinib 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 erythematosus Class: 100000004858
MedDRA version: 21.1Level: LLTClassification code: 10013072Term: Discoid lupus erythematosus Class: 10040785
MedDRA version: 21.1Level: PTClassification code: 10057903Term: Subacute cutaneous lupus erythematosus Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-504161-22-00

Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 134

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

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
Main Objective: To evaluate the effect of two doses of deucravacitinib (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 deucravacitinib (3 mg BID and 6 mg BID) compared with placebo at Week 16, To assess the safety and tolerability of two doses of deucravacitinib (3 mg BID and 6 mg BID) compared with placebo;Primary end point(s): Percentage change from baseline in CLASI activity (CLASIA) score

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);Secondary end point(s):Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of = 4 points from baseline;Secondary end point(s):Mean change from baseline in CLASI-A score;Secondary end point(s):Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of 0;Secondary end point(s):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