The WILLOW study with enpatoran in SLE and CLE (SCLE and/or DLE)
- Conditions
- Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-510872-18-00
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 508
Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8, Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8, Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids, Other protocol defined inclusion criteria could apply
Autoimmune or rheumatic disease other than SLE or CLE, Dermatological diseases other than cutaneous manifestations of SLE or CLE, Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder, Ongoing or active clinically significant viral, bacterial, or fungal infection, History of uncontrolled seizures or other neurological disorder, History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus, History of malignancy, Other protocol defined exclusion criteria could apply
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 dose-response relationship of enpatoran in reducing disease activity based on CLASI-A;Secondary Objective: To evaluate the dose-response relationship of enpatoran in reducing disease activity based on BICLA response rate;Primary end point(s): Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16, Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
- Secondary Outcome Measures
Name Time Method