A Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care

Merck Biopharma Co., Ltd.0 个研究点目标入组 18 人开始时间: 2022年6月29日最近更新: 2025年5月27日

试验速览

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•Cohort A will have participants with CLE (active SCLE, and/or DLE) (CLASI-A => 8) or SLE with predominantly active lupus rash (CLASI-A => 8) Cohort B will have SLE participants who have moderate to high systemic disease activity (BILAG => 1A and/or 2B) with 1 or 2 of the following: CLASI A => 8 and/or SLEDAI => 6.

•Primary diagnosis of autoimmune or rheumatic disease other than SLE or CLE (discuss with Medical Monitor if overlap syndrome). Note: Secondary Sjogren's syndrome or an autoimmune thyroiditis are not exclusionary.
•Drug-induced lupus (SLE or CLE).
•Any condition including dermatological diseases other than cutaneous manifestations of SLE or CLE (e.g., psoriasis), or any uncontrolled disease (e.g., asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation.

CLASI-A

To evaluate the dose-response relationship of enpatoran in reducing disease activity based on CLASI-A

BICLA response rate

To evaluate the dose-response relationship of enpatoran in reducing disease activity based on BICLA response rate

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发起方