The WILLOW study with enpatoran in SLE and CLE (SCLE and/or DLE)

Phase 2

• Conditions: Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

• Registration Number: JPRN-jRCT2031210627
• Lead Sponsor: Ishii Kyoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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.

Exclusion Criteria

1. 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.
2. Drug-induced lupus (SLE or CLE).
3. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dose-response relationship of enpatoran in reducing disease activity based on CLASI-A<br>To evaluate the dose-response relationship of enpatoran in reducing disease activity based on BICLA response rate