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

JRCT ID: jRCT2031210627

Registered date:23/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
• Date of first enrollment: 29/06/2022
• Target sample size: 18
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Greece,Japan,Israel,Japan,Mauritius,Japan,Mexico,Japan,Moldova,Japan,Philippines,Japan,Poland,Japan,Puerto Rico,Japan,Russia,Japan,Serbia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Ukrine,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

The following dosing regimens are proposed to be investigated in Cohort A over a treatment duration of at least 24 weeks: 25, 50 and 100 mg enpatoran twice per day administered orally in a tablet formulation without food restriction.
Cohort B is comprised of Part 1 and subsequent Part 2. In Cohort B Part 1, enpatoran 100 mg twice per day will be compared with placebo to determine futility of the treatment effect. Cohort B Part 2 will be initiated when approximately 60 participants have been enrolled in Part 1. Cohort B Part 2 doses will be initiated as enpatoran 25, 50 and 100 mg enpatoran twice per day compared to placebo and will be adapted based on the planned interim analyses without exceeding exposures at the highest clinically investigated dose.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both
• Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ishii Kyoko
• Secondary ID(s): NCT05162586