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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

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

456

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No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210627

Ishii Kyoko

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan

kyoko.ishii@merckgroup.com

Contact for Clinical Trial Information

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan

+81-3-6756-0800

MBJ_clinicaltrial_information@merckgroup.com

Complete

June. 10, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Both

Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

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.

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

+81-3-5550-7158

Mar. 28, 2022

+81-99-254-1125

Mar. 28, 2022

Argentina/Australia/Brazil/Bulgaria/Canada/Chile/China/Colombia/Greece/Israel/Mauritius/Mexico/Moldova/Philippines/Poland/Puerto Rico/Russia/Serbia/South Africa/Spain/Sweden/Ukrine/United States