SLEおよびCLE（SCLEおよび/またはDLE）におけるM5049を用いたWILLOW試験（WILLOW）

基本情報

NCT ID: NCT05162586
ステータス: 完了
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 456
治験依頼者名: EMD Serono

概要

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus \[SCLE\] and/or discoid lupus erythematosus \[DLE\]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.

対象疾患

Systemic Lupus Erythematosus

介入

Enpatoran low dose(DRUG)

Enpatoran medium dose(DRUG)

Enpatoran high dose(DRUG)

Placebo(DRUG)

依頼者（Sponsor）

Merck Kgaa, Darmstadt, Germany(INDUSTRY)

Emd Serono Research & Development Institute(INDUSTRY)

実施施設 (12)

NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

Chiba, Japan

医療法人社団英和美月会　高田クリニック

Sapporo, Japan

St. Luke's International Hospital - Dept of Immunology/Allergy

Chūōku, Japan

Saitama Medical Center - Dept of Rheumatology/Immunology

Kawagoe-shi, Japan

愛媛県立今治病院

Toon-shi, Japan

Tohoku University Hospital - Dept of Hematology/Immunology

Sendai, Japan

NHO Asahikawa Medical Center - Dept of Gastroenterology

Asahikawa-shi, Japan

医療法人明峯会　あおぞら内科リウマチ科クリニック

Kita-gun, Japan

Eiraku Clinic - Dept of Rheumatology

Kagoshima, Japan

東邦大学医療センター大橋病院

Meguro-ku, Japan

広島大学病院

Hiroshima, Japan

Kanazawa University Hospital - Dept of Rheumatology/Immunology

Kanazawa, Japan