SCLE、DLE、および/またはSLE患者を対象としたM5049を用いたWillow LTE試験（WILLOW LTE）

基本情報

NCT ID: NCT05540327
ステータス: 実施中（募集終了）
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 379
治験依頼者名: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

概要

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).

対象疾患

Systemic Lupus Erythematosus

介入

M5049 low dose(DRUG)

M5049 medium dose(DRUG)

M5049 high dose(DRUG)

Placebo(DRUG)

依頼者（Sponsor）

Merck Healthcare Kgaa, Darmstadt, Germany, An Affiliate Of Merck Kgaa, Darmstadt, Germany(INDUSTRY)

実施施設 (9)

医療法人社団英和美月会　高田クリニック

Sapporo, Japan

Eiraku Clinic - Dept of Rheumatology

Kagoshima, Japan

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

Chūōku, Japan

Saitama Medical Center - Dept of Rheumatology/Immunology

Kawagoe-shi, Japan

NHO Asahikawa Medical Center - Dept of Gastroenterology

Asahikawa-shi, Japan

NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

Chiba, 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

Tohoku University Hospital - Dept of Hematology/Immunology

Sendai, Japan

広島大学病院

Hiroshima, Japan