The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

PHASE2CompletedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

November 20, 2024

Study Completion Date

November 20, 2024

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Enpatoran low dose

Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.

DRUG

Enpatoran medium dose

Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.

DRUG

Enpatoran high dose

Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.

DRUG

Placebo

Participants will receive placebo matched to Enpatoran up to 24 weeks.

Trial Locations (153)

27577

Across the Life Span, Smithfield

30518

RNA America Health Sciences, Sugar Hill

32819

HMD Research, LLC, Orlando

33014

Charisma Medical and Research Center, Miami Lakes

33135

Advance Medical Research Center, Miami

33165

New Horizon Research Center, Inc, Miami

33321

D&H Tamarac Research Center, LLC, Tamarac

33511

Bay Area Arthritis and Osteoporosis, Brandon

38119

Ramesh C Gupta, MD - Memphis, TN, Memphis

43215

Ohio State University - CTMO Parent, Columbus

46256

Dawes Fretzin Dermatology Group, LLC, Indianapolis

48439

AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc

55455

University of Minnesota, Minneapolis

90509

The Lundquist Institute at Harbor-UCLA Medical Center, Torrance

Unknown

CINME - Centro De Investigaciones Metabolicas, Buenos Aires

Buenos Aires Skin, Ciudad Autonoma Buenos Aires

Centro Dermatologico Schejtman, Ciudad Autonoma Buenos Aires

Hospital Militar Central Dr. Cosme Argerich, Ciudad Autonoma Buenos Aires

Centro de Investigaciones Medicas Mar del Plata - CIM, Mar del Plata

Instituto de Reumatologia, Mendoza

Instituto Medico de la Fundacion Estudios Clinicos, Rosario

Instituto Medico de alta Complejidad San Isidro S.A (IMAC), San Fernando

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica, San Juan

PSORIAHUE-Medicina Interdisciplinar, San Miguel

Centro de Investigaciones Medicas Tucuman, San Miguel de Tucumán

Investigaciones Clinicas Tucuman, San Miguel de Tucumán

Monash Medical Centre Clayton, Clayton

Westmead Hospital - SUPERSEDED, Westmead

Veracity Clinical Research, Woolloongabba

Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte

Oncovida - Centro de Onco-Hematologia de Mato Grosso, Cuiabá

CETI - Centro de Estudos em Terapias Inovadoras Ltda., Curitiba

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará, Fortaleza

CMiP - Centro Mineiro de Pesquisa, Juiz de Fora

Hospital Bruno Born, Lajeado

Hospital Moinhos de Vento, Porto Alegre

Clínica SER da Bahia, Salvador

Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa, São José do Rio Preto

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos, São Paulo

CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo

DCC 'Sveti Georgi' EOOD - Cardiology Office, Haskovo

MC Artmed OOD, Plovdiv

Medical Center-1-Sevlievo EOOD, Sevlievo

"DCC Alexandrovska, EOOD", Sofia

Military Medical Academy - MHAT - Sofia - Department of Rheumatology, Sofia

"UMHAT Sv. Ivan Rilski, EAD - Clinic of Rheumatology", Sofia

Clínica Alemana de Osorno, Osorno

BioMedica Research Group - Psicomedica Clinical and Research Group, Santiago

CeCim Biocinetic, Santiago

Centro Medico Prosalud, Santiago

CIEC - Centro Internacional de Estudios Clínicos - Valenzuela Y Compania Ltda, Santiago

Dermacross, Santiago

The First Affiliated Hospital of Baotou Medical College, Baotou

Peking Union Medical College Hospital - Beijing Union Medical College Hospital, Beijing

The First Hospital of Jilin University, Changchun

The 2nd Xiangya Hospital of Central South University, Changsha

West China Hospital, Sichuan University, Chengdu

Guangdong Provincial People's Hospital - Oncology, Guangzhou

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

Hainan General Hospital, Haikou

The Affiliated Hospital of Inner Mongolia Medical University, Hohhot

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

The Second Affiliated Hospital of Nanchang University, Nanchang

Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing

The Affiliated Drum Tower Hospital of Nanjing University, Nanjing

Huashan Hospital, Fudan University, Shanghai

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch, Shanghai

Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai

Shanghai Skin Disease Hospital, Shanghai

The First Affiliated Hospital of Soochow University, Suzhou

Tianjin Medical University General Hospital, Tianjin

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

Centro de Investigacion Medico Asistencial S.A.S, Barranquilla

Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S., Bogotá

Servimed S.A.S., Bucaramanga

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS, Medellín

Healthy Medical Center, Zipaquirá

"Andreas Syggros Hospital - Department of Dermatology", Athens

General Hospital of Athens Laiko, Athens

University Hospital of Patra, Pátrai

"General Hospital of Thessaloniki Hippokration", Thessaloniki

General Hospital Papageorgiou, Thessaloniki

Skin and Venereal Diseases' Hospital, Thessaloniki

Chaim Sheba Medical Center - pt, Ramat Gan

NHO Asahikawa Medical Center - Dept of Gastroenterology, Asahikawa-shi

NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology, Chiba

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

Hiroshima University Hospital - Dept of Rheumatology/Immunology, Hiroshima

Eiraku Clinic - Dept of Rheumatology, Kagoshima

Kanazawa University Hospital - Dept of Rheumatology/Immunology, Kanazawa

Saitama Medical Center - Dept of Rheumatology/Immunology, Kawagoe-shi

Kagawa University Hospital - Dept of Immunology/ Rheumatology, Kita-gun

Toho University Ohashi Medical Center - Dept of Immunology/Rheumatology, Meguro-ku

Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog, Sapporo

Tohoku University Hospital - Dept of Hematology/Immunology, Sendai

Ehime University Hospital - Dept of Immunology/Rheumatology, Toon-shi

CAP Research Ltd, Quatre Bornes

Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista, Cuernavaca

Centro de Estudios de Investigacion Basica y Clinica SC, Guadalajara

Centro Medico del Angel, Mexicali

CAIMED Investigacion en salud S.A de C.V., Mexico City

Centro de Investigacion Clínica GRAMEL S.C, México

Citer, Centro de Investigación Y Tratamiento de Las Enfermedades Reumaticas Sa de Cv, México

Clinstile, S.A. de C.V., México

Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B, México

Grupo Medico Camino S.C., México

CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni, Torreón

Medical Care & Research SA de CV, Yucatán

"ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital Timofei Mosneaga", Chisinau

Perpetual Succour Hospital, Cebu City

Davao Doctors Hospital - Medicine, Davao City

Iloilo Doctors Hospital, Iloilo City

Mary Mediatrix Medical Center, Lipa City

Chinese General Hospital & Medical Center, Manila

Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health, Quezon City

Ospital Ng Makati, Quezon City

Nova Reuma Spolka Partnerska, Bialystok

Prywatna Praktyka Lekarska prof Pawel Hrycaj, Kościan

Centrum Medyczne Plejady, Krakow

Centrum Nowoczesnych Terapii Dobry Lekarz, Krakow

Twoja Przychodnia Opolskie Centrum Medyczne, Opole

Twoja Przychodnia PCM, Poznan

Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin

Clinical Best Solutions - Warszawa, Warsaw

Centrul Medical Monza SRL - Arensia Exploratory Medicine, Bucharest

S.C Delta Health Care S.R.L - Ponderas Academic Hospital, Bucharest

"Spitalul Clinic Sf. Maria - Clinica de Medicina Interna si Reumatologie", Bucharest

"Spitalul Clinic Sf. Maria - parent", Bucharest

Spitalul Clinic Colentina - parent, Bucharest

Sc Medaudio-Optica SRL, Râmnicu Vâlcea

Institute of Rheumatology- 1, Belgrade

Institute of Rheumatology-1, Belgrade

Institute of Rheumatology, Belgrade

University Clinical Center of Serbia - Clinic of Alergology and Imunology, Belgrade

University Clinical Center Kragujevac, Kragujevac

Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat, Cape Town

University of Pretoria Clinical Research Unit - Parent, Pretoria

Naidoo, A - Netcare Umhlanga Hospital, Umhlanga

Pusan National University Hospital, Busan

Gachon University Gil Medical Center, Incheon

Seoul National University Hospital, Seoul

Ajou University Hospital, Suwon

Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia, A Coruña

Hospital General de Castellon - Servicio de Reumatologia, Castelló

Hospital Universitario 12 de Octubre - Servicio de Reumatologia, Madrid

Hospital Regional Universitario de Malaga - Reumatology Dept, Málaga

Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia, Santander

Hospital Quironsalud Sagrado Corazon - Reumatologia, Seville

Hospital Universitario Dr. Peset - Servicio de Reumatologia, Valencia

Hospital Universitario Rio Hortega - Servicio de Medicina Interna, Valladolid

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Cheng Hsin General Hospital, Taipei

Taipei Veterans General Hospital, Taipei

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY