The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

September 16, 2022

Primary Completion Date

August 12, 2028

Study Completion Date

August 12, 2028

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

M5049 low dose

Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.

DRUG

M5049 medium dose

Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.

DRUG

M5049 high dose

Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.

DRUG

Placebo

Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.

Trial Locations (122)

33135

Advance Medical Research Center, Miami

33511

Bay Area Arthritis and Osteoporosis, Brandon

38119

Ramesh C Gupta, MD, Memphis

43210

Ohio State University - CTMO Parent, Columbus

46250

Dawes Fretzin Dermatology Group, LLC, Indianapolis

48439

AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc

55455

University of Minnesota, Minneapolis

90502

The Lundquist Institute at Harbor-UCLA Medical Center, Torrance

Unknown

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

CINME - Centro De Investigaciones Metabolicas, Buenos Aires

Buenos Aires Skin, 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 alta Complejidad San Isidro S.A (IMAC), San Fernando

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

Centro Dermatologico Schejtman, San Miguel

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

Veracity Clinical Research, Woolloongabba

Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte

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

Clínica SER da Bahia, Graça

CMiP - Centro Mineiro de Pesquisa, Juiz de Fora

Hospital Moinhos de Vento, Moinhos de Vento

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa, São José

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

DCC 'Sveti Georgi' EOOD - Cardiology Office, Haskovo

MC Artmed OOD, Plovdiv

DCC 1 Sevlievo EOOD, Sevlievo

DCC Focus 5 - MEOH OOD, Sofia

Military Medical Academy - MHAT - Sofia, Sofia

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

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

Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno, Los Lagos

BioMedica Research Group - Psicomedica Clinical and Research Group, Santiago

CeCim Biocinetic, Santiago

Centro Medico Prosalud, Santiago

CIEC- Centro Internacional de Estudios Clinicos - 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

Guangdong Provincial People's Hospital, Guangzhou

Hainan General Hospital, Haikou

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

The Second Affiliated Hospital of Nanchang University, Nanchang

The Affiliated Drum Tower Hospital of Nanjing University, Nanjing

Huashan Hospital, Fudan University - Neurology, Shanghai

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

Shanghai Skin Disease Hospital, Shanghai

West China Hospital, Sichuan University, Sichuan

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 SAS. CIREEM, Bogotá

Servimed S.A.S., Bucaramanga

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS, Medellín

Healthy Medical Center, Zipaquirá

General Hospital of Athens Laiko, Athens

General Hospital Papageorgiou, 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, Hiroshima

Eiraku Clinic - Dept of Rheumatology, Kagoshima

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

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

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

Tohoku University Hospital - Dept of Hematology/Immunology, Sendai

CAP Research Ltd, Quatre Bornes

Consultorio Privado Dr. Miguel Cortes Hernandez, Cuernavaca

Centro de Estudios de Investigacion Basica y Clinica SC, Guadalajara

Diseno y Planeacion en Investigacion Medica S.C., Guadalajara

Diseño y Planeacion en Investigacion Medica S.C., Guadalajara

Centro Medico del Angel, Mexicali

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

Clinstile, S.A. de C.V., Mexico City

Medical Care & Research SA de CV, Mérida

Centro de Investigacion Clínica GRAMEL S.C, México

Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas, México

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

Grupo Medico Camino S.C., México

Centro Regiomontano de Estudios Clínicos Roma S.C., Monterrey

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

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

Davao Doctors Hospital - Medicine, Davao City

Iloilo Doctors Hospital, Iloilo City

Mary Mediatrix Medical Center, Lipa City

Ospital Ng Makati, Makati City

Chinese General Hospital & Medical Center, Manila

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

Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty, Bialystok

Prywatna Praktyka Lekarska prof Pawel Hrycaj, Kościan

Centrum Medyczne Plejady, Krakow

Centrum Nowoczesnych Terapii Dobry Lekarz, Krakow

Twoja Przychodnia PCM, Poznan

Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o, 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

Institute of Rheumatology - Rheumatology, Belgrade

Institute of Rheumatology, Belgrade

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

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

Gachon University Gil Medical Center, Incheon

Seoul National University Hospital, Seoul

Ajou University Hospital, Suwon

Hospital General de Castellon - Servicio de Reumatologia, Castelló

Hospital Regional Universitario de Malaga - Reumatology Dept, Málaga

Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia, Santander

Hospital Universitario Rio Hortega - Servicio de Medicina Interna, Valladolid

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Taipei Veterans General Hospital, Taipei

All Listed Sponsors
lead

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY