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

Last updated: June 27, 2025
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Active - Not Recruiting

Phase

2

Condition

Systemic Lupus Erythematosus

Musculoskeletal Diseases

Lupus

Treatment

M5049 high dose

Placebo

M5049 low dose

Clinical Study ID

NCT05540327
MS200569_0048
2022-000239-21
  • Ages 18-76
  • All Genders

Study Summary

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]).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the WillowStudy

  • Have a Body Mass Index (BMI) within the less than or equal to (<=) 40 kilograms permeter square (inclusive) at Screening

  • Participants who had successfully completed Week 48 of the Part 1 will have theopportunity to participate in the LTE Part 2. In exceptional cases and after Sponsorreview, participants who have completed the Week 48 visit of the Part 1 within theprevious 4-weeks may be considered for Part 2 participation based on eligibilityreview. Previous 4-weeks will be calculated from the Week 48 visit of Part 1

  • Other protocol defined inclusion criteria could apply

Exclusion

Exclusion Criteria:

  • Participants who experienced serious event(s) related to the study interventionduring the WILLOW study

  • Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with Long Term Extension (LTE)study participation

  • Ongoing or active clinically significant viral (including Severe acute respiratorysyndrome coronavirus 2 [(SARS-CoV-2)], bacterial or fungal infection, or any majorepisode of infection requiring hospitalization

  • Received LTE prohibited medication during the WILLOW study or after the WILLOW studyWeek 24

  • Participation in any other investigational drug study after the WILLOW study Week 24

  • Other protocol defined exclusion criteria could apply

Study Design

Total Participants: 379
Treatment Group(s): 5
Primary Treatment: M5049 high dose
Phase: 2
Study Start date:
September 16, 2022
Estimated Completion Date:
August 12, 2028

Connect with a study center

  • Centro de Investigaciones Medicas Mar del Plata - CIM

    Buenos Aires,
    Argentina

    Site Not Available

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • Centro Dermatologico Schejtman

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Militar Central Dr. Cosme Argerich

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • CINME - Centro De Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aires,
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Mar del Plata - CIM

    Mar del Plata,
    Argentina

    Site Not Available

  • Instituto de Reumatologia

    Mendoza,
    Argentina

    Site Not Available

  • Instituto CAICI - Instituto Centralizado de Asistencia e Investigaci

    Rosario,
    Argentina

    Site Not Available

  • Cordis S.A.

    Salta,
    Argentina

    Site Not Available

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

    San Fernando,
    Argentina

    Site Not Available

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

    San Juan,
    Argentina

    Site Not Available

  • Centro Dermatologico Schejtman

    San Miguel,
    Argentina

    Site Not Available

  • PSORIAHUE-Medicina Interdisciplinar

    San Miguel,
    Argentina

    Site Not Available

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucuman,
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Tucuman

    Tucuman,
    Argentina

    Site Not Available

  • Box Hill Hospital - PARENT

    Caulfield,
    Australia

    Site Not Available

  • Monash Medical Centre Clayton

    Clayton,
    Australia

    Site Not Available

  • Fiona Stanley Hospital - Haematology

    Murdoch,
    Australia

    Site Not Available

  • Royal Melbourne Hospital - PARENT

    Parkville,
    Australia

    Site Not Available

  • Westmead Hospital - PARENT

    Sydney,
    Australia

    Site Not Available

  • Colin Bayliss Research and Teaching Unit

    Victoria Park,
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba,
    Australia

    Site Not Available

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte,
    Brazil

    Site Not Available

  • Oncovida - Centro de Onco-Hematologia de Mato Grosso

    Cuiabá,
    Brazil

    Site Not Available

  • Edumed - Educação e Saúde SA

    Curitiba,
    Brazil

    Site Not Available

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza,
    Brazil

    Site Not Available

  • Clínica SER da Bahia

    Graca,
    Brazil

    Site Not Available

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora,
    Brazil

    Site Not Available

  • Hospital Bruno Born

    Lajeado,
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Moinhos de Vento,
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre,
    Brazil

    Site Not Available

  • Clínica SER da Bahia

    Salvador,
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo André,
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa

    Sao Jose,
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    Sao Paulo,
    Brazil

    Site Not Available

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo,
    Brazil

    Site Not Available

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

    São José do Rio Preto,
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo,
    Brazil

    Site Not Available

  • DCC 'Sveti Georgi' EOOD - Cardiology Office

    Haskovo,
    Bulgaria

    Site Not Available

  • Medical center Medconsult Pleven OOD

    Pleven,
    Bulgaria

    Site Not Available

  • MC Artmed OOD

    Plovdiv,
    Bulgaria

    Site Not Available

  • DCC 1 - Ruse, EOOD

    Ruse,
    Bulgaria

    Site Not Available

  • DCC 1 Sevlievo EOOD

    Sevlievo,
    Bulgaria

    Site Not Available

  • Medical Center-1-Sevlievo EOOD

    Sevlievo,
    Bulgaria

    Active - Recruiting

  • DCC Focus 5 - MEOH OOD

    Sofia,
    Bulgaria

    Site Not Available

  • Military Medical Academy - MHAT - Sofia

    Sofia,
    Bulgaria

    Site Not Available

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

    Sofia,
    Bulgaria

    Site Not Available

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

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT Prof. Dr. Stoyan Kirkovich AD

    Stara Zagora,
    Bulgaria

    Site Not Available

  • Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno

    Los Lagos,
    Chile

    Site Not Available

  • Clínica Alemana de Osorno

    Osorno,
    Chile

    Site Not Available

  • BioMedica Research Group - Psicomedica Clinical and Research Group

    Santiago,
    Chile

    Site Not Available

  • CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda

    Santiago,
    Chile

    Site Not Available

  • CeCim Biocinetic

    Santiago,
    Chile

    Site Not Available

  • Centro Medico Prosalud

    Santiago,
    Chile

    Site Not Available

  • Dermacross

    Santiago,
    Chile

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College

    Baotou,
    China

    Site Not Available

  • Peking Union Medical College Hospital - Beijing Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun,
    China

    Site Not Available

  • The 2nd Xiangya Hospital of Central South University

    Changsha,
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu,
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Site Not Available

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

  • Hainan General Hospital

    Haikou,
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot,
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang,
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    Nanjing,
    China

    Site Not Available

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing,
    China

    Site Not Available

  • Huashan Hospital, Fudan University - Neurology

    Shanghai,
    China

    Site Not Available

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

    Shanghai,
    China

    Site Not Available

  • Shanghai Skin Disease Hospital

    Shanghai,
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Sichuan,
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla,
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

    Bogotá,
    Colombia

    Site Not Available

  • Servimed S.A.S

    Bucaramanga,
    Colombia

    Site Not Available

  • Servimed S.A.S.

    Bucaramanga,
    Colombia

    Site Not Available

  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

    Medellin,
    Colombia

    Site Not Available

  • Healthy Medical Center

    Zipaquirá,
    Colombia

    Site Not Available

  • General Hospital of Athens Laiko

    Athens,
    Greece

    Site Not Available

  • University Hospital of Patra

    Patra,
    Greece

    Site Not Available

  • General Hospital Papageorgiou

    Thessaloniki,
    Greece

    Site Not Available

  • Skin and Venereal Diseases' Hospital

    Thessaloniki,
    Greece

    Site Not Available

  • Chaim Sheba Medical Center - pt

    Ramat Gan,
    Israel

    Site Not Available

  • NHO Asahikawa Medical Center - Dept of Gastroenterology

    Asahikawa-shi,
    Japan

    Site Not Available

  • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

    Chiba-shi,
    Japan

    Site Not Available

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

    Chuo-ku,
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima-shi,
    Japan

    Site Not Available

  • Eiraku Clinic - Dept of Rheumatology

    Kagoshima-shi,
    Japan

    Site Not Available

  • Saitama Medical Center - Dept of Rheumatology/Immunology

    Kawagoe-shi,
    Japan

    Site Not Available

  • Kagawa University Hospital - Dept of Immunology/ Rheumatology

    Kita-gun,
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo-shi,
    Japan

    Site Not Available

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

    Sapporo-shi,
    Japan

    Site Not Available

  • Tohoku University Hospital - Dept of Hematology/Immunology

    Sendai-shi,
    Japan

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • CAP Research Ltd

    Quatre Bornes,
    Mauritius

    Site Not Available

  • CAIMED Investigacion en salud S.A de C.V.

    Ciudad de México,
    Mexico

    Site Not Available

  • Clinstile, S.A. de C.V.

    Ciudad de México,
    Mexico

    Site Not Available

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

    Cuernavaca,
    Mexico

    Site Not Available

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca,
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Basica y Clinica SC

    Guadalajara,
    Mexico

    Site Not Available

  • Diseno y Planeacion en Investigacion Medica S.C.

    Guadalajara,
    Mexico

    Site Not Available

  • Diseño y Planeacion en Investigacion Medica S.C.

    Guadalajara,
    Mexico

    Site Not Available

  • Medical Care & Research SA de CV

    Merida,
    Mexico

    Site Not Available

  • Centro Medico del Angel

    Mexicali,
    Mexico

    Site Not Available

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico,
    Mexico

    Site Not Available

  • Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas

    Mexico,
    Mexico

    Site Not Available

  • Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B

    Mexico,
    Mexico

    Site Not Available

  • Grupo Medico Camino S.C.

    Mexico,
    Mexico

    Site Not Available

  • Centro Regiomontano de Estudios Clínicos Roma S.C.

    Monterrey,
    Mexico

    Site Not Available

  • Clinosar Mexico, S.A. de C.V.

    México,
    Mexico

    Site Not Available

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

    Torreon,
    Mexico

    Site Not Available

  • Medical Care & Research SA de CV

    Yucatan,
    Mexico

    Site Not Available

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

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • GreenCity Medical Center

    Angeles City, Pampanga,
    Philippines

    Site Not Available

  • Perpetual Succour Hospital

    Cebu City,
    Philippines

    Site Not Available

  • Davao Doctors Hospital - Medicine

    Davao City,
    Philippines

    Site Not Available

  • Iloilo Doctors Hospital

    Iloilo City,
    Philippines

    Site Not Available

  • Mary Mediatrix Medical Center

    Lipa City,
    Philippines

    Site Not Available

  • Ospital Ng Makati

    Makati City,
    Philippines

    Site Not Available

  • Chinese General Hospital & Medical Center

    Manila,
    Philippines

    Site Not Available

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health

    Quezon City,
    Philippines

    Site Not Available

  • Ospital Ng Makati

    Quezon City,
    Philippines

    Site Not Available

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health

    QuezonCity,
    Philippines

    Site Not Available

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

    Bialystok,
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Koscian,
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii Dobry Lekarz

    Krakow,
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Kraków,
    Poland

    Site Not Available

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole,
    Poland

    Site Not Available

  • Twoja Przychodnia PCM

    Poznan,
    Poland

    Site Not Available

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin,
    Poland

    Site Not Available

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

    Szczecin,
    Poland

    Site Not Available

  • Clinical Best Solutions - Warszawa

    Warszawa,
    Poland

    Site Not Available

  • Centrul Medical Monza SRL - Arensia Exploratory Medicine

    Bucharest,
    Romania

    Site Not Available

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

    Bucuresti,
    Romania

    Site Not Available

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

    Bucuresti,
    Romania

    Site Not Available

  • Spitalul Clinic "Sf. Maria" - parent

    Bucuresti,
    Romania

    Site Not Available

  • Institute of Rheumatology

    Belgrade,
    Serbia

    Site Not Available

  • Institute of Rheumatology - Rheumatology

    Belgrade,
    Serbia

    Site Not Available

  • University Clinical Center of Serbia - Clinic of Alergology and Imunology

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac,
    Serbia

    Site Not Available

  • Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat

    Cape Town,
    South Africa

    Site Not Available

  • University of Pretoria Clinical Research Unit - Parent

    Pretoria,
    South Africa

    Site Not Available

  • Naidoo, A - Netcare Umhlanga Hospital

    Umhlanga,
    South Africa

    Site Not Available

  • Accellacare - Alcobendas

    Alcobendas,
    Spain

    Site Not Available

  • Hospital General de Castellon - Servicio de Reumatologia

    Castello,
    Spain

    Site Not Available

  • Hospital General de Castellon - Servicio de Reumatologia

    Castellon,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia

    La Coruña,
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia

    Madrid,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga - Reumatology Dept

    Malaga,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga - Reumatology Dept

    Málaga,
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia

    Santander,
    Spain

    Site Not Available

  • Hospital Quironsalud Sagrado Corazon - Reumatologia

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario Dr. Peset - Servicio de Reumatologia

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitario Rio Hortega - Servicio de Medicina Interna

    Valladolid,
    Spain

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • University of Arizona Arthritis Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • University of California San Diego Medical Center

    La Jolla, California 92093-1503
    United States

    Site Not Available

  • The Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida 33511
    United States

    Site Not Available

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Advance Medical Research Center

    Miami, Florida 33135
    United States

    Site Not Available

  • HMD Research, LLC

    Orlando, Florida 32819
    United States

    Site Not Available

  • D&H Tamarac Research Center, LLC

    Tamarac, Florida 33321
    United States

    Site Not Available

  • CenExel ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Massachusetts General Hospital - Dermatology Clinic

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • A MRC LLC Ahmed Arif Medical Research Center

    Flint, Michigan 48504
    United States

    Site Not Available

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Superior Clinical Research, LLC

    Smithfield, North Carolina 27577
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ohio State University - CTMO Parent

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Toledo

    Toledo, Ohio 43614-2598
    United States

    Site Not Available

  • Rheumatology & Osteoporosis Institute of Oklahoma

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Ramesh C Gupta, MD

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Austin Regional Clinic, P.A.

    Austin, Texas 78731
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Site Not Available

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