The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: M5049 low doseDrug: M5049 medium doseDrug: M5049 high doseDrug: PlaceboDrug: M5049 very high dose
- Registration Number
- NCT05540327
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief 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 \[NCT05162586\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 532
- Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
- Have a Body Mass Index (BMI) within the >= 40 kilograms per meter square (inclusive) at Screening
- Other protocol defined inclusion criteria could apply
- Participants who experienced serious event(s) related to the study intervention during the WILLOW study
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
- Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 [(SARS-CoV-2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization
- Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
- Participation in any other investigational drug study after the WILLOW study Week 24
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M5049 low dose + Placebo M5049 low dose Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo. M5049 medium dose+ Placebo M5049 medium dose Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo. M5049 high dose + Placebo Placebo Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose . M5049 medium dose+ Placebo Placebo Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo. M5049 high dose + Placebo M5049 high dose Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose . M5049 very high dose + Placebo M5049 very high dose Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose. M5049 low dose + Placebo Placebo Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo. M5049 very high dose + Placebo Placebo Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.
- Primary Outcome Measures
Name Time Method Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) Baseline up to Week 50
- Secondary Outcome Measures
Name Time Method Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected Baseline up to Week 50 Percent Change from WILLOW Study Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Weeks 0, 2, 4, 12, 24, 36 and 48 Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48 Number of Participants With Based Composite Lupus Assessment (BICLA) Response At Weeks 24 and 48 Change from WILLOW Study Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Weeks 0, 2, 4, 12, 24, 36 and 48 Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48 Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response At Weeks 24 and 48
Trial Locations
- Locations (121)
Advance Medical Research Center
🇺🇸Miami, Florida, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Dawes Fretzin Dermatology Group, LLC
🇺🇸Indianapolis, Indiana, United States
Veracity Clinical Research
🇦🇺Woolloongabba, Australia
The Lundquist Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Ohio State University - CTMO Parent
🇺🇸Columbus, Ohio, United States
Hainan General Hospital
🇨🇳Haikou, China
Peking Union Medical College Hospital - Beijing Union Medical College Hospital
🇨🇳Beijing, China
The First Hospital of Jilin University
🇨🇳Changchun, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
🇨🇳Shanghai, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Saitama Medical Center - Dept of Rheumatology/Immunology
🇯🇵Kawagoe-shi, Japan
Kagawa University Hospital - Dept of Immunology/ Rheumatology
🇯🇵Kita-gun, Japan
Hospital General de Castellon - Servicio de Reumatologia
🇪🇸Castello, Spain
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
🇿🇦Cape Town, South Africa
Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
🇪🇸Santander, Spain
Hospital Regional Universitario de Malaga - Reumatology Dept
🇪🇸Malaga, Spain
Naidoo, A - Netcare Umhlanga Hospital
🇿🇦Umhlanga, South Africa
University of Pretoria Clinical Research Unit - Parent
🇿🇦Pretoria, South Africa
Monash Medical Centre Clayton
🇦🇺Clayton, Australia
Santa Casa de Misericórdia de Belo Horizonte
🇧🇷Belo Horizonte, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
🇧🇷Cuiabá, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
🇧🇷Sao Paulo, Brazil
Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
🇨🇱Los Lagos, Chile
UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
🇧🇬Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
🇧🇬Sofia, Bulgaria
CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
🇨🇱Santiago, Chile
CeCim Biocinetic
🇨🇱Santiago, Chile
The First Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, China
Dermacross
🇨🇱Santiago, Chile
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
West China Hospital, Sichuan University
🇨🇳Sichuan, China
Huashan Hospital, Fudan University - Neurology
🇨🇳Shanghai, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Healthy Medical Center
🇨🇴Zipaquirá, Colombia
Chaim Sheba Medical Center - pt
🇮🇱Ramat Gan, Israel
Diseño y Planeacion en Investigacion Medica S.C.
🇲🇽Guadalajara, Mexico
Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B
🇲🇽Mexico, Mexico
Centro de Investigacion Clínica GRAMEL S.C
🇲🇽Mexico, Mexico
S.C Delta Health Care S.R.L - Ponderas Academic Hospital
🇷🇴Bucuresti, Romania
Hospital Universitario Rio Hortega - Servicio de Medicina Interna
🇪🇸Valladolid, Spain
Twoja Przychodnia PCM
🇵🇱Poznan, Poland
CINME - Centro De Investigaciones Metabolicas
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
🇦🇷San Fernando, Argentina
Centro de Investigaciones Medicas Tucuman
🇦🇷Tucuman, Argentina
MC Artmed OOD
🇧🇬Plovdiv, Bulgaria
DCC 1 Sevlievo EOOD
🇧🇬Sevlievo, Bulgaria
Military Medical Academy - MHAT - Sofia
🇧🇬Sofia, Bulgaria
Bay Area Arthritis and Osteoporosis
🇺🇸Brandon, Florida, United States
PSORIAHUE-Medicina Interdisciplinar
🇦🇷San Miguel, Argentina
Clínica SER da Bahia
🇧🇷Graca, Brazil
DCC Focus 5 - MEOH OOD
🇧🇬Sofia, Bulgaria
Centro de Investigacion Medico Asistencial S.A.S
🇨🇴Barranquilla, Colombia
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
🇯🇵Chiba-shi, Japan
Hiroshima University Hospital
🇯🇵Hiroshima-shi, Japan
Tohoku University Hospital - Dept of Hematology/Immunology
🇯🇵Sendai-shi, Japan
Iloilo Doctors Hospital
🇵🇭Iloilo City, Philippines
Chinese General Hospital & Medical Center
🇵🇭Manila, Philippines
Prywatna Praktyka Lekarska prof Pawel Hrycaj
🇵🇱Koscian, Poland
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
Centro de Investigaciones Medicas Mar del Plata - CIM
🇦🇷Mar del Plata, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
🇦🇷San Juan, Argentina
Investigaciones Clinicas Tucuman
🇦🇷San Miguel de Tucuman, Argentina
Centro Dermatologico Schejtman
🇦🇷San Miguel, Argentina
CMiP - Centro Mineiro de Pesquisa
🇧🇷Juiz de Fora, Brazil
DCC 'Sveti Georgi' EOOD - Cardiology Office
🇧🇬Haskovo, Bulgaria
Centro Medico Prosalud
🇨🇱Santiago, Chile
General Hospital Papageorgiou
🇬🇷Thessaloniki, Greece
NHO Asahikawa Medical Center - Dept of Gastroenterology
🇯🇵Asahikawa-shi, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
AA MRC LLC Ahmed Arif Medical Research Center
🇺🇸Grand Blanc, Michigan, United States
Buenos Aires Skin
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Hospital Militar Central Dr. Cosme Argerich
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Instituto de Reumatologia
🇦🇷Mendoza, Argentina
Hospital Moinhos de Vento
🇧🇷Moinhos de Vento, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa
🇧🇷Sao Jose, Brazil
BioMedica Research Group - Psicomedica Clinical and Research Group
🇨🇱Santiago, Chile
Servimed S.A.S.
🇨🇴Bucaramanga, Colombia
Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
🇯🇵Sapporo-shi, Japan
Diseno y Planeacion en Investigacion Medica S.C.
🇲🇽Guadalajara, Mexico
Clinical Best Solutions - Warszawa
🇵🇱Warszawa, Poland
Centrul Medical Monza SRL - Arensia Exploratory Medicine
🇷🇴Bucharest, Romania
Institute of Rheumatology
🇷🇸Belgrade, Serbia
Ramesh C Gupta, MD
🇺🇸Memphis, Tennessee, United States
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
🇨🇴Medellin, Colombia
General Hospital of Athens Laiko
🇬🇷Athens, Greece
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Consultorio Privado Dr. Miguel Cortes Hernandez
🇲🇽Cuernavaca, Mexico
Centro de Estudios de Investigacion Basica y Clinica SC
🇲🇽Guadalajara, Mexico
Centro Medico del Angel
🇲🇽Mexicali, Mexico
Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
🇵🇭Quezon City, Philippines
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
🇵🇱Bialystok, Poland
Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie
🇷🇴Bucuresti, Romania
Spitalul Clinic "Sf. Maria" - parent
🇷🇴Bucuresti, Romania
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
🇨🇴Bogotá, Colombia
St. Luke's International Hospital - Dept of Immunology/Allergy
🇯🇵Chuo-ku, Japan
Eiraku Clinic - Dept of Rheumatology
🇯🇵Kagoshima-shi, Japan
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Clinstile, S.A. de C.V.
🇲🇽Ciudad de México, Mexico
Medical Care & Research SA de CV
🇲🇽Merida, Mexico
Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas
🇲🇽Mexico, Mexico
Grupo Medico Camino S.C.
🇲🇽Mexico, Mexico
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
🇲🇽Torreon, Mexico
University Clinical Center of Serbia - Clinic of Alergology and Imunology
🇷🇸Belgrade, Serbia
CAP Research Ltd
🇲🇺Quatre Bornes, Mauritius
CAIMED Investigacion en salud S.A de C.V.
🇲🇽Ciudad de México, Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
🇲🇽Monterrey, Mexico
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
🇲🇩Chisinau, Moldova, Republic of
Davao Doctors Hospital - Medicine
🇵🇭Davao City, Philippines
Mary Mediatrix Medical Center
🇵🇭Lipa City, Philippines
Ospital Ng Makati
🇵🇭Makati City, Philippines
Centrum Nowoczesnych Terapii Dobry Lekarz
🇵🇱Krakow, Poland
Institute of Rheumatology - Rheumatology
🇷🇸Belgrade, Serbia
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o
🇵🇱Szczecin, Poland
The Affiliated Drum Tower Hospital of Nanjing University
🇨🇳Nanjing, China