A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)
Status: Active_not_recruiting
Location: See all (122) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 76
Healthy Volunteers: f
View:
• Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
• Have a Body Mass Index (BMI) within the less than or equal to (\<=) 40 kilograms per meter square (inclusive) at Screening
• Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1
• Other protocol defined inclusion criteria could apply
Locations
United States
California
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance
Florida
Bay Area Arthritis and Osteoporosis
Brandon
Advance Medical Research Center
Miami
Indiana
Dawes Fretzin Dermatology Group, LLC
Indianapolis
Michigan
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc
Minnesota
University of Minnesota
Minneapolis
Ohio
Ohio State University - CTMO Parent
Columbus
Tennessee
Ramesh C Gupta, MD
Memphis
Other Locations
Argentina
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
Australia
Monash Medical Centre Clayton
Clayton
Veracity Clinical Research
Woolloongabba
Brazil
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
Bulgaria
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
Chile
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
China
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
Colombia
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
Greece
General Hospital of Athens Laiko
Athens
General Hospital Papageorgiou
Thessaloniki
Israel
Chaim Sheba Medical Center - pt
Ramat Gan
Japan
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
Mauritius
CAP Research Ltd
Quatre Bornes
Mexico
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
Medical Care & Research SA de CV
Mérida
Centro Medico del Angel
Mexicali
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
CAIMED Investigacion en salud S.A de C.V.
Mexico City
Clinstile, S.A. de C.V.
Mexico City
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
Torreón
Philippines
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
Poland
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
Republic of Korea
Gachon University Gil Medical Center
Incheon
Seoul National University Hospital
Seoul
Ajou University Hospital
Suwon
Republic of Moldova
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital Timofei Mosneaga
Chisinau
Romania
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
Serbia
Institute of Rheumatology
Belgrade
Institute of Rheumatology - Rheumatology
Belgrade
University Clinical Center of Serbia - Clinic of Alergology and Imunology
Belgrade
South Africa
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
Spain
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
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Taipei Veterans General Hospital
Taipei
Time Frame
Start Date: 2022-09-16
Completion Date: 2028-08-12
Participants
Target number of participants: 379
Treatments
Experimental: M5049 low dose + 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.
Experimental: M5049 medium dose+ 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.
Experimental: M5049 high dose + 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 .
Related Therapeutic Areas
Sponsors
Leads: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany