Phase
Condition
Systemic Lupus Erythematosus
Musculoskeletal Diseases
Lupus
Treatment
M5049 high dose
Placebo
M5049 low dose
Clinical Study ID
Ages 18-76 All Genders
Study Summary
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
Connect with a study center
Centro de Investigaciones Medicas Mar del Plata - CIM
Buenos Aires,
ArgentinaSite Not Available
Buenos Aires Skin
Ciudad Autonoma Buenos Aires,
ArgentinaSite Not Available
Centro Dermatologico Schejtman
Ciudad Autonoma Buenos Aires,
ArgentinaSite Not Available
Hospital Militar Central Dr. Cosme Argerich
Ciudad Autonoma Buenos Aires,
ArgentinaSite Not Available
CINME - Centro De Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires,
ArgentinaSite Not Available
Centro de Investigaciones Medicas Mar del Plata - CIM
Mar del Plata,
ArgentinaSite Not Available
Instituto de Reumatologia
Mendoza,
ArgentinaSite Not Available
Instituto CAICI - Instituto Centralizado de Asistencia e Investigaci
Rosario,
ArgentinaSite Not Available
Cordis S.A.
Salta,
ArgentinaSite Not Available
Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
San Fernando,
ArgentinaSite Not Available
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan,
ArgentinaSite Not Available
Centro Dermatologico Schejtman
San Miguel,
ArgentinaSite Not Available
PSORIAHUE-Medicina Interdisciplinar
San Miguel,
ArgentinaSite Not Available
Investigaciones Clinicas Tucuman
San Miguel de Tucuman,
ArgentinaSite Not Available
Centro de Investigaciones Medicas Tucuman
Tucuman,
ArgentinaSite Not Available
Box Hill Hospital - PARENT
Caulfield,
AustraliaSite Not Available
Monash Medical Centre Clayton
Clayton,
AustraliaSite Not Available
Fiona Stanley Hospital - Haematology
Murdoch,
AustraliaSite Not Available
Royal Melbourne Hospital - PARENT
Parkville,
AustraliaSite Not Available
Westmead Hospital - PARENT
Sydney,
AustraliaSite Not Available
Colin Bayliss Research and Teaching Unit
Victoria Park,
AustraliaSite Not Available
Veracity Clinical Research
Woolloongabba,
AustraliaSite Not Available
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte,
BrazilSite Not Available
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá,
BrazilSite Not Available
Edumed - Educação e Saúde SA
Curitiba,
BrazilSite Not Available
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza,
BrazilSite Not Available
Clínica SER da Bahia
Graca,
BrazilSite Not Available
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora,
BrazilSite Not Available
Hospital Bruno Born
Lajeado,
BrazilSite Not Available
Hospital Moinhos de Vento
Moinhos de Vento,
BrazilSite Not Available
Hospital Moinhos de Vento
Porto Alegre,
BrazilSite Not Available
Clínica SER da Bahia
Salvador,
BrazilSite Not Available
Faculdade de Medicina do ABC
Santo André,
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa
Sao Jose,
BrazilSite Not Available
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
Sao Paulo,
BrazilSite Not Available
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo,
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa
São José do Rio Preto,
BrazilSite Not Available
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo,
BrazilSite Not Available
DCC 'Sveti Georgi' EOOD - Cardiology Office
Haskovo,
BulgariaSite Not Available
Medical center Medconsult Pleven OOD
Pleven,
BulgariaSite Not Available
MC Artmed OOD
Plovdiv,
BulgariaSite Not Available
DCC 1 - Ruse, EOOD
Ruse,
BulgariaSite Not Available
DCC 1 Sevlievo EOOD
Sevlievo,
BulgariaSite Not Available
Medical Center-1-Sevlievo EOOD
Sevlievo,
BulgariaActive - Recruiting
DCC Focus 5 - MEOH OOD
Sofia,
BulgariaSite Not Available
Military Medical Academy - MHAT - Sofia
Sofia,
BulgariaSite Not Available
UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
Sofia,
BulgariaSite Not Available
UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
Sofia,
BulgariaSite Not Available
UMHAT Prof. Dr. Stoyan Kirkovich AD
Stara Zagora,
BulgariaSite Not Available
Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
Los Lagos,
ChileSite Not Available
Clínica Alemana de Osorno
Osorno,
ChileSite Not Available
BioMedica Research Group - Psicomedica Clinical and Research Group
Santiago,
ChileSite Not Available
CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
Santiago,
ChileSite Not Available
CeCim Biocinetic
Santiago,
ChileSite Not Available
Centro Medico Prosalud
Santiago,
ChileSite Not Available
Dermacross
Santiago,
ChileSite Not Available
The First Affiliated Hospital of Baotou Medical College
Baotou,
ChinaSite Not Available
Peking Union Medical College Hospital - Beijing Union Medical College Hospital
Beijing,
ChinaSite Not Available
The First Hospital of Jilin University
Changchun,
ChinaSite Not Available
The 2nd Xiangya Hospital of Central South University
Changsha,
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu,
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou,
ChinaSite Not Available
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
Hainan General Hospital
Haikou,
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot,
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing,
ChinaSite Not Available
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing,
ChinaSite Not Available
Huashan Hospital, Fudan University - Neurology
Shanghai,
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai,
ChinaSite Not Available
Shanghai Skin Disease Hospital
Shanghai,
ChinaSite Not Available
West China Hospital, Sichuan University
Sichuan,
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou,
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin,
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaSite Not Available
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla,
ColombiaSite Not Available
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
Bogotá,
ColombiaSite Not Available
Servimed S.A.S
Bucaramanga,
ColombiaSite Not Available
Servimed S.A.S.
Bucaramanga,
ColombiaSite Not Available
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Medellin,
ColombiaSite Not Available
Healthy Medical Center
Zipaquirá,
ColombiaSite Not Available
General Hospital of Athens Laiko
Athens,
GreeceSite Not Available
University Hospital of Patra
Patra,
GreeceSite Not Available
General Hospital Papageorgiou
Thessaloniki,
GreeceSite Not Available
Skin and Venereal Diseases' Hospital
Thessaloniki,
GreeceSite Not Available
Chaim Sheba Medical Center - pt
Ramat Gan,
IsraelSite Not Available
NHO Asahikawa Medical Center - Dept of Gastroenterology
Asahikawa-shi,
JapanSite Not Available
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
Chiba-shi,
JapanSite Not Available
St. Luke's International Hospital - Dept of Immunology/Allergy
Chuo-ku,
JapanSite Not Available
Hiroshima University Hospital
Hiroshima-shi,
JapanSite Not Available
Eiraku Clinic - Dept of Rheumatology
Kagoshima-shi,
JapanSite Not Available
Saitama Medical Center - Dept of Rheumatology/Immunology
Kawagoe-shi,
JapanSite Not Available
Kagawa University Hospital - Dept of Immunology/ Rheumatology
Kita-gun,
JapanSite Not Available
Hokkaido University Hospital
Sapporo-shi,
JapanSite Not Available
Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
Sapporo-shi,
JapanSite Not Available
Tohoku University Hospital - Dept of Hematology/Immunology
Sendai-shi,
JapanSite Not Available
Gachon University Gil Medical Center
Incheon,
Korea, Republic ofSite Not Available
Kyung Hee University Hospital at Gangdong
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon,
Korea, Republic ofSite Not Available
CAP Research Ltd
Quatre Bornes,
MauritiusSite Not Available
CAIMED Investigacion en salud S.A de C.V.
Ciudad de México,
MexicoSite Not Available
Clinstile, S.A. de C.V.
Ciudad de México,
MexicoSite Not Available
Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista
Cuernavaca,
MexicoSite Not Available
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca,
MexicoSite Not Available
Centro de Estudios de Investigacion Basica y Clinica SC
Guadalajara,
MexicoSite Not Available
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara,
MexicoSite Not Available
Diseño y Planeacion en Investigacion Medica S.C.
Guadalajara,
MexicoSite Not Available
Medical Care & Research SA de CV
Merida,
MexicoSite Not Available
Centro Medico del Angel
Mexicali,
MexicoSite Not Available
Centro de Investigacion Clínica GRAMEL S.C
Mexico,
MexicoSite Not Available
Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas
Mexico,
MexicoSite Not Available
Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B
Mexico,
MexicoSite Not Available
Grupo Medico Camino S.C.
Mexico,
MexicoSite Not Available
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey,
MexicoSite Not Available
Clinosar Mexico, S.A. de C.V.
México,
MexicoSite Not Available
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
Torreon,
MexicoSite Not Available
Medical Care & Research SA de CV
Yucatan,
MexicoSite Not Available
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
Chisinau,
Moldova, Republic ofSite Not Available
GreenCity Medical Center
Angeles City, Pampanga,
PhilippinesSite Not Available
Perpetual Succour Hospital
Cebu City,
PhilippinesSite Not Available
Davao Doctors Hospital - Medicine
Davao City,
PhilippinesSite Not Available
Iloilo Doctors Hospital
Iloilo City,
PhilippinesSite Not Available
Mary Mediatrix Medical Center
Lipa City,
PhilippinesSite Not Available
Ospital Ng Makati
Makati City,
PhilippinesSite Not Available
Chinese General Hospital & Medical Center
Manila,
PhilippinesSite Not Available
Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
Quezon City,
PhilippinesSite Not Available
Ospital Ng Makati
Quezon City,
PhilippinesSite Not Available
Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
QuezonCity,
PhilippinesSite Not Available
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok,
PolandSite Not Available
Prywatna Praktyka Lekarska prof Pawel Hrycaj
Koscian,
PolandSite Not Available
Centrum Nowoczesnych Terapii Dobry Lekarz
Krakow,
PolandSite Not Available
Centrum Medyczne Plejady
Kraków,
PolandSite Not Available
Twoja Przychodnia Opolskie Centrum Medyczne
Opole,
PolandSite Not Available
Twoja Przychodnia PCM
Poznan,
PolandSite Not Available
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin,
PolandSite Not Available
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o
Szczecin,
PolandSite Not Available
Clinical Best Solutions - Warszawa
Warszawa,
PolandSite Not Available
Centrul Medical Monza SRL - Arensia Exploratory Medicine
Bucharest,
RomaniaSite Not Available
S.C Delta Health Care S.R.L - Ponderas Academic Hospital
Bucuresti,
RomaniaSite Not Available
Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie
Bucuresti,
RomaniaSite Not Available
Spitalul Clinic "Sf. Maria" - parent
Bucuresti,
RomaniaSite Not Available
Institute of Rheumatology
Belgrade,
SerbiaSite Not Available
Institute of Rheumatology - Rheumatology
Belgrade,
SerbiaSite Not Available
University Clinical Center of Serbia - Clinic of Alergology and Imunology
Belgrade,
SerbiaSite Not Available
Clinical Center Kragujevac
Kragujevac,
SerbiaSite Not Available
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
Cape Town,
South AfricaSite Not Available
University of Pretoria Clinical Research Unit - Parent
Pretoria,
South AfricaSite Not Available
Naidoo, A - Netcare Umhlanga Hospital
Umhlanga,
South AfricaSite Not Available
Accellacare - Alcobendas
Alcobendas,
SpainSite Not Available
Hospital General de Castellon - Servicio de Reumatologia
Castello,
SpainSite Not Available
Hospital General de Castellon - Servicio de Reumatologia
Castellon,
SpainSite Not Available
Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia
La Coruña,
SpainSite Not Available
Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
Madrid,
SpainSite Not Available
Hospital Regional Universitario de Malaga - Reumatology Dept
Malaga,
SpainSite Not Available
Hospital Regional Universitario de Malaga - Reumatology Dept
Málaga,
SpainSite Not Available
Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
Santander,
SpainSite Not Available
Hospital Quironsalud Sagrado Corazon - Reumatologia
Sevilla,
SpainSite Not Available
Hospital Universitario Dr. Peset - Servicio de Reumatologia
Valencia,
SpainSite Not Available
Hospital Universitario Rio Hortega - Servicio de Medicina Interna
Valladolid,
SpainSite Not Available
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei,
TaiwanSite Not Available
Mayo Clinic Scottsdale
Scottsdale, Arizona 85259
United StatesSite Not Available
University of Arizona Arthritis Center
Tucson, Arizona 85724
United StatesSite Not Available
University of California San Diego Medical Center
La Jolla, California 92093-1503
United StatesSite Not Available
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Bay Area Arthritis and Osteoporosis
Brandon, Florida 33511
United StatesSite Not Available
University of Florida College of Medicine Jacksonville
Jacksonville, Florida 32207
United StatesSite Not Available
Advance Medical Research Center
Miami, Florida 33135
United StatesSite Not Available
HMD Research, LLC
Orlando, Florida 32819
United StatesSite Not Available
D&H Tamarac Research Center, LLC
Tamarac, Florida 33321
United StatesSite Not Available
CenExel ForCare Clinical Research
Tampa, Florida 33613
United StatesSite Not Available
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana 46250
United StatesSite Not Available
Massachusetts General Hospital - Dermatology Clinic
Boston, Massachusetts 02114
United StatesSite Not Available
A MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan 48504
United StatesSite Not Available
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan 48439
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Superior Clinical Research, LLC
Smithfield, North Carolina 27577
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Ohio State University - CTMO Parent
Columbus, Ohio 43210
United StatesSite Not Available
University of Toledo
Toledo, Ohio 43614-2598
United StatesSite Not Available
Rheumatology & Osteoporosis Institute of Oklahoma
Tulsa, Oklahoma 74136
United StatesSite Not Available
Ramesh C Gupta, MD
Memphis, Tennessee 38119
United StatesSite Not Available
Austin Regional Clinic, P.A.
Austin, Texas 78731
United StatesSite Not Available
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas 76034
United StatesSite Not Available
Jordan Valley Dermatology Center
South Jordan, Utah 84095
United StatesSite Not Available
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