The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05162586 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
EMD Serono Research & Development Institute, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Responsible |
Principal Investigator Affiliation | EMD Serono Research & Development Institute, Inc. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Greece, Israel, Japan, Korea, Republic of, Mauritius, Mexico, Moldova, Republic of, Philippines, Poland, Romania, Serbia, South Africa, Spain, Taiwan, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
Study Website: | View Trial Website |
Placebo Comparator: Cohort A: Placebo
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.
Experimental: Cohort A: Enpatoran low dose
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.
Experimental: Cohort A: Enpatoran medium dose
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.
Experimental: Cohort A: Enpatoran high dose
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.
Placebo Comparator: Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .
Experimental: Cohort B (Part 1 + Part 2): Enpatoran high dose
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.
Experimental: Cohort B (Part 2): Enpatoran low dose
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive low dose of M5049.
Experimental: Cohort B (Part 2): Enpatoran medium dose
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive medium dose of Enpatoran.
Drug: - Enpatoran low dose
Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.
Drug: - Enpatoran medium dose
Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.
Drug: - Enpatoran high dose
Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.
Drug: - Placebo
Participants will receive placebo matched to Enpatoran up to 24 weeks.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90509
Status
Recruiting
Address
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
Status
Recruiting
Address
Charisma Medical and Research Center
Miami Lakes, Florida, 33014
Status
Recruiting
Address
Advance Medical Research Center
Miami, Florida, 33135
Status
Recruiting
Address
New Horizon Research Center, Inc
Miami, Florida, 33165
Status
Recruiting
Address
HMD Research, LLC
Orlando, Florida, 32819
Status
Recruiting
Address
D&H Tamarac Research Center, LLC
Tamarac, Florida, 33321
Status
Withdrawn
Address
Model Research Center, LLC
Tampa, Florida, 33615
Status
Recruiting
Address
RNA America Health Sciences
Sugar Hill, Georgia, 30518
Status
Recruiting
Address
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46256
Status
Recruiting
Address
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439
Status
Recruiting
Address
University of Minnesota
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
Across the Life Span
Smithfield, North Carolina, 27577
Status
Recruiting
Address
Ohio State University - CTMO Parent
Columbus, Ohio, 43215
Status
Withdrawn
Address
University of Toledo - PARENT
Toledo, Ohio, 43614
Status
Recruiting
Address
Rheumatology & Osteoporosis Institute of Oklahoma
Tulsa, Oklahoma, 74137
Status
Recruiting
Address
Ramesh C Gupta, MD - Memphis, TN
Memphis, Tennessee, 38119
Status
Withdrawn
Address
Austin Regional Clinic, P.A.
Austin, Texas, 78731
Status
Recruiting
Address
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
Status
Recruiting
Address
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Status
Recruiting
Address
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, ,
Status
Recruiting
Address
Centro Dermatologico Schejtman
Ciudad Autonoma Buenos Aires, ,
Status
Recruiting
Address
Hospital Militar Central Dr. Cosme Argerich
Ciudad Autonoma Buenos Aires, ,
Status
Recruiting
Address
CINME - Centro De Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires, ,
Status
Recruiting
Address
Centro de Investigaciones Medicas Mar del Plata - CIM
Mar del Plata, ,
Status
Recruiting
Address
Instituto de Reumatologia
Mendoza, ,
Status
Recruiting
Address
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, ,
Status
Withdrawn
Address
Investigaciones Clínicas Salta (ICSAL)
Salta, ,
Status
Recruiting
Address
Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
San Fernando, ,
Status
Recruiting
Address
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, ,
Status
Recruiting
Address
Investigaciones Clinicas Tucuman
San Miguel de Tucuman, ,
Status
Recruiting
Address
PSORIAHUE-Medicina Interdisciplinar
San Miguel, ,
Status
Recruiting
Address
Centro de Investigaciones Medicas Tucuman
Tucuman, ,
Status
Recruiting
Address
Box Hill Hospital - PARENT
Caulfield, ,
Status
Recruiting
Address
Monash Medical Centre Clayton
Clayton, ,
Status
Recruiting
Address
Fiona Stanley Hospital - Haematology
Murdoch, ,
Status
Recruiting
Address
Royal Melbourne Hospital - PARENT
Parkville, ,
Status
Recruiting
Address
Westmead Hospital - SUPERSEDED
Westmead, ,
Status
Recruiting
Address
Veracity Clinical Research
Woolloongabba, ,
Status
Recruiting
Address
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, ,
Status
Recruiting
Address
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá, ,
Status
Recruiting
Address
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba, ,
Status
Withdrawn
Address
Edumed - Educação e Saúde SA
Curitiba, ,
Status
Recruiting
Address
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, ,
Status
Recruiting
Address
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, ,
Status
Recruiting
Address
Hospital Bruno Born
Lajeado, ,
Status
Recruiting
Address
Hospital Moinhos de Vento
Porto Alegre, ,
Status
Recruiting
Address
Clínica SER da Bahia
Salvador, ,
Status
Recruiting
Address
Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa
Sao Jose do Rio Preto, ,
Status
Recruiting
Address
CPCLIN - Centro de Pesquisas Clínicas Ltda.
Sao Paulo, ,
Status
Recruiting
Address
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, ,
Status
Recruiting
Address
DCC 'Sveti Georgi' EOOD - Cardiology Office
Haskovo, ,
Status
Withdrawn
Address
Medical center Medconsult Pleven OOD
Pleven, ,
Status
Recruiting
Address
Medical Center-1-Sevlievo EOOD
Sevlievo, ,
Status
Recruiting
Address
DCC "Alexandrovska", EOOD
Sofia, ,
Status
Recruiting
Address
DCC Focus 5 - MEOH OOD
Sofia, ,
Status
Recruiting
Address
Military Medical Academy - MHAT - Sofia - Department of Rheumatology
Sofia, ,
Status
Recruiting
Address
UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
Sofia, ,
Status
Recruiting
Address
UMHAT Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, ,
Status
Recruiting
Address
Clínica Alemana de Osorno
Osorno, ,
Status
Recruiting
Address
BioMedica Research Group - Psicomedica Clinical and Research Group
Santiago, ,
Status
Recruiting
Address
Centro Medico Prosalud
Santiago, ,
Status
Recruiting
Address
CIEC - Centro Internacional de Estudios Clínicos - Valenzuela Y Compania Ltda
Santiago, ,
Status
Recruiting
Address
The First Affiliated Hospital of Baotou Medical College
Baotou, ,
Status
Recruiting
Address
Peking Union Medical College Hospital - Beijing Union Medical College Hospital
Beijing, ,
Status
Recruiting
Address
The First Hospital of Jilin University
Changchun, ,
Status
Recruiting
Address
The 2nd Xiangya Hospital of Central South University
Changsha, ,
Status
Recruiting
Address
West China Hospital, Sichuan University
Chengdu, ,
Status
Recruiting
Address
Guangdong Provincial People's Hospital - Oncology
Guangzhou, ,
Status
Recruiting
Address
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, ,
Status
Recruiting
Address
Hainan General Hospital
Haikou, ,
Status
Recruiting
Address
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, ,
Status
Recruiting
Address
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, ,
Status
Recruiting
Address
The Second Affiliated Hospital of Nanchang University
Nanchang, ,
Status
Recruiting
Address
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, ,
Status
Recruiting
Address
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, ,
Status
Recruiting
Address
Huashan Hospital, Fudan University
Shanghai, ,
Status
Recruiting
Address
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, ,
Status
Recruiting
Address
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, ,
Status
Recruiting
Address
Shanghai Skin Disease Hospital
Shanghai, ,
Status
Recruiting
Address
The First Affiliated Hospital of Soochow University
SuZhou, ,
Status
Recruiting
Address
Tianjin Medical University General Hospital
Tianjin, ,
Status
Recruiting
Address
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, ,
Status
Recruiting
Address
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, ,
Status
Recruiting
Address
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
Bogotá, ,
Status
Recruiting
Address
Servimed S.A.S.
Bucaramanga, ,
Status
Recruiting
Address
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Medellin, ,
Status
Recruiting
Address
Healthy Medical Center
Zipaquirá, ,
Status
Recruiting
Address
"Andreas Syggros" Hospital - Department of Dermatology
Athens, ,
Status
Recruiting
Address
General Hospital of Athens Laiko
Athens, ,
Status
Recruiting
Address
General Hospital of Athens Laiko
Athens, ,
Status
Recruiting
Address
University Hospital of Patra
Patra, ,
Status
Recruiting
Address
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, ,
Status
Recruiting
Address
General Hospital Papageorgiou
Thessaloniki, ,
Status
Recruiting
Address
Skin and Venereal Diseases' Hospital
Thessaloniki, ,
Status
Recruiting
Address
Chaim Sheba Medical Center - pt
Ramat Gan, ,
Status
Recruiting
Address
NHO Asahikawa Medical Center - Dept of Gastroenterology
Asahikawa-shi, ,
Status
Recruiting
Address
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
Chiba-shi, ,
Status
Recruiting
Address
St. Luke's International Hospital - Dept of Immunology/Allergy
Chuo-ku, ,
Status
Recruiting
Address
Hiroshima University Hospital - Dept of Rheumatology/Immunology
Hiroshima-shi, ,
Status
Recruiting
Address
Eiraku Clinic - Dept of Rheumatology
Kagoshima-shi, ,
Status
Recruiting
Address
Kanazawa University Hospital - Dept of Rheumatology/Immunology
Kanazawa-shi, ,
Status
Recruiting
Address
Saitama Medical Center - Dept of Rheumatology/Immunology
Kawagoe-shi, ,
Status
Recruiting
Address
Kagawa University Hospital - Dept of Immunology/ Rheumatology
Kita-gun, ,
Status
Recruiting
Address
Toho University Ohashi Medical Center - Dept of Immunology/Rheumatology
Meguro-ku, ,
Status
Recruiting
Address
Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
Sapporo-shi, ,
Status
Recruiting
Address
Tohoku University Hospital - Dept of Hematology/Immunology
Sendai-shi, ,
Status
Recruiting
Address
Ehime University Hospital - Dept of Immunology/Rheumatology
Toon-shi, ,
Status
Recruiting
Address
Pusan National University Hospital
Busan, ,
Status
Recruiting
Address
Gachon University Gil Medical Center
Incheon, ,
Status
Withdrawn
Address
Kyung Hee University Hospital at Gangdong:
Seoul, ,
Status
Recruiting
Address
Seoul National University Hospital
Seoul, ,
Status
Recruiting
Address
Ajou University Hospital
Suwon, ,
Status
Recruiting
Address
CAP Research Ltd
Quatre Bornes, ,
Status
Recruiting
Address
CAIMED Investigacion en salud S.A de C.V.
Ciudad de México, ,
Status
Recruiting
Address
Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista
Cuernavaca, ,
Status
Recruiting
Address
Centro de Estudios de Investigacion Basica y Clinica SC
Guadalajara, ,
Status
Withdrawn
Address
Consultorio Médico del Dr. Federico Galván Villegas
Guadalajara, ,
Status
Recruiting
Address
Diseño y Planeacion en Investigacion Medica S.C.
Guadalajara, ,
Status
Recruiting
Address
Centro Medico del Angel
Mexicali, ,
Status
Recruiting
Address
Centro de Investigacion Clínica GRAMEL S.C
Mexico, ,
Status
Recruiting
Address
Citer, Centro de Investigación Y Tratamiento de Las Enfermedades Reumaticas Sa de Cv
Mexico, ,
Status
Recruiting
Address
Clinstile, S.A. de C.V.
Mexico, ,
Status
Recruiting
Address
Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B
Mexico, ,
Status
Recruiting
Address
Grupo Medico Camino S.C.
Mexico, ,
Status
Recruiting
Address
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, ,
Status
Withdrawn
Address
AMAF Clinical Research S.C
México, ,
Status
Recruiting
Address
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
Torreon, ,
Status
Recruiting
Address
Medical Care & Research SA de CV
Yucatan, ,
Status
Recruiting
Address
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, ,
Status
Withdrawn
Address
Green City Medical Center
Angeles City, ,
Status
Recruiting
Address
Perpetual Succour Hospital
Cebu City, ,
Status
Recruiting
Address
Davao Doctors Hospital - Medicine
Davao City, ,
Status
Recruiting
Address
Iloilo Doctors Hospital
Iloilo City, ,
Status
Recruiting
Address
Mary Mediatrix Medical Center
Lipa City, ,
Status
Recruiting
Address
Chinese General Hospital & Medical Center
Manila, ,
Status
Recruiting
Address
Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
Quezon City, ,
Status
Recruiting
Address
Ospital Ng Makati
Quezon City, ,
Status
Recruiting
Address
Nova Reuma Spolka Partnerska
Bialystok, ,
Status
Recruiting
Address
Prywatna Praktyka Lekarska prof Pawel Hrycaj
Koscian, ,
Status
Recruiting
Address
Centrum Medyczne Plejady
Krakow, ,
Status
Recruiting
Address
Centrum Nowoczesnych Terapii Dobry Lekarz
Krakow, ,
Status
Recruiting
Address
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, ,
Status
Recruiting
Address
Twoja Przychodnia PCM
Poznan, ,
Status
Recruiting
Address
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, ,
Status
Recruiting
Address
Clinical Best Solutions - Warszawa
Warszawa, ,
Status
Recruiting
Address
Centrul Medical Monza SRL - Arensia Exploratory Medicine
Bucharest, ,
Status
Recruiting
Address
S.C Delta Health Care S.R.L - Ponderas Academic Hospital
Bucuresti, ,
Status
Recruiting
Address
Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie
Bucuresti, ,
Status
Recruiting
Address
Spitalul Clinic "Sf. Maria" - parent
Bucuresti, ,
Status
Recruiting
Address
Spitalul Clinic Colentina - parent
Bucuresti, ,
Status
Recruiting
Address
Sc Medaudio-Optica SRL
Ramnicu Valcea, ,
Status
Recruiting
Address
Institute of Rheumatology- 1
Belgrade, ,
Status
Recruiting
Address
Institute of Rheumatology-1
Belgrade, ,
Status
Recruiting
Address
Institute of Rheumatology
Belgrade, ,
Status
Recruiting
Address
University Clinical Center of Serbia - Clinic of Alergology and Imunology
Belgrade, ,
Status
Recruiting
Address
University Clinical Center Kragujevac
Kragujevac, ,
Status
Recruiting
Address
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
Cape Town, ,
Status
Recruiting
Address
University of Pretoria Clinical Research Unit - Parent
Pretoria, ,
Status
Active, not recruiting
Address
Naidoo, A - Netcare Umhlanga Hospital
Umhlanga, ,
Status
Recruiting
Address
Hospital General de Castellon - Servicio de Reumatologia
Castelló, ,
Status
Recruiting
Address
Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia
La Coruña, ,
Status
Recruiting
Address
Hospital Universitario 12 de Octubre - Servicio de Reumatologia
Madrid, ,
Status
Recruiting
Address
Hospital Regional Universitario de Malaga - Reumatology Dept
Málaga, ,
Status
Recruiting
Address
Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
Santander, ,
Status
Recruiting
Address
Hospital Quironsalud Sagrado Corazon - Reumatologia
Sevilla, ,
Status
Recruiting
Address
Hospital Universitario Dr. Peset - Servicio de Reumatologia
Valencia, ,
Status
Recruiting
Address
Hospital Universitario Rio Hortega - Servicio de Medicina Interna
Valladolid, ,
Status
Recruiting
Address
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, ,
Status
Recruiting
Address
Taipei Veterans General Hospital
Taipei City, ,
Status
Recruiting
Address
Cheng Hsin General Hospital
Taipei, ,