Systemic Lupus Erythematosus Clinical Trial
Official title:
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)
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]).
Status | Recruiting |
Enrollment | 532 |
Est. completion date | April 15, 2025 |
Est. primary completion date | April 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 76 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Centro de Investigaciones Medicas Mar del Plata - CIM | Buenos Aires | |
Argentina | Buenos Aires Skin | Ciudad Autonoma Buenos Aires | |
Argentina | CINME - Centro De Investigaciones Metabolicas | Ciudad Autonoma de Buenos Aires | |
Argentina | Centro de Investigaciones Medicas Mar del Plata - CIM | Mar del Plata | |
Argentina | Instituto Medico de alta Complejidad San Isidro S.A (IMAC) | San Fernando | |
Argentina | CER San Juan Centro Polivalente de Asistencia e Inv. Clinica | San Juan | |
Argentina | PSORIAHUE-Medicina Interdisciplinar | San Miguel | |
Argentina | Investigaciones Clinicas Tucuman | San Miguel de Tucuman | |
Argentina | Centro de Investigaciones Medicas Tucuman | Tucuman | |
Australia | Monash Medical Centre Clayton | Clayton | |
Bulgaria | MC Artmed OOD | Plovdiv | |
Bulgaria | DCC 1 Sevlievo EOOD | Sevlievo | |
Bulgaria | DCC Focus 5 - MEOH OOD | Sofia | |
Bulgaria | Military Medical Academy - MHAT - Sofia | Sofia | |
Bulgaria | UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology | Sofia | |
Bulgaria | UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology | Sofia | |
Chile | BioMedica Research Group - Psicomedica Clinical and Research Group | Santiago | |
Chile | Centro Medico Prosalud | Santiago | |
Chile | CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda | Santiago | |
China | The First Affiliated Hospital of Baotou Medical College | Baotou | |
China | Peking Union Medical College Hospital - Beijing Union Medical College Hospital | Beijing | |
China | The First Hospital of Jilin University | Changchun | |
China | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | |
China | The Second Affiliated Hospital of Nanchang University | Nanchang | |
China | West China Hospital, Sichuan University | Sichuan | |
China | Tianjin Medical University General Hospital | Tianjin | |
Colombia | Centro de Investigacion Medico Asistencial S.A.S | Barranquilla | |
Colombia | Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM | Bogotá | |
Colombia | Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS | Medellin | |
Colombia | Healthy Medical Center | Zipaquirá | |
Greece | General Hospital Papageorgiou | Thessaloniki | |
Japan | St. Luke's International Hospital - Dept of Immunology/Allergy | Chuo-ku | |
Japan | Eiraku Clinic - Dept of Rheumatology | Kagoshima-shi | |
Japan | Kagawa University Hospital - Dept of Immunology/ Rheumatology | Kita-gun | |
Japan | Tohoku University Hospital - Dept of Hematology/Immunology | Sendai-shi | |
Korea, Republic of | Ajou University Hospital | Suwon | |
Mauritius | CAP Research Ltd | Quatre Bornes | |
Mexico | CAIMED Investigacion en salud S.A de C.V. | Ciudad de México | |
Mexico | Clinstile, S.A. de C.V. | Ciudad de México | |
Mexico | Consultorio Privado Dr. Miguel Cortes Hernandez | Cuernavaca | |
Mexico | Diseno y Planeacion en Investigacion Medica S.C. | Guadalajara | |
Mexico | Diseño y Planeacion en Investigacion Medica S.C. | Guadalajara | |
Mexico | Centro Medico del Angel | Mexicali | |
Mexico | Centro de Investigacion Clínica GRAMEL S.C | Mexico | |
Mexico | Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas | Mexico | |
Mexico | Centro Regiomontano de Estudios Clínicos Roma S.C. | Monterrey | |
Mexico | CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni | Torreon | |
Moldova, Republic of | ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga" | Chisinau | |
Philippines | Davao Doctors Hospital - Medicine | Davao City | |
Philippines | Iloilo Doctors Hospital | Iloilo City | |
Philippines | Ospital Ng Makati | Makati City | |
Poland | Nova Reuma Domyslawska i Rusilowicz, Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty | Bialystok | |
Poland | Prywatna Praktyka Lekarska prof Pawel Hrycaj | Koscian | |
Poland | Centrum Nowoczesnych Terapii Dobry Lekarz | Krakow | |
Poland | Centrum Medyczne Plejady | Kraków | |
Poland | Twoja Przychodnia PCM | Poznan | |
Serbia | Institute of Rheumatology | Belgrade | |
Serbia | Institute of Rheumatology | Belgrade | |
Serbia | 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 | |
South Africa | Naidoo, A - Netcare Umhlanga Hospital | Umhlanga | |
Spain | Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia | Santander | |
Spain | Hospital Universitario Rio Hortega - Servicio de Medicina Interna | Valladolid | |
United States | AA MRC LLC Ahmed Arif Medical Research Center | Grand Blanc | Michigan |
United States | Dawes Fretzin Dermatology Group, LLC | Indianapolis | Indiana |
United States | Ramesh C Gupta, MD | Memphis | Tennessee |
United States | Advance Medical Research Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
United States, Argentina, Australia, Bulgaria, Chile, China, Colombia, Greece, Japan, Korea, Republic of, Mauritius, Mexico, Moldova, Republic of, Philippines, Poland, Serbia, South Africa, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected | Baseline up to Week 50 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Number of Participants With Based Composite Lupus Assessment (BICLA) Response | At Weeks 24 and 48 | ||
Secondary | Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response | At Weeks 24 and 48 |
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