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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000239-21 | EudraCT Number |
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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M5049 low dose + Placebo | Experimental | 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. |
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| M5049 medium dose+ Placebo | Experimental | 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 | Experimental | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5049 low dose | Drug | Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: 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 (Long Term Extension Part 1) | |
| Part 2: 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 194 (LTE Part 1 and LTE Prolongation Part 2)) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected | Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Lundquist Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States | ||
| Bay Area Arthritis and Osteoporosis |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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| M5049 medium dose | Drug | Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks. |
|
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| M5049 high dose | Drug | Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks. |
|
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| Placebo | Drug | Participants will receive M5049 matching placebo orally, BID for up to 194 weeks. |
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| Brandon |
| Florida |
| 33511 |
| United States |
| Advance Medical Research Center | Miami | Florida | 33135 | United States |
| Dawes Fretzin Dermatology Group, LLC | Indianapolis | Indiana | 46250 | United States |
| AA MRC LLC Ahmed Arif Medical Research Center | Grand Blanc | Michigan | 48439 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Ohio State University - CTMO Parent | Columbus | Ohio | 43210 | United States |
| Ramesh C Gupta, MD | Memphis | Tennessee | 38119 | United States |
| Centro de Investigaciones Medicas Mar del Plata - CIM | Buenos Aires | Argentina |
| CINME - Centro De Investigaciones Metabolicas | Buenos Aires | Argentina |
| Buenos Aires Skin | Ciudad Autonoma Buenos Aires | Argentina |
| Hospital Militar Central Dr. Cosme Argerich | Ciudad Autonoma Buenos Aires | Argentina |
| Centro de Investigaciones Medicas Mar del Plata - CIM | Mar del Plata | Argentina |
| Instituto de Reumatologia | Mendoza | 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 |
| Centro Dermatologico Schejtman | San Miguel | Argentina |
| PSORIAHUE-Medicina Interdisciplinar | San Miguel | Argentina |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Argentina |
| Investigaciones Clinicas Tucuman | San Miguel de Tucumán | Argentina |
| Monash Medical Centre Clayton | Clayton | Australia |
| Veracity Clinical Research | Woolloongabba | Australia |
| Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | Brazil |
| Oncovida - Centro de Onco-Hematologia de Mato Grosso | Cuiabá | Brazil |
| Clínica SER da Bahia | Graça | Brazil |
| CMiP - Centro Mineiro de Pesquisa | Juiz de Fora | Brazil |
| Hospital Moinhos de Vento | Moinhos de Vento | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa | São José | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos | São Paulo | Brazil |
| DCC 'Sveti Georgi' EOOD - Cardiology Office | Haskovo | 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 | Bulgaria |
| Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno | Los Lagos | Chile |
| BioMedica Research Group - Psicomedica Clinical and Research Group | Santiago | Chile |
| CeCim Biocinetic | Santiago | Chile |
| Centro Medico Prosalud | Santiago | Chile |
| CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda | Santiago | Chile |
| Dermacross | Santiago | Chile |
| 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 |
| Guangdong Provincial People's Hospital | Guangzhou | China |
| Hainan General Hospital | Haikou | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China |
| The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | China |
| Huashan Hospital, Fudan University - Neurology | Shanghai | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch | Shanghai | China |
| Shanghai Skin Disease Hospital | Shanghai | China |
| West China Hospital, Sichuan University | Sichuan | China |
| The First Affiliated Hospital of Soochow University | Suzhou | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| Centro de Investigacion Medico Asistencial S.A.S | Barranquilla | Colombia |
| Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM | Bogotá | Colombia |
| Servimed S.A.S. | Bucaramanga | Colombia |
| Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS | Medellín | Colombia |
| Healthy Medical Center | Zipaquirá | Colombia |
| General Hospital of Athens Laiko | Athens | Greece |
| General Hospital Papageorgiou | Thessaloniki | Greece |
| Chaim Sheba Medical Center - pt | Ramat Gan | Israel |
| NHO Asahikawa Medical Center - Dept of Gastroenterology | Asahikawa-shi | Japan |
| NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology | Chiba | Japan |
| St. Luke's International Hospital - Dept of Immunology/Allergy | Chūōku | Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Eiraku Clinic - Dept of Rheumatology | Kagoshima | Japan |
| Saitama Medical Center - Dept of Rheumatology/Immunology | Kawagoe-shi | Japan |
| Kagawa University Hospital - Dept of Immunology/ Rheumatology | Kita-gun | Japan |
| Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog | Sapporo | Japan |
| Tohoku University Hospital - Dept of Hematology/Immunology | Sendai | Japan |
| CAP Research Ltd | Quatre Bornes | Mauritius |
| Consultorio Privado Dr. Miguel Cortes Hernandez | Cuernavaca | Mexico |
| Centro de Estudios de Investigacion Basica y Clinica SC | Guadalajara | 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 |
| CAIMED Investigacion en salud S.A de C.V. | Mexico City | Mexico |
| Clinstile, S.A. de C.V. | Mexico City | Mexico |
| Medical Care & Research SA de CV | Mérida | Mexico |
| Centro de Investigacion Clínica GRAMEL S.C | México | Mexico |
| Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas | México | Mexico |
| Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B | México | Mexico |
| Grupo Medico Camino S.C. | México | Mexico |
| Centro Regiomontano de Estudios Clínicos Roma S.C. | Monterrey | Mexico |
| CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni | Torreón | Mexico |
| ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga" | Chisinau | Moldova |
| Davao Doctors Hospital - Medicine | Davao City | Philippines |
| Iloilo Doctors Hospital | Iloilo City | Philippines |
| Mary Mediatrix Medical Center | Lipa City | Philippines |
| Ospital Ng Makati | Makati City | Philippines |
| Chinese General Hospital & Medical Center | Manila | Philippines |
| 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 |
| Prywatna Praktyka Lekarska prof Pawel Hrycaj | Kościan | Poland |
| Centrum Medyczne Plejady | Krakow | Poland |
| Centrum Nowoczesnych Terapii Dobry Lekarz | Krakow | Poland |
| Twoja Przychodnia PCM | Poznan | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o | Szczecin | Poland |
| Clinical Best Solutions - Warszawa | Warsaw | Poland |
| Centrul Medical Monza SRL - Arensia Exploratory Medicine | Bucharest | Romania |
| S.C Delta Health Care S.R.L - Ponderas Academic Hospital | Bucharest | Romania |
| Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie | Bucharest | Romania |
| Spitalul Clinic "Sf. Maria" - parent | Bucharest | Romania |
| Institute of Rheumatology - Rheumatology | Belgrade | Serbia |
| Institute of Rheumatology | Belgrade | Serbia |
| University Clinical Center of Serbia - Clinic of Alergology and Imunology | Belgrade | Serbia |
| Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat | Cape Town | South Africa |
| University of Pretoria Clinical Research Unit - Parent | Pretoria | South Africa |
| Naidoo, A - Netcare Umhlanga Hospital | Umhlanga | South Africa |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Hospital General de Castellon - Servicio de Reumatologia | Castelló | Spain |
| Hospital Regional Universitario de Malaga - Reumatology Dept | Málaga | Spain |
| Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia | Santander | Spain |
| Hospital Universitario Rio Hortega - Servicio de Medicina Interna | Valladolid | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008179 | Lupus Erythematosus, Discoid |
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
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