Study of M5049 in CLE and SLE Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

December 19, 2023

Study Completion Date

December 19, 2023

Conditions
Systemic Lupus ErythematosusCutaneous Lupus Erythematosus
Interventions
DRUG

M5049

Participants will receive low oral dose of M5049, twice daily in Part A.

DRUG

M5049

Participants will receive ascending oral dose of M5049, twice daily in Part A.

DRUG

M5049

Participants will receive high oral dose of M5049, twice daily in Part B.

DRUG

Placebo

Participants will receive placebo matched to M5049.

Trial Locations (12)

Unknown

Medical center Medconsult Pleven OOD, Pleven

Medical Center-1-Sevlievo EOOD, Sevlievo

Military Medical Academy - MHAT - Sofia, Sofia

"UMHAT Sv. Ivan Rilski, EAD", Sofia

SocraTec R&D GmbH, Erfurt

Fraunhofer ITMP (Fraunhofer Institute for Translational Medicine and Pharmacology), Frankfurt

ARENSIA Exploratory Medicine Phase I Unit, Clinical Republican Hospital, Chisinau

PHI University Clinic of Rheumatology Skopje, Skopje

Hospital Universitario Nuestra Señora de Valme, Seville

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario Rio Hortega - Servicio de Medicina Interna, Valladolid

"Medical Center of Limited Liability Company Harmoniya krasy, Department of clinical trials", Kyiv

All Listed Sponsors
lead

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT04647708 - Study of M5049 in CLE and SLE Participants | Biotech Hunter | Biotech Hunter