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Study of M5049 in CLE and SLE Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of M5049 in CLE and SLE Participants

A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care

NCT04647708•Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Active systemic lupus erythematosus (SLE) with a Cutaneous lupus erythematosus disease area and activity index (CLASI-A) greater than or equal to \[\>= \] 6 and/or at least one active SLE clinical manifestation according to Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
•Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A \>= 6

Exclusion Criteria

•Autoimmune or rheumatic disease other than SLE or CLE
•Dermatological diseases other than cutaneous manifestations of SLE or CLE
•Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
•Ongoing or active clinically significant viral, bacterial or fungal infection
•History of uncontrolled seizures or other neurological disorder
•History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
•History of malignancy

Locations (12)

Medical center Medconsult Pleven OOD

Pleven, Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, Bulgaria

Military Medical Academy - MHAT - Sofia

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

SocraTec R&D GmbH

Erfurt, Germany

Fraunhofer ITMP (Fraunhofer Institute for Translational Medicine and Pharmacology)

Frankfurt, Germany

ARENSIA Exploratory Medicine Phase I Unit, Clinical Republican Hospital

Chisinau, Moldova

PHI University Clinic of Rheumatology Skopje

Skopje, North Macedonia

Hospital Universitario Nuestra Señora de Valme

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Key Dates

Start Date

December 16, 2020

Primary Completion Date

December 19, 2023

Completion Date

December 19, 2023

Last Updated

February 21, 2024

Enrollment

ACTUAL participants

Conditions

Systemic Lupus ErythematosusCutaneous Lupus Erythematosus

Interventions

M5049

DRUG

M5049

DRUG

M5049

DRUG

Placebo

DRUG

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RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of M5049 in CLE and SLE Participants

Inclusion Criteria

Exclusion Criteria

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