Study of M5049 in CLE and SLE Participants

• Status: Recruiting
• Trial end date: 2022-03-04
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Criteria

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

• Other protocol defined inclusion criteria could apply

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

• Other protocol defined exclusion criteria could apply