About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. 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)
2. Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A >= 6
3. Other protocol defined inclusion criteria could apply

Exclusion criteria

1. Autoimmune or rheumatic disease other than SLE or CLE
2. Dermatological diseases other than cutaneous manifestations of SLE or CLE
3. Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
4. Ongoing or active clinically significant viral, bacterial or fungal infection
5. History of uncontrolled seizures or other neurological disorder
6. History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
7. History of malignancy
8. Other protocol defined exclusion criteria could apply

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.