About the study

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered M5049 over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks M5049 is not available through an expanded access program.

Who can take part?

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

Inclusion criteria

1. Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
2. Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
3. Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
4. 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

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How to apply

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