The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

• Status: Not yet recruiting
• Trial end date: 2024-08-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany

Criteria

Inclusion Criteria:

• Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8

• 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

• 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

• 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