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

  • STATUS
    Recruiting
  • End date
    Aug 16, 2024
  • participants needed
    440
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 4 October 2022
corticosteroids
estrogen
lupus
cutaneous lupus

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.

Details
Condition Systemic Lupus Erythematosus
Treatment Placebo, M5049 low dose, M5049 medium dose, M5049 high dose
Clinical Study IdentifierNCT05162586
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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