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

Study Purpose

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran 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 Enpatoran is not available through an expanded access program.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05162586
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	EMD Serono Research & Development Institute, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Responsible
Principal Investigator Affiliation	EMD Serono Research & Development Institute, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Greece, Israel, Japan, Korea, Republic of, Mauritius, Mexico, Moldova, Republic of, Philippines, Poland, Romania, Serbia, South Africa, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus
Study Website:	View Trial Website

Arms & Interventions

Arms

Placebo Comparator: Cohort A: Placebo

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.

Experimental: Cohort A: Enpatoran low dose

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.

Experimental: Cohort A: Enpatoran medium dose

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.

Experimental: Cohort A: Enpatoran high dose

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.

Placebo Comparator: Cohort B (Part 1 + Part 2): Placebo

Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .

Experimental: Cohort B (Part 1 + Part 2): Enpatoran high dose

Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.

Experimental: Cohort B (Part 2): Enpatoran low dose

Experimental: Cohort B (Part 2): Enpatoran medium dose

Interventions

Drug: - Enpatoran low dose

Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.

Drug: - Enpatoran medium dose

Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.

Drug: - Enpatoran high dose

Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.

Drug: - Placebo

Participants will receive placebo matched to Enpatoran up to 24 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Torrance, California

Status

Recruiting

Address

The Lundquist Institute at Harbor-UCLA Medical Center

Torrance, California, 90509

Site Contact

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