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NCT07332481PHASE3Recruiting

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

EMD Serono Research & Development Institute, Inc.

Start Date

3/10/2026

Completion Date

5/24/2029

Summary

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria * Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory. * Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE). * Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit. * Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE. For participants with SLE: * Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria. * Participants with disease duration (cutaneous disease and, where applicable, SLE) of \>= 6 months from time of diagnosis to Screening. * Participants with CLASI-A score \>= 8 at Screening and Day 1 visits. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria * Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE. * Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation. * Participants with drug-induced lupus (SLE or CLE). * Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed). * Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation. * Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures. * Other protocol-defined exclusion criteria may apply.

Interventions

DRUG

Enpatoran

DRUG

Placebo

DRUG

Standard of care (SoC)

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Conditions

Systemic Lupus Erythematosus (SLE)Cutaneous Lupus Erythematosus (CLE)

Locations

Dermatology Research Associates - 300204025

Los Angeles, California 90045

United States

Cohen Medical Centers

Thousand Oaks, California 91360

United States

GNP Research at Mark Jaffe, MD

Cooper City, Florida 33024

United States

Advance Medical Research Center

Miami, Florida 33135

United States

Diverse Clinical Research LLC

Miami, Florida 33175

United States

D&H National Research Centers, Inc.

Tamarac, Florida 33321

United States

Clinical Research of West Florida, Inc.

Tampa, Florida 33606

United States

Emory University School of Medicine

Atlanta, Georgia 30303

United States

Revival Research Institute, LLC

Troy, Michigan 48084

United States

Allen Arthritis

Allen, Texas 75013

United States

Arthritis and Rheumatology Research Institute PLLC

Allen, Texas 75013

United States

Arthritis Care of Texas

Corpus Christi, Texas 78415

United States

Sapporo City General Hospital - Dept of Rheumatology/Immunology

Sapporo, Hokkaido 060-8604

Japan