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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)

In brief

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.

Key facts

Study ID

NCT07332481

Run by

EMD Serono Research & Development Institute, Inc.

People needed

202

Starts

2026-03-10

Expected to finish

2029-05-24

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dermatology Research Associates - 300204025 — Los Angeles, California, United States (enrolling)
• Cohen Medical Centers — Thousand Oaks, California, United States (enrolling)
• GNP Research at Mark Jaffe, MD — Cooper City, Florida, United States (enrolling)
• Advance Medical Research Center — Miami, Florida, United States (enrolling)
• Diverse Clinical Research LLC — Miami, Florida, United States (enrolling)
• D&H National Research Centers, Inc. — Tamarac, Florida, United States (enrolling)
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• Revival Research Institute, LLC — Troy, Michigan, United States (enrolling)
• Allen Arthritis — Allen, Texas, United States (enrolling)
• Arthritis and Rheumatology Research Institute PLLC — Allen, Texas, United States (enrolling)
• Arthritis Care of Texas — Corpus Christi, Texas, United States (enrolling)
• Sapporo City General Hospital - Dept of Rheumatology/Immunology — Sapporo, Hokkaido, Japan (enrolling)

Full record on ClinicalTrials.gov

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