Recruiting
Phase 3

Enpatoran

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT07332481

Conditions

Systemic Lupus Erythematosus (SLE)

Cutaneous Lupus Erythematosus (CLE)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Enpatoran

Placebo

Standard of care (SoC)

Study Details

Brief 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Cutaneous Lupus Erythematosus (CLE)

Study ID

NCT07332481

Start date

Mar 10, 2026

Status verified date

Aug, 2026

Completion date

May 24, 2029

Anticipated

Primary completion date

May 24, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enpatoran

placebo comparator: Placebo

Interventions

Enpatoran

Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.

Placebo

Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.

Standard of care (SoC)

Participants will receive Investigator-recommended SoC.

Primary outcome measure

  • Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline [ Time Frame: At Week 24 ]

Central Contacts and Locations

Central contacts

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

Dermatology Research Associates - 300204025

Recruiting

Los Angeles, California, United States, 90045

Cohen Medical Centers

Recruiting

Thousand Oaks, California, United States, 91360

GNP Research at Mark Jaffe, MD

Recruiting

Cooper City, Florida, United States, 33024

Advance Medical Research Center

Recruiting

Miami, Florida, United States, 33135

Diverse Clinical Research LLC

Recruiting

Miami, Florida, United States, 33175

D&H National Research Centers, Inc.

Recruiting

Tamarac, Florida, United States, 33321

Clinical Research of West Florida, Inc.

Recruiting

Tampa, Florida, United States, 33606

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30303

Revival Research Institute, LLC

Recruiting

Troy, Michigan, United States, 48084

Allen Arthritis

Recruiting

Allen, Texas, United States, 75013

Arthritis and Rheumatology Research Institute PLLC

Recruiting

Allen, Texas, United States, 75013

Arthritis Care of Texas

Recruiting

Corpus Christi, Texas, United States, 78415

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Toll-like Receptor 7
  • Toll-like Receptor 8
  • Adults
  • SLE
  • CLE
  • Lupus
  • Discoid lupus erythematosus (DLE)
  • Subacute Cutaneous Lupus Erythematosus (SCLE)
  • M5049
  • Enpatoran
  • Cutaneous manifestations
  • Lupus erythematosus
  • Acute cutaneous lupus erythematosus (ACLE)
  • Interferon gene signature

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-08-14.