Recruiting
Phase 3

Enpatoran

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT07355218

Conditions

Systematic Lupus Erythematosus

Cutaneous Lupus Erythematosus

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

Systematic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Study ID

NCT07355218

Start date

Apr 1, 2026

Status verified date

Aug, 2026

Completion date

May 25, 2029

Anticipated

Primary completion date

May 25, 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

US Medical Information

888-275-7376eMediUSA@emdserono.com

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

Inland Rheumatology Clinical Trials, Inc.

Recruiting

Upland, California, United States, 91786

Omega Research Debary, LLC

Recruiting

DeBary, Florida, United States, 32713

South Florida Rheumatology

Recruiting

Hollywood, Florida, United States, 33026

GTL Medical And Research Group

Recruiting

Miami, Florida, United States, 33173

Bolanos Clinical Research

Recruiting

Pembroke Pines, Florida, United States, 33026

Vantage Clinical Trials

Recruiting

Tampa, Florida, United States, 33603

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Accurate Clinical Research Inc. - Lake Charles

Recruiting

Lake Charles, Louisiana, United States, 70605

Oakland Hills Dermatology

Recruiting

Auburn Hills, Michigan, United States, 48326

Arthritis and Osteoporosis Consultants of the Carolinas II, LLC

Recruiting

Charlotte, North Carolina, United States, 28207

Superior Clinical Research, LLC

Recruiting

Smithfield, North Carolina, United States, 27577

North Texas Center for Clinical Research

Recruiting

Frisco, Texas, United States, 75034

Accurate Clinical Research

Recruiting

Humble, Texas, United States, 77346

The Medical Arts Health Research Group - 300128547

Recruiting

Kelowna, British Columbia, Canada, V1Y 4Z5

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Toll-like Receptor 7
  • Toll-like Receptor 8
  • Adults
  • SLE
  • CLE
  • Lupus
  • Discoid lupus erythematosus
  • Subacute cutaneous lupus erythematosus
  • M5049
  • Enpatoran
  • Cutaneous manifestations
  • Lupus erythematosus
  • Acute cutaneous lupus erythematosus
  • Systemic lupus erythematosus
  • Interferon gene signature

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-08-17.