A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
EMD Serono Research & Development Institute, Inc. · with Merck KGaA, Darmstadt, Germany · NCT07332481
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 202
- US sites recruiting
- 12
- Study start
- March 10, 2026
- Record last updated
- October 6, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Enpatoran; Placebo; Standard of care (SoC)
Conditions: Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Dermatology Research Associates - 300204025
Los Angeles, CA 90045
Cohen Medical Centers
Thousand Oaks, CA 91360
GNP Research at Mark Jaffe, MD
Cooper City, FL 33024
Advance Medical Research Center
Miami, FL 33135
Diverse Clinical Research LLC
Miami, FL 33175
D&H National Research Centers, Inc.
Tamarac, FL 33321
Clinical Research of West Florida, Inc.
Tampa, FL 33606
Emory University School of Medicine
Atlanta, GA 30303
Revival Research Institute, LLC
Troy, MI 48084
Allen Arthritis
Allen, TX 75013
Arthritis and Rheumatology Research Institute PLLC
Allen, TX 75013
Arthritis Care of Texas
Corpus Christi, TX 78415
Study contacts (from the official record)
- Communication Center · +49 6151 72 5200 · service@emdgroup.com