A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

{ "ELOWEN-2 Study of Enpatoran for Lupus Skin Manifestations", "This study is testing a drug called enpatoran to see if it can help people with active skin problems from lupus (cutaneous lupus erythematosus), whether or not they also have systemic lupus erythematosus. Participants will receive either enpatoran or a placebo (an inactive pill) twice a day for 24 weeks, along with their usual care. The study aims to see if enpatoran can significantly improve skin lesions, measured by a 70% or more decrease in a score called CLASI-A. You might be able to join if you are between 18 and 75 years old, have a diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE), and have up-to-date vaccinations. The study plans to enroll 202 participants.", "design": "This is a Phase 3 interventional study comparing enpatoran to a placebo, with participants also receiving standard of care. It plans to enroll 202 participants.", "commitments": "You would take enpatoran or a placebo twice daily for 24 weeks. You would have study visits every 4 weeks, with an additional televisit at Week 2, for a total study duration of up to 35 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "The primary outcome is measured at Week 24, and the total study duration is up to 35 weeks.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

Recruiting

PHASE3Ages 18–75InterventionalTreatment

EMD Serono Research & Development Institute, Inc.

~202 participants

Updated 2026-08-17 on ClinicalTrials.gov

What's tested:EnpatoranPlaceboStandard of care (SoC)

At a glance

Recruiting sites

17 of 17 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over At Week 24

Conditions

Systematic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Where it's being run

17 sites across 11 states

Florida5

North Carolina2

Texas2

California1

Indiana1

Louisiana1

Michigan1

British Columbia1

Study leadership

Medical Responsible · STUDY_DIRECTOR · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Who to contact

US Medical Information

[email protected]

888-275-7376

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

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.

Exclusion

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.

What this trial measures

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 BaselineAt Week 24

Trialytics