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

RecruitingPhase 3

A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)

Who can join

Ages 18 to 75 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: EMD Serono Research & Development Institute, Inc. · Participants: 202 · Started: Apr 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07355218

Locations in the U.S.

CaliforniaInland Rheumatology Clinical Trials, Inc., Upland
FloridaOmega Research Debary, LLC, DeBary
South Florida Rheumatology, Hollywood
GTL Medical And Research Group, Miami
Bolanos Clinical Research, Pembroke Pines
Vantage Clinical Trials, Tampa
IndianaDawes Fretzin Clinical Research Group, LLC, Indianapolis
LouisianaAccurate Clinical Research Inc. - Lake Charles, Lake Charles
MichiganOakland Hills Dermatology, Auburn Hills
North CarolinaArthritis and Osteoporosis Consultants of the Carolinas II, LLC, Charlotte
Superior Clinical Research, LLC, Smithfield
TexasNorth Texas Center for Clinical Research, Frisco
Accurate Clinical Research, Humble

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.