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Clinical Trials in the USA / NCT07355218
Recruiting Phase 3

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

NCT07355218 · tracked via the Priya Life Science USA tracker
Sponsor
EMD Serono Research & Development Institute, Inc.
Phase
Phase 3
Started
2026-04-01
Last updated
2026-09-14

Condition(s) studied

Systematic Lupus ErythematosusCutaneous Lupus Erythematosus

Investigational drug(s) / intervention(s)

Enpatoran →PlaceboStandard of care (SoC)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Inland Rheumatology Clinical Trials, Inc. Upland California Recruiting
Omega Research Debary, LLC DeBary Florida Recruiting
South Florida Rheumatology Hollywood Florida Recruiting
GTL Medical And Research Group Miami Florida Recruiting
Bolanos Clinical Research Pembroke Pines Florida Recruiting
Vantage Clinical Trials Tampa Florida Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
Accurate Clinical Research Inc. - Lake Charles Lake Charles Louisiana Recruiting
Oakland Hills Dermatology Auburn Hills Michigan Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas II, LLC Charlotte North Carolina Recruiting
Superior Clinical Research, LLC Smithfield North Carolina Recruiting
North Texas Center for Clinical Research Frisco Texas Recruiting
Accurate Clinical Research Humble Texas Recruiting
DCC 1 Sevlievo EOOD Sevlievo Bulgaria Recruiting
DCC "Alexandrovska", EOOD Sofia Bulgaria Recruiting
The Medical Arts Health Research Group - 300128547 Kelowna British Columbia Recruiting
The Second Hospital of Hebei Medical University - 300184836 Shijiazhuang Hebei Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Recruiting
Qilu Hospital of Shandong University - 300163463 Jinan Shandong Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
MEDICAL PLUS s.r.o. Uherské Hradiště Czechia Recruiting
Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie Wuppertal North Rhine-Westphalia Recruiting
Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol Leipzig Saxony Recruiting
Tel Aviv Sourasky Medical Center-Derma - 150314762 Tel Aviv Israel Recruiting
Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent Rome Italy Recruiting
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Dip. Medicina - U.O.C. Reumatologia Verona Italy Recruiting
Centrum Medyczne Plejady Kraków Poland Recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Szczecin Poland Recruiting
S.C Neurocity S.R.L Bucharest Romania Recruiting
Kyung Hee University Hospital at Gangdong Seoul Gangwon-do Recruiting
Hospital General de Castellon - Servicio de Reumatologia Castellón Castellón Recruiting
Hospital Universitario La Paz - Internal Medicine Department Madrid Spain Recruiting
Dermatotomi AG Weinfelden Switzerland Recruiting
Kaohsiung Veterans General Hospital - Internal Medicine Kaohsiung City Taiwan Recruiting
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City Taiwan Recruiting

More EMD Serono Research & Development Institute, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07355218 on ClinicalTrials.gov ↗ ← All trials in the USA