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Clinical Trials in the USA / NCT07332481
Recruiting Phase 3

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

NCT07332481 · tracked via the Priya Life Science USA tracker
Sponsor
EMD Serono Research & Development Institute, Inc.
Phase
Phase 3
Started
2026-03-10
Last updated
2026-09-11

Condition(s) studied

Systemic Lupus Erythematosus (SLE)Cutaneous Lupus Erythematosus (CLE)

Investigational drug(s) / intervention(s)

EnpatoranPlaceboStandard 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 (45)

FacilityCityRegionStatus
Dermatology Research Associates - 300204025 Los Angeles California Recruiting
Cohen Medical Centers Thousand Oaks California Recruiting
GNP Research at Mark Jaffe, MD Cooper City Florida Recruiting
Advance Medical Research Center Miami Florida Recruiting
Diverse Clinical Research LLC Miami Florida Recruiting
D&H National Research Centers, Inc. Tamarac Florida Recruiting
Clinical Research of West Florida, Inc. Tampa Florida Recruiting
Emory University School of Medicine Atlanta Georgia Recruiting
Revival Research Institute, LLC Troy Michigan Recruiting
Allen Arthritis Allen Texas Recruiting
Arthritis and Rheumatology Research Institute PLLC Allen Texas Recruiting
Arthritis Care of Texas Corpus Christi Texas Recruiting
DCC V Plovdiv Sv. Archbishop Luka EOOD Plovdiv Bulgaria Recruiting
Ambulatory for Specialized Medical Help - skin and venereal diseases Sofia Bulgaria Recruiting
CHU Saint Etienne - Hôpital Nord - service de medecine interne Saint-Étienne-de-Montluc Pays de la Loire Region Recruiting
Hopital Tenon - service dermatologie et centre d'allergie Paris France Recruiting
Elbekliniken Buxtehude GmbH - Dermatologie Buxtehude Lower Saxony Recruiting
Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie Berlin Germany Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden Germany Recruiting
Chaim Sheba Medical Center - pt Ramat Gan Israel Recruiting
Azienda USL Toscana Centro - Ospedale Piero Palagi Florence Firenze Recruiting
JCHO Chukyo Hospital - Dept of Dermatology Nagoya Aichi-ken Recruiting
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology Chiba Chiba Recruiting
Hospital of the University of Occupational and Environmental Health - Dept of Dermatology Kitakyushu-shi Fukuoka Recruiting
Fukushima Medical University Hospital - Dept of Rheumatology/Immunology Fukushima Fukushima Recruiting
Sapporo City General Hospital - Dept of Rheumatology/Immunology Sapporo Hokkaido Recruiting
Kobe University Hospital - Dept of Immunology/Rheumatology Kobe Hyōgo Recruiting
Kanazawa University Hospital - Dept of Rheumatology/Immunology Kanazawa Ishikawa-ken Recruiting
Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology Sendai Miyagi Recruiting
The University of Osaka Hospital - Dept of Dermatology Suita-shi Osaka Recruiting
Institute of Science Tokyo Hospital - Dept of Dermatology Bunkyo-ku Tokyo Recruiting
St. Luke's International Hospital - Dept of Immunology/Allergy Chūōku Tokyo-To Recruiting
Centrum Badan Klinicznych JCI Krakow Poland Recruiting
ETG Lublin - ETG NETWORK Sp. z o.o. Lublin Poland Recruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o. Malbork Poland Recruiting
Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej Rzeszów Poland Recruiting
SOMED CR Rzeszów Poland Recruiting
Velocity Zamosc Zamość Poland Recruiting
Futuremeds S R L. Brasov Romania Recruiting
Artromac n.o. - Reumatologicka ambulancia Košice Slovakia Recruiting

+ 5 more sites — see the full list on the official registry below.

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 NCT07332481 on ClinicalTrials.gov ↗ ← All trials in the USA