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New pill aims to calm lupus skin flares in major trial

NCT ID NCT07332481

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study tests an experimental pill called enpatoran for people with lupus who have active skin rashes. About 202 participants will receive either the drug or a placebo for 24 weeks, while continuing their usual treatments. The goal is to see if enpatoran can significantly reduce skin disease activity. This is a Phase 3 trial, meaning it is one of the final steps before possible approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 202 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus discoid lupus erythematosus subacute cutaneous lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous lupus erythematosus (CLE) Systemic lupus erythematosus (SLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advance Medical Research Center

    RECRUITING

    Miami, Florida, 33135, United States

  • Allen Arthritis

    RECRUITING

    Allen, Texas, 75013, United States

  • Ambulatory for Specialized Medical Help - skin and venereal diseases

    RECRUITING

    Sofia, 1407, Bulgaria

  • Arthritis Care of Texas

    RECRUITING

    Corpus Christi, Texas, 78415, United States

  • Arthritis and Rheumatology Research Institute PLLC

    RECRUITING

    Allen, Texas, 75013, United States

  • Artromac n.o. - Reumatologicka ambulancia

    RECRUITING

    Košice, 04011, Slovakia

  • Azienda USL Toscana Centro - Ospedale Piero Palagi

    RECRUITING

    Florence, Firenze, 50125, Italy

  • CHU Saint Etienne - Hôpital Nord - service de medecine interne

    RECRUITING

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

  • Centrum Badan Klinicznych JCI

    RECRUITING

    Krakow, 30-348, Poland

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

    RECRUITING

    Malbork, 82-200, Poland

  • Chaim Sheba Medical Center - pt

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie

    RECRUITING

    Berlin, 10117, Germany

  • Chi Mei Medical Center - 300192662

    RECRUITING

    Tainan, 71004, Taiwan

  • China Medical University Hospital

    RECRUITING

    Taichung, 404332, Taiwan

  • Clinical Research of West Florida, Inc.

    RECRUITING

    Tampa, Florida, 33606, United States

  • Cohen Medical Centers

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Complejo Hospitalario Universitario de Santiago - Dermatology Unit

    RECRUITING

    Santiago de Compostela, La Coruña, 15706, Spain

  • D&H National Research Centers, Inc.

    RECRUITING

    Tamarac, Florida, 33321, United States

  • DCC V Plovdiv Sv. Archbishop Luka EOOD

    RECRUITING

    Plovdiv, 4023, Bulgaria

  • Dermatology Research Associates - 300204025

    RECRUITING

    Los Angeles, California, 90045, United States

  • Diverse Clinical Research LLC

    RECRUITING

    Miami, Florida, 33175, United States

  • ETG Lublin - ETG NETWORK Sp. z o.o.

    RECRUITING

    Lublin, 20-412, Poland

  • Elbekliniken Buxtehude GmbH - Dermatologie

    RECRUITING

    Buxtehude, Lower Saxony, 21614, Germany

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Fukushima Medical University Hospital - Dept of Rheumatology/Immunology

    RECRUITING

    Fukushima, Fukushima, 960-1295, Japan

  • Futuremeds S R L.

    RECRUITING

    Brasov, 500299, Romania

  • GNP Research at Mark Jaffe, MD

    RECRUITING

    Cooper City, Florida, 33024, United States

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Hopital Tenon - service dermatologie et centre d'allergie

    RECRUITING

    Paris, 75020, France

  • Hospital of the University of Occupational and Environmental Health - Dept of Dermatology

    RECRUITING

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • Institute of Science Tokyo Hospital - Dept of Dermatology

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • JCHO Chukyo Hospital - Dept of Dermatology

    RECRUITING

    Nagoya, Aichi-ken, 457-8510, Japan

  • Kanazawa University Hospital - Dept of Rheumatology/Immunology

    RECRUITING

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie

    RECRUITING

    Sankt Gallen, 9000, Switzerland

  • Kobe University Hospital - Dept of Immunology/Rheumatology

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

    RECRUITING

    Chiba, Chiba, 260-8712, Japan

  • Revival Research Institute, LLC

    RECRUITING

    Troy, Michigan, 48084, United States

  • SOMED CR

    RECRUITING

    Rzeszów, 35-309, Poland

  • Sapporo City General Hospital - Dept of Rheumatology/Immunology

    RECRUITING

    Sapporo, Hokkaido, 060-8604, Japan

  • St. Luke's International Hospital - Dept of Immunology/Allergy

    RECRUITING

    Chūōku, Tokyo-To, 104-8560, Japan

  • The University of Osaka Hospital - Dept of Dermatology

    RECRUITING

    Suita-shi, Osaka, 565-0871, Japan

  • Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology

    RECRUITING

    Sendai, Miyagi, 983-8512, Japan

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej

    RECRUITING

    Rzeszów, 35-055, Poland

  • Velocity Zamosc

    RECRUITING

    Zamość, 22-400, Poland

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Other studies related to the condition(s) this trial covers.