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New pill could ease lupus skin rashes in major trial

NCT ID NCT07355218

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 7 times

Summary

This study tests a drug called enpatoran for people with lupus who have active skin rashes or lesions. About 202 participants will take either enpatoran or a placebo twice daily for 24 weeks, alongside their usual treatments. The goal is to see if the drug can significantly improve skin symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enpatoran (a drug taken as a tablet twice daily)
What this could lead to
If it works, this could offer a new treatment option for people with lupus-related skin rashes and lesions, potentially reducing their severity.
What could go wrong
This is an early Phase 3 trial with only 202 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are still being studied.

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

Apr 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 systemic lupus erythematosus

As listed by the trial registrant

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

Cutaneous lupus erythematosus Systematic lupus erythematosus

How to take part

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

  1. The places running it

    36 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

  • Accurate Clinical Research

    RECRUITING

    Humble, Texas, 77346, United States

  • Accurate Clinical Research Inc. - Lake Charles

    RECRUITING

    Lake Charles, Louisiana, 70605, United States

  • Arthritis and Osteoporosis Consultants of the Carolinas II, LLC

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Dip. Medicina - U.O.C. Reumatologia

    RECRUITING

    Verona, 37126, Italy

  • Bolanos Clinical Research

    RECRUITING

    Pembroke Pines, Florida, 33026, United States

  • Centrum Medyczne Plejady

    RECRUITING

    Kraków, 30-363, Poland

  • DCC "Alexandrovska", EOOD

    RECRUITING

    Sofia, 1431, Bulgaria

  • DCC 1 Sevlievo EOOD

    RECRUITING

    Sevlievo, 5400, Bulgaria

  • Dawes Fretzin Clinical Research Group, LLC

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Dermatotomi AG

    RECRUITING

    Weinfelden, 8570, Switzerland

  • GTL Medical And Research Group

    RECRUITING

    Miami, Florida, 33173, United States

  • Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hospital General de Castellon - Servicio de Reumatologia

    RECRUITING

    Castellón, Castellón, 12004, Spain

  • Hospital Universitario La Paz - Internal Medicine Department

    RECRUITING

    Madrid, 28046, Spain

  • Inland Rheumatology Clinical Trials, Inc.

    RECRUITING

    Upland, California, 91786, United States

  • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent

    RECRUITING

    Rome, 00144, Italy

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Veterans General Hospital - Internal Medicine

    RECRUITING

    Kaohsiung City, 81362, Taiwan

  • Kyung Hee University Hospital at Gangdong

    RECRUITING

    Seoul, Gangwon-do, 134-727, South Korea

  • MEDICAL PLUS s.r.o.

    RECRUITING

    Uherské Hradiště, 686 01, Czechia

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • North Texas Center for Clinical Research

    RECRUITING

    Frisco, Texas, 75034, United States

  • Oakland Hills Dermatology

    RECRUITING

    Auburn Hills, Michigan, 48326, United States

  • Omega Research Debary, LLC

    RECRUITING

    DeBary, Florida, 32713, United States

  • Qilu Hospital of Shandong University - 300163463

    RECRUITING

    Jinan, Shandong, 250012, China

  • S.C Neurocity S.R.L

    RECRUITING

    Bucharest, 040215, Romania

  • South Florida Rheumatology

    RECRUITING

    Hollywood, Florida, 33026, United States

  • Superior Clinical Research, LLC

    RECRUITING

    Smithfield, North Carolina, 27577, United States

  • Tel Aviv Sourasky Medical Center-Derma - 150314762

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471000, China

  • The Medical Arts Health Research Group - 300128547

    RECRUITING

    Kelowna, British Columbia, V1Y 4Z5, Canada

  • The Second Hospital of Hebei Medical University - 300184836

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

    RECRUITING

    Szczecin, 71- 500, Poland

  • Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Vantage Clinical Trials

    RECRUITING

    Tampa, Florida, 33603, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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