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New lupus pill shows promise in Mid-Stage trial

NCT ID NCT05162586

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested an experimental drug called enpatoran in 456 people with lupus, a chronic autoimmune disease. Participants took either a low, medium, or high dose of enpatoran or a placebo for 24 weeks. The goal was to see if the drug safely reduces skin and overall disease activity. Results will help decide if larger studies are warranted.

What this could mean

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

Active substance
Enpatoran (also called M5049), taken as a tablet by mouth
What this could lead to
If it works, enpatoran could offer a new oral option to help control lupus symptoms and reduce disease flares.
What could go wrong
This is a mid-stage trial with a placebo group, so results may show no benefit or only modest effects. Side effects are possible, and the drug is not yet proven safe or effective.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

456 people

The number who actually took part.

Started

Mar 2022

Finished

Nov 2024

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: * Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) \>= 8 * Active SLE with presence of: CLASI-A \>= 8 and BILAG 2004 1B, C, D (that is \[i.e.\], No BILAG 2004 A and No BILAG 2004 \>= 2B) or BILAG 2004 \>= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI \>= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI \>= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A \>= 8 * Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Autoimmune or rheumatic disease other than SLE or CLE * Dermatological diseases other than cutaneous manifestations of SLE or CLE * Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder * Ongoing or active clinically significant viral, bacterial, or fungal infection * History of uncontrolled seizures or other neurological disorder * History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus * History of malignancy * Other protocol defined exclusion criteria could 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.

Systemic lupus erythematosus

Contacts and locations

Locations

  • "Andreas Syggros" Hospital - Department of Dermatology

    Athens, Greece

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439, United States

  • Across the Life Span

    Smithfield, North Carolina, 27577, United States

  • Advance Medical Research Center

    Miami, Florida, 33135, United States

  • Ajou University Hospital

    Suwon, South Korea

  • Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat

    Cape Town, South Africa

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511, United States

  • BioMedica Research Group - Psicomedica Clinical and Research Group

    Santiago, Chile

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires, Argentina

  • CAIMED Investigacion en salud S.A de C.V.

    Mexico City, Mexico

  • CAP Research Ltd

    Quatre Bornes, Mauritius

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, Brazil

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    San Juan, Argentina

  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.

    Curitiba, Brazil

  • CIEC - Centro Internacional de Estudios Clínicos - Valenzuela Y Compania Ltda

    Santiago, Chile

  • CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni

    Torreón, Mexico

  • CINME - Centro De Investigaciones Metabolicas

    Buenos Aires, Argentina

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Brazil

  • CPCLIN - Centro de Pesquisas Clínicas Ltda.

    São Paulo, Brazil

  • CeCim Biocinetic

    Santiago, Chile

  • Centro Dermatologico Schejtman

    Ciudad Autonoma Buenos Aires, Argentina

  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

    Medellín, Colombia

  • Centro Medico Prosalud

    Santiago, Chile

  • Centro Medico del Angel

    Mexicali, Mexico

  • Centro de Estudios de Investigacion Basica y Clinica SC

    Guadalajara, Mexico

  • Centro de Investigacion Clínica GRAMEL S.C

    México, Mexico

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, Colombia

  • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.

    Bogotá, Colombia

  • Centro de Investigaciones Medicas Mar del Plata - CIM

    Mar del Plata, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Argentina

  • Centrul Medical Monza SRL - Arensia Exploratory Medicine

    Bucharest, Romania

  • Centrum Medyczne Plejady

    Krakow, Poland

  • Centrum Nowoczesnych Terapii Dobry Lekarz

    Krakow, Poland

  • Chaim Sheba Medical Center - pt

    Ramat Gan, Israel

  • Charisma Medical and Research Center

    Miami Lakes, Florida, 33014, United States

  • Cheng Hsin General Hospital

    Taipei, Taiwan

  • Chinese General Hospital & Medical Center

    Manila, Philippines

  • Citer, Centro de Investigación Y Tratamiento de Las Enfermedades Reumaticas Sa de Cv

    México, Mexico

  • Clinical Best Solutions - Warszawa

    Warsaw, Poland

  • Clinstile, S.A. de C.V.

    México, Mexico

  • Clínica Alemana de Osorno

    Osorno, Chile

  • Clínica SER da Bahia

    Salvador, Brazil

  • Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia

    A Coruña, Spain

  • Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista

    Cuernavaca, Mexico

  • Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B

    México, Mexico

  • D&H Tamarac Research Center, LLC

    Tamarac, Florida, 33321, United States

  • DCC "Alexandrovska", EOOD

    Sofia, Bulgaria

  • DCC 'Sveti Georgi' EOOD - Cardiology Office

    Haskovo, Bulgaria

  • Davao Doctors Hospital - Medicine

    Davao City, Philippines

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana, 46256, United States

  • Dermacross

    Santiago, Chile

  • Ehime University Hospital - Dept of Immunology/Rheumatology

    Toon-shi, Japan

  • Eiraku Clinic - Dept of Rheumatology

    Kagoshima, Japan

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health

    Quezon City, Philippines

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa

    São José do Rio Preto, Brazil

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • General Hospital Papageorgiou

    Thessaloniki, Greece

  • General Hospital of Athens Laiko

    Athens, Greece

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, Greece

  • Grupo Medico Camino S.C.

    México, Mexico

  • Guangdong Provincial People's Hospital - Oncology

    Guangzhou, China

  • HMD Research, LLC

    Orlando, Florida, 32819, United States

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Brazil

  • Hainan General Hospital

    Haikou, China

  • Healthy Medical Center

    Zipaquirá, Colombia

  • Hiroshima University Hospital - Dept of Rheumatology/Immunology

    Hiroshima, Japan

  • Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog

    Sapporo, Japan

  • Hospital Bruno Born

    Lajeado, Brazil

  • Hospital General de Castellon - Servicio de Reumatologia

    Castelló, Spain

  • Hospital Militar Central Dr. Cosme Argerich

    Ciudad Autonoma Buenos Aires, Argentina

  • Hospital Moinhos de Vento

    Porto Alegre, Brazil

  • Hospital Quironsalud Sagrado Corazon - Reumatologia

    Seville, Spain

  • Hospital Regional Universitario de Malaga - Reumatology Dept

    Málaga, Spain

  • Hospital Universitario 12 de Octubre - Servicio de Reumatologia

    Madrid, Spain

  • Hospital Universitario Dr. Peset - Servicio de Reumatologia

    Valencia, Spain

  • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia

    Santander, Spain

  • Hospital Universitario Rio Hortega - Servicio de Medicina Interna

    Valladolid, Spain

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    Nanjing, China

  • Huashan Hospital, Fudan University

    Shanghai, China

  • ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"

    Chisinau, Moldova

  • Iloilo Doctors Hospital

    Iloilo City, Philippines

  • Institute of Rheumatology

    Belgrade, Serbia

  • Institute of Rheumatology- 1

    Belgrade, Serbia

  • Institute of Rheumatology-1

    Belgrade, Serbia

  • Instituto Medico de alta Complejidad San Isidro S.A (IMAC)

    San Fernando, Argentina

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, Argentina

  • Instituto de Reumatologia

    Mendoza, Argentina

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Argentina

  • Kagawa University Hospital - Dept of Immunology/ Rheumatology

    Kita-gun, Japan

  • Kanazawa University Hospital - Dept of Rheumatology/Immunology

    Kanazawa, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • MC Artmed OOD

    Plovdiv, Bulgaria

  • Mary Mediatrix Medical Center

    Lipa City, Philippines

  • Medical Care & Research SA de CV

    Yucatán, Mexico

  • Medical Center-1-Sevlievo EOOD

    Sevlievo, Bulgaria

  • Military Medical Academy - MHAT - Sofia - Department of Rheumatology

    Sofia, Bulgaria

  • Monash Medical Centre Clayton

    Clayton, Australia

  • NHO Asahikawa Medical Center - Dept of Gastroenterology

    Asahikawa-shi, Japan

  • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

    Chiba, Japan

  • Naidoo, A - Netcare Umhlanga Hospital

    Umhlanga, South Africa

  • New Horizon Research Center, Inc

    Miami, Florida, 33165, United States

  • Nova Reuma Spolka Partnerska

    Bialystok, Poland

  • Ohio State University - CTMO Parent

    Columbus, Ohio, 43215, United States

  • Oncovida - Centro de Onco-Hematologia de Mato Grosso

    Cuiabá, Brazil

  • Ospital Ng Makati

    Quezon City, Philippines

  • PSORIAHUE-Medicina Interdisciplinar

    San Miguel, Argentina

  • Peking Union Medical College Hospital - Beijing Union Medical College Hospital

    Beijing, China

  • Perpetual Succour Hospital

    Cebu City, Philippines

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Kościan, Poland

  • Pusan National University Hospital

    Busan, South Korea

  • RNA America Health Sciences

    Sugar Hill, Georgia, 30518, United States

  • Ramesh C Gupta, MD - Memphis, TN

    Memphis, Tennessee, 38119, United States

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, China

  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, China

  • S.C Delta Health Care S.R.L - Ponderas Academic Hospital

    Bucharest, Romania

  • Saitama Medical Center - Dept of Rheumatology/Immunology

    Kawagoe-shi, Japan

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, Brazil

  • Sc Medaudio-Optica SRL

    Râmnicu Vâlcea, Romania

  • Seoul National University Hospital

    Seoul, South Korea

  • Servimed S.A.S.

    Bucaramanga, Colombia

  • Shanghai Skin Disease Hospital

    Shanghai, China

  • Skin and Venereal Diseases' Hospital

    Thessaloniki, Greece

  • Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie

    Bucharest, Romania

  • Spitalul Clinic "Sf. Maria" - parent

    Bucharest, Romania

  • Spitalul Clinic Colentina - parent

    Bucharest, Romania

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

    Chūōku, Japan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The 2nd Xiangya Hospital of Central South University

    Changsha, China

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, China

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, China

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

    Luoyang, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, China

  • The First Hospital of Jilin University

    Changchun, China

  • The Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California, 90509, United States

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Toho University Ohashi Medical Center - Dept of Immunology/Rheumatology

    Meguro-ku, Japan

  • Tohoku University Hospital - Dept of Hematology/Immunology

    Sendai, Japan

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, Poland

  • Twoja Przychodnia PCM

    Poznan, Poland

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, Poland

  • UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology

    Sofia, Bulgaria

  • University Clinical Center Kragujevac

    Kragujevac, Serbia

  • University Clinical Center of Serbia - Clinic of Alergology and Imunology

    Belgrade, Serbia

  • University Hospital of Patra

    Pátrai, Greece

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pretoria Clinical Research Unit - Parent

    Pretoria, South Africa

  • Veracity Clinical Research

    Woolloongabba, Australia

  • West China Hospital, Sichuan University

    Chengdu, China

  • Westmead Hospital - SUPERSEDED

    Westmead, Australia

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