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New lupus drug enpatoran tested for long-term safety

NCT ID NCT05540327

Disease control Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This study looks at the long-term safety and effectiveness of enpatoran, an experimental drug for lupus. About 379 people who completed a previous 24-week study will take different doses of enpatoran or a placebo for up to 194 weeks. The goal is to see if the drug is safe and helps control lupus over a longer period.

What this could mean

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

Active substance
Enpatoran (M5049)
What this could lead to
If successful, this could provide a new long-term treatment option to control lupus symptoms and reduce flare-ups.
What could go wrong
This is a Phase 2 extension study, so it is still early. The drug may not prove safe or effective over the long term, and side effects are possible.

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

379 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Aug 2028

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 76 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: * Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study * Have a Body Mass Index (BMI) within the less than or equal to (\<=) 40 kilograms per meter square (inclusive) at Screening * Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1 * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participants who experienced serious event(s) related to the study intervention during the WILLOW study * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation * Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 \[(SARS-CoV-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization * Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24 * Participation in any other investigational drug study after the WILLOW study Week 24 * 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

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439, 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

  • CIEC- Centro Internacional de Estudios Clinicos - 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

  • CeCim Biocinetic

    Santiago, Chile

  • Centro Dermatologico Schejtman

    San Miguel, Argentina

  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

    Medellín, Colombia

  • Centro Medico Prosalud

    Santiago, Chile

  • Centro Medico del Angel

    Mexicali, Mexico

  • Centro Regiomontano de Estudios Clínicos Roma S.C.

    Monterrey, 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 SAS. CIREEM

    Bogotá, Colombia

  • Centro de Investigaciones Medicas Mar del Plata - CIM

    Buenos Aires, Argentina

  • 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

  • Chinese General Hospital & Medical Center

    Manila, Philippines

  • Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno

    Los Lagos, Chile

  • Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas

    México, Mexico

  • Clinical Best Solutions - Warszawa

    Warsaw, Poland

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico

  • Clínica SER da Bahia

    Graça, Brazil

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca, Mexico

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

    México, Mexico

  • DCC 'Sveti Georgi' EOOD - Cardiology Office

    Haskovo, Bulgaria

  • DCC 1 Sevlievo EOOD

    Sevlievo, Bulgaria

  • DCC Focus 5 - MEOH OOD

    Sofia, Bulgaria

  • Davao Doctors Hospital - Medicine

    Davao City, Philippines

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dermacross

    Santiago, Chile

  • Diseno y Planeacion en Investigacion Medica S.C.

    Guadalajara, Mexico

  • Diseño y Planeacion en Investigacion Medica S.C.

    Guadalajara, Mexico

  • Eiraku Clinic - Dept of Rheumatology

    Kagoshima, Japan

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

    Quezon City, Philippines

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa

    São José, Brazil

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • General Hospital Papageorgiou

    Thessaloniki, Greece

  • General Hospital of Athens Laiko

    Athens, Greece

  • Grupo Medico Camino S.C.

    México, Mexico

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Hainan General Hospital

    Haikou, China

  • Healthy Medical Center

    Zipaquirá, Colombia

  • Hiroshima University Hospital

    Hiroshima, Japan

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

    Sapporo, Japan

  • Hospital General de Castellon - Servicio de Reumatologia

    Castelló, Spain

  • Hospital Militar Central Dr. Cosme Argerich

    Ciudad Autonoma Buenos Aires, Argentina

  • Hospital Moinhos de Vento

    Moinhos de Vento, Brazil

  • Hospital Regional Universitario de Malaga - Reumatology Dept

    Málaga, Spain

  • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia

    Santander, Spain

  • Hospital Universitario Rio Hortega - Servicio de Medicina Interna

    Valladolid, Spain

  • Huashan Hospital, Fudan University - Neurology

    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 - Rheumatology

    Belgrade, Serbia

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

    San Fernando, Argentina

  • Instituto de Reumatologia

    Mendoza, Argentina

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Argentina

  • Kagawa University Hospital - Dept of Immunology/ Rheumatology

    Kita-gun, 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

    Mérida, Mexico

  • Military Medical Academy - MHAT - Sofia

    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

  • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, Poland

  • Ohio State University - CTMO Parent

    Columbus, Ohio, 43210, United States

  • Oncovida - Centro de Onco-Hematologia de Mato Grosso

    Cuiabá, Brazil

  • Ospital Ng Makati

    Makati City, Philippines

  • PSORIAHUE-Medicina Interdisciplinar

    San Miguel, Argentina

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

    Beijing, China

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Kościan, Poland

  • Ramesh C Gupta, MD

    Memphis, Tennessee, 38119, United States

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

    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

  • Seoul National University Hospital

    Seoul, South Korea

  • Servimed S.A.S.

    Bucaramanga, Colombia

  • Shanghai Skin Disease Hospital

    Shanghai, China

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

    Bucharest, Romania

  • Spitalul Clinic "Sf. Maria" - parent

    Bucharest, Romania

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

    Chūōku, Japan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, 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 Hospital of Jilin University

    Changchun, China

  • The Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Tohoku University Hospital - Dept of Hematology/Immunology

    Sendai, Japan

  • Twoja Przychodnia PCM

    Poznan, Poland

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

    Szczecin, Poland

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

    Sofia, Bulgaria

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

    Sofia, Bulgaria

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

    Belgrade, Serbia

  • 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

    Sichuan, China

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