The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

April 15, 2026 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 [NCT05162586]).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Centro de Investigaciones Medicas Mar del Plata - CIM
      • Buenos Aires, Argentina
        • CINME - Centro de Investigaciones Metabolicas
      • Ciudad Autonoma Buenos Aires, Argentina
        • Buenos Aires Skin
      • Ciudad Autonoma Buenos Aires, Argentina
        • Hospital Militar Central Dr. Cosme Argerich
      • Mar del Plata, Argentina
        • Centro de Investigaciones Medicas Mar del Plata - CIM
      • Mendoza, Argentina
        • Instituto de Reumatologia
      • San Fernando, Argentina
        • Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
      • San Juan, Argentina
        • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
      • San Miguel, Argentina
        • PSORIAHUE-Medicina Interdisciplinar
      • San Miguel, Argentina
        • Centro Dermatologico Schejtman
      • San Miguel de Tucumán, Argentina
        • Centro de Investigaciones Médicas Tucuman
      • San Miguel de Tucumán, Argentina
        • Investigaciones Clínicas Tucumán
  • Australia
      • Clayton, Australia
        • Monash Medical Centre Clayton
      • Woolloongabba, Australia
        • Veracity Clinical Research
  • Brazil
      • Belo Horizonte, Brazil
        • Santa Casa de Misericórdia de Belo Horizonte
      • Cuiabá, Brazil
        • Oncovida - Centro de Onco-Hematologia de Mato Grosso
      • Graça, Brazil
        • Clínica SER da Bahia
      • Juiz de Fora, Brazil
        • CMiP - Centro Mineiro de Pesquisa
      • Moinhos de Vento, Brazil
        • Hospital Moinhos de Vento
      • São José, Brazil
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa
      • São Paulo, Brazil
        • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
  • Bulgaria
      • Haskovo, Bulgaria
        • DCC 'Sveti Georgi' EOOD - Cardiology Office
      • Plovdiv, Bulgaria
        • MC Artmed OOD
      • Sevlievo, Bulgaria
        • DCC 1 Sevlievo EOOD
      • Sofia, Bulgaria
        • Military Medical Academy - MHAT - Sofia
      • Sofia, Bulgaria
        • DCC Focus 5 - MEOH OOD
      • Sofia, Bulgaria
        • UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
      • Sofia, Bulgaria
        • UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
  • Chile
      • Los Lagos, Chile
        • Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
      • Santiago, Chile
        • Centro Medico Prosalud
      • Santiago, Chile
        • BioMedica Research Group - Psicomedica Clinical and Research Group
      • Santiago, Chile
        • CeCim Biocinetic
      • Santiago, Chile
        • Dermacross
      • Santiago, Chile
        • CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
  • China
      • Baotou, China
        • The First Affiliated Hospital of Baotou Medical College
      • Beijing, China
        • Peking Union Medical College Hospital - Beijing Union Medical College Hospital
      • Changchun, China
        • The First Hospital of Jilin University
      • Guangzhou, China
        • Guangdong Provincial People's Hospital
      • Haikou, China
        • Hainan General Hospital
      • Luoyang, China
        • The First Affiliated Hospital of Henan University of Science And Technology
      • Nanchang, China
        • The Second Affiliated Hospital of Nanchang University
      • Nanjing, China
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Shanghai, China
        • Shanghai Skin Disease Hospital
      • Shanghai, China
        • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
      • Shanghai, China
        • Huashan Hospital, Fudan University - Neurology
      • Sichuan, China
        • West China Hospital, Sichuan University
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Tianjin, China
        • Tianjin Medical University General Hospital
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
  • Colombia
      • Barranquilla, Colombia
        • Centro de Investigacion Medico Asistencial S.A.S
      • Bogotá, Colombia
        • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
      • Bucaramanga, Colombia
        • Servimed S.A.S.
      • Medellín, Colombia
        • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
      • Zipaquirá, Colombia
        • Healthy Medical Center
  • Greece
      • Athens, Greece
        • General Hospital of Athens Laiko
      • Thessaloniki, Greece
        • General Hospital Papageorgiou
  • Israel
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center - pt
  • Japan
      • Asahikawa-shi, Japan
        • NHO Asahikawa Medical Center - Dept of Gastroenterology
      • Chiba, Japan
        • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
      • Chūōku, Japan
        • St. Luke's International Hospital - Dept of Immunology/Allergy
      • Hiroshima, Japan
        • Hiroshima University Hospital
      • Kagoshima, Japan
        • Eiraku Clinic - Dept of Rheumatology
      • Kawagoe-shi, Japan
        • Saitama Medical Center - Dept of Rheumatology/Immunology
      • Kita-gun, Japan
        • Kagawa University Hospital - Dept of Immunology/ Rheumatology
      • Sapporo, Japan
        • Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
      • Sendai, Japan
        • Tohoku University Hospital - Dept of Hematology/Immunology
  • Mauritius
      • Quatre Bornes, Mauritius
        • CAP Research Ltd
  • Mexico
      • Cuernavaca, Mexico
        • Consultorio Privado Dr. Miguel Cortes Hernandez
      • Guadalajara, Mexico
        • Centro de Estudios de Investigacion Basica Y Clinica SC
      • Guadalajara, Mexico
        • Diseño y Planeacion en Investigacion Medica S.C.
      • Mexicali, Mexico
        • Centro Medico del Angel
      • Mexico City, Mexico
        • CAIMED Investigacion en salud S.A de C.V.
      • Mexico City, Mexico
        • Clinstile, S.A. de C.V.
      • Monterrey, Mexico
        • Centro Regiomontano de Estudios Clínicos Roma S.C.
      • Mérida, Mexico
        • Medical Care & Research SA de CV
      • México, Mexico
        • Centro de Investigacion Clínica GRAMEL S.C
      • México, Mexico
        • Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas
      • México, Mexico
        • Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B
      • México, Mexico
        • Grupo Medico Camino S.C.
      • Torreón, Mexico
        • CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
  • Moldova
      • Chisinau, Moldova
        • ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
  • Philippines
      • Davao City, Philippines
        • Davao Doctors Hospital - Medicine
      • Iloilo City, Philippines
        • Iloilo Doctors Hospital
      • Lipa City, Philippines
        • Mary Mediatrix Medical Center
      • Makati City, Philippines
        • Ospital ng Makati
      • Manila, Philippines
        • Chinese General Hospital & Medical Center
      • Quezon City, Philippines
        • Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
  • Poland
      • Bialystok, Poland
        • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
      • Kościan, Poland
        • Prywatna Praktyka Lekarska prof Pawel Hrycaj
      • Krakow, Poland
        • Centrum Medyczne Plejady
      • Krakow, Poland
        • Centrum Nowoczesnych Terapii Dobry Lekarz
      • Poznan, Poland
        • Twoja Przychodnia PCM
      • Szczecin, Poland
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o
      • Warsaw, Poland
        • Clinical Best Solutions - Warszawa
  • Romania
      • Bucharest, Romania
        • Centrul Medical Monza SRL - Arensia Exploratory Medicine
      • Bucharest, Romania
        • S.C Delta Health Care S.R.L - Ponderas Academic Hospital
      • Bucharest, Romania
        • Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie
      • Bucharest, Romania
        • Spitalul Clinic "Sf. Maria" - parent
  • Serbia
      • Belgrade, Serbia
        • Institute of Rheumatology
      • Belgrade, Serbia
        • University Clinical Center of Serbia - Clinic of Alergology and Imunology
      • Belgrade, Serbia
        • Institute of Rheumatology - Rheumatology
  • South Africa
      • Cape Town, South Africa
        • Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
      • Pretoria, South Africa
        • University of Pretoria Clinical Research Unit - Parent
      • Umhlanga, South Africa
        • Naidoo, A - Netcare Umhlanga Hospital
  • South Korea
      • Incheon, South Korea
        • Gachon University Gil Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Suwon, South Korea
        • Ajou University Hospital
  • Spain
      • Castelló, Spain
        • Hospital General de Castellon - Servicio de Reumatologia
      • Málaga, Spain
        • Hospital Regional Universitario de Malaga - Reumatology Dept
      • Santander, Spain
        • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
      • Valladolid, Spain
        • Hospital Universitario Rio Hortega - Servicio de Medicina Interna
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • United States
    • California
      • Torrance, California, United States, 90502
        • The Lundquist Institute at Harbor-UCLA Medical Center
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Arthritis And Osteoporosis
      • Miami, Florida, United States, 33135
        • Advance Medical Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Dermatology Group, LLC
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • AA MRC LLC Ahmed Arif Medical Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University - CTMO Parent
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Ramesh C Gupta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M5049 low dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.
Drug: M5049 low dose
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.
Other Names:
  • Enpatoran
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.
Experimental: M5049 medium dose+ Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.
Drug: M5049 medium dose
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.
Other Names:
  • Enpatoran
Experimental: M5049 high dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .
Drug: Placebo
Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.
Drug: M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.
Other Names:
  • Enpatoran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Time Frame: Baseline up to Week 50 (Long Term Extension Part 1)
Baseline up to Week 50 (Long Term Extension Part 1)
Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Time Frame: Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2))
Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2))

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
Time Frame: Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2)
Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

August 12, 2028

Study Completion (Estimated)

August 12, 2028

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS200569_0048
  • 2022-000239-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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