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Systemic Lupus ErythematosusPhase 2NCT05540327

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

A Phase 2 study testing M5049 low dose, M5049 medium dose and M5049 high dose in people with Systemic Lupus Erythematosus, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 122 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 76 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
M5049 low dose, M5049 medium dose and M5049 high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
122 sitesin 22 countries
Study dates
16 Sep 2022to 12 Aug 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

122 sites in 22 countries.

122 sites in 22 countries

China15 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou

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

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Hainan General Hospital

    Haikou

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

    Luoyang

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing

  • Huashan Hospital, Fudan University - Neurology

    Shanghai

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

    Shanghai

  • Shanghai Skin Disease Hospital

    Shanghai

  • West China Hospital, Sichuan University

    Sichuan

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Medical University General Hospital

    Tianjin

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

Other trials in China

Mexico14 sites

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca

  • Centro de Estudios de Investigacion Basica y Clinica SC

    Guadalajara

  • Diseno y Planeacion en Investigacion Medica S.C.

    Guadalajara

  • Diseño y Planeacion en Investigacion Medica S.C.

    Guadalajara

  • Medical Care & Research SA de CV

    Mérida

  • Centro Medico del Angel

    Mexicali

  • Centro de Investigacion Clínica GRAMEL S.C

    México

  • Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas

    México

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

    México

  • Grupo Medico Camino S.C.

    México

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

    Mexico City

  • Clinstile, S.A. de C.V.

    Mexico City

  • Centro Regiomontano de Estudios Clínicos Roma S.C.

    Monterrey

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

    Torreón

Other trials in Mexico

Argentina12 sites

  • Centro de Investigaciones Medicas Mar del Plata - CIM

    Buenos Aires

  • CINME - Centro De Investigaciones Metabolicas

    Buenos Aires

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires

  • Hospital Militar Central Dr. Cosme Argerich

    Ciudad Autonoma Buenos Aires

  • Centro de Investigaciones Medicas Mar del Plata - CIM

    Mar del Plata

  • Instituto de Reumatologia

    Mendoza

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

    San Fernando

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

    San Juan

  • Centro Dermatologico Schejtman

    San Miguel

  • PSORIAHUE-Medicina Interdisciplinar

    San Miguel

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán

Other trials in Argentina

Japan9 sites

  • NHO Asahikawa Medical Center - Dept of Gastroenterology

    Asahikawa-shi

  • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

    Chiba

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

    Chūōku

  • Hiroshima University Hospital

    Hiroshima

  • Eiraku Clinic - Dept of Rheumatology

    Kagoshima

  • Saitama Medical Center - Dept of Rheumatology/Immunology

    Kawagoe-shi

  • Kagawa University Hospital - Dept of Immunology/ Rheumatology

    Kita-gun

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

    Sapporo

  • Tohoku University Hospital - Dept of Hematology/Immunology

    Sendai

Other trials in Japan

United States8 sites

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511

  • Ohio State University - CTMO Parent

    Columbus, Ohio, 43210

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana, 46250

  • Ramesh C Gupta, MD

    Memphis, Tennessee, 38119

  • Advance Medical Research Center

    Miami, Florida, 33135

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • The Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

Brazil7 sites

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte

  • Oncovida - Centro de Onco-Hematologia de Mato Grosso

    Cuiabá

  • Clínica SER da Bahia

    Graça

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora

  • Hospital Moinhos de Vento

    Moinhos de Vento

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

    São José

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo

Other trials in Brazil

Bulgaria7 sites

  • DCC 'Sveti Georgi' EOOD - Cardiology Office

    Haskovo

  • MC Artmed OOD

    Plovdiv

  • DCC 1 Sevlievo EOOD

    Sevlievo

  • DCC Focus 5 - MEOH OOD

    Sofia

  • Military Medical Academy - MHAT - Sofia

    Sofia

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

    Sofia

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

    Sofia

Other trials in Bulgaria

Poland7 sites

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

    Bialystok

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Kościan

  • Centrum Medyczne Plejady

    Krakow

  • Centrum Nowoczesnych Terapii Dobry Lekarz

    Krakow

  • Twoja Przychodnia PCM

    Poznan

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

    Szczecin

  • Clinical Best Solutions - Warszawa

    Warsaw

Other trials in Poland

Chile6 sites

  • Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno

    Los Lagos

  • BioMedica Research Group - Psicomedica Clinical and Research Group

    Santiago

  • CeCim Biocinetic

    Santiago

  • Centro Medico Prosalud

    Santiago

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

    Santiago

  • Dermacross

    Santiago

Other trials in Chile

Philippines6 sites

  • Davao Doctors Hospital - Medicine

    Davao City

  • Iloilo Doctors Hospital

    Iloilo City

  • Mary Mediatrix Medical Center

    Lipa City

  • Ospital Ng Makati

    Makati City

  • Chinese General Hospital & Medical Center

    Manila

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

    Quezon City

Other trials in Philippines

Colombia5 sites

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla

  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

    Bogotá

  • Servimed S.A.S.

    Bucaramanga

  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

    Medellín

  • Healthy Medical Center

    Zipaquirá

Other trials in Colombia

Romania4 sites

  • Centrul Medical Monza SRL - Arensia Exploratory Medicine

    Bucharest

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

    Bucharest

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

    Bucharest

  • Spitalul Clinic "Sf. Maria" - parent

    Bucharest

Other trials in Romania

Spain4 sites

  • Hospital General de Castellon - Servicio de Reumatologia

    Castelló

  • Hospital Regional Universitario de Malaga - Reumatology Dept

    Málaga

  • Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia

    Santander

  • Hospital Universitario Rio Hortega - Servicio de Medicina Interna

    Valladolid

Other trials in Spain

Serbia3 sites

  • Institute of Rheumatology - Rheumatology

    Belgrade

  • Institute of Rheumatology

    Belgrade

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

    Belgrade

Other trials in Serbia

South Africa3 sites

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

    Cape Town

  • University of Pretoria Clinical Research Unit - Parent

    Pretoria

  • Naidoo, A - Netcare Umhlanga Hospital

    Umhlanga

Other trials in South Africa

South Korea3 sites

  • Gachon University Gil Medical Center

    Incheon

  • Seoul National University Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Australia2 sites

  • Monash Medical Centre Clayton

    Clayton

  • Veracity Clinical Research

    Woolloongabba

Other trials in Australia

Greece2 sites

  • General Hospital of Athens Laiko

    Athens

  • General Hospital Papageorgiou

    Thessaloniki

Other trials in Greece

Taiwan2 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

Israel1 site

  • Chaim Sheba Medical Center - pt

    Ramat Gan

Other trials in Israel

Mauritius1 site

  • CAP Research Ltd

    Quatre Bornes

Other trials in Mauritius

Moldova1 site

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

    Chisinau

Other trials in Moldova

About this study

Official title: 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]).

Being tested
M5049 low dose, M5049 medium dose, M5049 high dose, Placebo
Keywords
Toll-like Receptor 7, Toll-like Receptor 8, WILLOW, Adults, SLE, CLE, Lupus, Discoid lupus erythematosus, Subacute cutaneous lupus erythematosus, M5049, Enpatoran, LTE
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Lupus Erythematosus, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M5049 low doseDrug

    Also called Enpatoran

    Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.

  • M5049 medium doseDrug

    Also called Enpatoran

    Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.

  • M5049 high doseDrug

    Also called Enpatoran

    Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.

  • PlaceboDrug

    Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.

Study groups in NCT05540327
Study groupRoleWhat they receive
M5049 low dose + PlaceboExperimentalParticipants 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.
Receives: Drug: M5049 low dose; Drug: Placebo
M5049 medium dose+ PlaceboExperimentalParticipants 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.
Receives: Drug: M5049 medium dose; Drug: Placebo
M5049 high dose + PlaceboExperimentalParticipants 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 .
Receives: Drug: M5049 high dose; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)

    Measured: Baseline up to Week 50 (Long Term Extension Part 1)

  2. Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)

    Measured: Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2))

Secondary outcomes (1)

  1. Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected

    Measured: Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start16 Sep 2022
  3. Primary completion12 Aug 2028 (estimated)
  4. Study completion12 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05540327
Sponsor's protocol ID
MS200569_0048
Other IDs
2022-000239-21, CTR20222533, jRCT2071220084
Status last verified
Sep 2026
First submitted
12 Sep 2022
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD supporting publicly available results will be evaluated for sharing.

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