The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
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)
2 other identifiers
interventional
379
22 countries
122
Brief 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 (MS200569\_0003 \[NCT05162586\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2022
Longer than P75 for phase_2
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedStudy Start
First participant enrolled
September 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2028
April 16, 2026
April 1, 2026
5.9 years
September 12, 2022
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
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)
Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2))
Secondary Outcomes (1)
Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2)
Study Arms (3)
M5049 low dose + Placebo
EXPERIMENTALParticipants 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.
M5049 medium dose+ Placebo
EXPERIMENTALParticipants 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.
M5049 high dose + Placebo
EXPERIMENTALParticipants 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 .
Interventions
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.
Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511, United States
Advance Medical Research Center
Miami, Florida, 33135, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46250, United States
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Ohio State University - CTMO Parent
Columbus, Ohio, 43210, United States
Ramesh C Gupta, MD
Memphis, Tennessee, 38119, United States
Centro de Investigaciones Medicas Mar del Plata - CIM
Buenos Aires, Argentina
CINME - Centro De Investigaciones Metabolicas
Buenos Aires, Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, Argentina
Hospital Militar Central Dr. Cosme Argerich
Ciudad Autonoma Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata - CIM
Mar del Plata, Argentina
Instituto de Reumatologia
Mendoza, Argentina
Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
San Fernando, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, Argentina
Centro Dermatologico Schejtman
San Miguel, Argentina
PSORIAHUE-Medicina Interdisciplinar
San Miguel, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Argentina
Monash Medical Centre Clayton
Clayton, Australia
Veracity Clinical Research
Woolloongabba, Australia
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá, Brazil
Clínica SER da Bahia
Graça, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Brazil
Hospital Moinhos de Vento
Moinhos de Vento, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa
São José, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, Brazil
DCC 'Sveti Georgi' EOOD - Cardiology Office
Haskovo, Bulgaria
MC Artmed OOD
Plovdiv, Bulgaria
DCC 1 Sevlievo EOOD
Sevlievo, Bulgaria
DCC Focus 5 - MEOH OOD
Sofia, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
Sofia, Bulgaria
Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
Los Lagos, Chile
BioMedica Research Group - Psicomedica Clinical and Research Group
Santiago, Chile
CeCim Biocinetic
Santiago, Chile
Centro Medico Prosalud
Santiago, Chile
CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
Santiago, Chile
Dermacross
Santiago, Chile
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Peking Union Medical College Hospital - Beijing Union Medical College Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Guangdong Provincial People's Hospital
Guangzhou, China
Hainan General Hospital
Haikou, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, China
Huashan Hospital, Fudan University - Neurology
Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, China
Shanghai Skin Disease Hospital
Shanghai, China
West China Hospital, Sichuan University
Sichuan, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Tianjin Medical University General Hospital
Tianjin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
Bogotá, Colombia
Servimed S.A.S.
Bucaramanga, Colombia
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Medellín, Colombia
Healthy Medical Center
Zipaquirá, Colombia
General Hospital of Athens Laiko
Athens, Greece
General Hospital Papageorgiou
Thessaloniki, Greece
Chaim Sheba Medical Center - pt
Ramat Gan, Israel
NHO Asahikawa Medical Center - Dept of Gastroenterology
Asahikawa-shi, Japan
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
Chiba, Japan
St. Luke's International Hospital - Dept of Immunology/Allergy
Chūōku, Japan
Hiroshima University Hospital
Hiroshima, Japan
Eiraku Clinic - Dept of Rheumatology
Kagoshima, Japan
Saitama Medical Center - Dept of Rheumatology/Immunology
Kawagoe-shi, Japan
Kagawa University Hospital - Dept of Immunology/ Rheumatology
Kita-gun, Japan
Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
Sapporo, Japan
Tohoku University Hospital - Dept of Hematology/Immunology
Sendai, Japan
CAP Research Ltd
Quatre Bornes, Mauritius
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca, Mexico
Centro de Estudios de Investigacion Basica y Clinica SC
Guadalajara, Mexico
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara, Mexico
Diseño y Planeacion en Investigacion Medica S.C.
Guadalajara, Mexico
Centro Medico del Angel
Mexicali, Mexico
CAIMED Investigacion en salud S.A de C.V.
Mexico City, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico
Medical Care & Research SA de CV
Mérida, 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.
México, Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Mexico
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
Torreón, Mexico
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, Moldova
Davao Doctors Hospital - Medicine
Davao City, Philippines
Iloilo Doctors Hospital
Iloilo City, Philippines
Mary Mediatrix Medical Center
Lipa City, Philippines
Ospital Ng Makati
Makati City, Philippines
Chinese General Hospital & Medical Center
Manila, Philippines
Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
Quezon City, Philippines
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Poland
Prywatna Praktyka Lekarska prof Pawel Hrycaj
Kościan, Poland
Centrum Medyczne Plejady
Krakow, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz
Krakow, Poland
Twoja Przychodnia PCM
Poznan, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o
Szczecin, Poland
Clinical Best Solutions - Warszawa
Warsaw, Poland
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
Bucharest, Romania
Institute of Rheumatology - Rheumatology
Belgrade, Serbia
Institute of Rheumatology
Belgrade, Serbia
University Clinical Center of Serbia - Clinic of Alergology and Imunology
Belgrade, Serbia
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
Cape Town, South Africa
University of Pretoria Clinical Research Unit - Parent
Pretoria, South Africa
Naidoo, A - Netcare Umhlanga Hospital
Umhlanga, South Africa
Gachon University Gil Medical Center
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital General de Castellon - Servicio de Reumatologia
Castelló, Spain
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
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 14, 2022
Study Start
September 16, 2022
Primary Completion (Estimated)
August 12, 2028
Study Completion (Estimated)
August 12, 2028
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- 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
- 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.
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