Clinical trial NCT05540327: The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Toll-like Receptor 7
Toll-like Receptor 8
WILLOW
Adults
SLE
CLE
Lupus
Discoid lupus erythematosus
Subacute cutaneous lupus erythematosus
M5049
Enpatoran
LTE
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[NCT05162586\]).


Eligibility criteria: Inclusion Criteria:

* Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
* Have a Body Mass Index (BMI) within the \>= 40 kilograms per meter square (inclusive) at Screening
* 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

Primary outcomes:
measure: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
timeFrame: Baseline up to Week 50
Secondary outcomes:
measure: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
timeFrame: Baseline up to Week 50
measure: Percent Change from WILLOW Study Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Weeks 0, 2, 4, 12, 24, 36 and 48
timeFrame: Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
measure: Change from WILLOW Study Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Weeks 0, 2, 4, 12, 24, 36 and 48
timeFrame: Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
measure: Number of Participants With Based Composite Lupus Assessment (BICLA) Response
timeFrame: At Weeks 24 and 48
measure: Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response
timeFrame: At Weeks 24 and 48
Other outcomes:
Locations:
city: Torrance
country: United States
facility: The Lundquist Institute at Harbor-UCLA Medical Center
state: California
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group, LLC
state: Indiana
city: Grand Blanc
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University - CTMO Parent
state: Ohio
city: Memphis
country: United States
facility: Ramesh C Gupta, MD
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata - CIM
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Skin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Militar Central Dr. Cosme Argerich
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CINME - Centro De Investigaciones Metabolicas
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata - CIM
city: Mendoza
country: Argentina
facility: Instituto de Reumatologia
city: San Fernando
country: Argentina
facility: Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clinicas Tucuman
city: San Miguel
country: Argentina
facility: Centro Dermatologico Schejtman
city: San Miguel
country: Argentina
facility: PSORIAHUE-Medicina Interdisciplinar
city: Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
city: Cuiabá
country: Brazil
facility: Oncovida - Centro de Onco-Hematologia de Mato Grosso
city: Graca
country: Brazil
facility: Clínica SER da Bahia
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa
city: Moinhos de Vento
country: Brazil
facility: Hospital Moinhos de Vento
city: Sao Jose
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - CIP - Centro Integrado de Pesquisa
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
city: Haskovo
country: Bulgaria
facility: DCC 'Sveti Georgi' EOOD - Cardiology Office
city: Plovdiv
country: Bulgaria
facility: MC Artmed OOD
city: Sevlievo
country: Bulgaria
facility: DCC 1 Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: DCC Focus 5 - MEOH OOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
city: Los Lagos
country: Chile
facility: Clinica Alemana de Osorno - Corporacion de Beneficencia Osorno
city: Santiago
country: Chile
facility: BioMedica Research Group - Psicomedica Clinical and Research Group
city: Santiago
country: Chile
facility: CeCim Biocinetic
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
city: Santiago
country: Chile
facility: Dermacross
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
city: Beijing
country: China
facility: Peking Union Medical College Hospital - Beijing Union Medical College Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Haikou
country: China
facility: Hainan General Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University - Neurology
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
city: Sichuan
country: China
facility: West China Hospital, Sichuan University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial S.A.S
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
city: Medellin
country: Colombia
facility: Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
city: Zipaquirá
country: Colombia
facility: Healthy Medical Center
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Thessaloniki
country: Greece
facility: General Hospital Papageorgiou
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center - pt
city: Asahikawa-shi
country: Japan
facility: NHO Asahikawa Medical Center - Dept of Gastroenterology
city: Chiba-shi
country: Japan
facility: NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital - Dept of Immunology/Allergy
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima-shi
country: Japan
facility: Eiraku Clinic - Dept of Rheumatology
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center - Dept of Rheumatology/Immunology
city: Kita-gun
country: Japan
facility: Kagawa University Hospital - Dept of Immunology/ Rheumatology
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital - Dept of Hematology/Immunology
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Quatre Bornes
country: Mauritius
facility: CAP Research Ltd
city: Ciudad de México
country: Mexico
facility: CAIMED Investigacion en salud S.A de C.V.
city: Ciudad de México
country: Mexico
facility: Clinstile, S.A. de C.V.
city: Cuernavaca
country: Mexico
facility: Consultorio Privado Dr. Miguel Cortes Hernandez
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica SC
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica S.C.
city: Guadalajara
country: Mexico
facility: Diseño y Planeacion en Investigacion Medica S.C.
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Mexicali
country: Mexico
facility: Centro Medico del Angel
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
city: Mexico
country: Mexico
facility: Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas
city: Mexico
country: Mexico
facility: Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B
city: Mexico
country: Mexico
facility: Grupo Medico Camino S.C.
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clínicos Roma S.C.
city: Torreon
country: Mexico
facility: CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
city: Chisinau
country: Moldova, Republic of
facility: ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
city: Davao City
country: Philippines
facility: Davao Doctors Hospital - Medicine
city: Iloilo City
country: Philippines
facility: Iloilo Doctors Hospital
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
city: Makati City
country: Philippines
facility: Ospital Ng Makati
city: Manila
country: Philippines
facility: Chinese General Hospital & Medical Center
city: Quezon City
country: Philippines
facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
city: Bialystok
country: Poland
facility: Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
city: Koscian
country: Poland
facility: Prywatna Praktyka Lekarska prof Pawel Hrycaj
city: Krakow
country: Poland
facility: Centrum Nowoczesnych Terapii Dobry Lekarz
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Poznan
country: Poland
facility: Twoja Przychodnia PCM
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o
city: Warszawa
country: Poland
facility: Clinical Best Solutions - Warszawa
city: Bucharest
country: Romania
facility: Centrul Medical Monza SRL - Arensia Exploratory Medicine
city: Bucuresti
country: Romania
facility: S.C Delta Health Care S.R.L - Ponderas Academic Hospital
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sf. Maria" - parent
city: Belgrade
country: Serbia
facility: Institute of Rheumatology - Rheumatology
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia - Clinic of Alergology and Imunology
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
city: Pretoria
country: South Africa
facility: University of Pretoria Clinical Research Unit - Parent
city: Umhlanga
country: South Africa
facility: Naidoo, A - Netcare Umhlanga Hospital
city: Castello
country: Spain
facility: Hospital General de Castellon - Servicio de Reumatologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Reumatology Dept
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega - Servicio de Medicina Interna
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: