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

Systemic Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540327
• Other study ID #: MS200569_0048
• Secondary ID: 2022-000239-21
• Status: Recruiting
• Phase: Phase 2
• Start date: September 16, 2022
• Est. completion date: April 15, 2025

Study information

• Verified date: February 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: Communication Center
• Phone: +49 6151 72 5200
• Email: service[@]emdgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (MS200569_0003 [NCT05162586]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 532
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• M5049 low dose
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 48 weeks.
• M5049 medium dose
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.
• M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.
• Placebo
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
• M5049 very high dose
Participants will receive film-coated tablets of M5049 at a very high dose orally, BID for up to 48 weeks.

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Medicas Mar del Plata - CIM	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires
Argentina	CINME - Centro De Investigaciones Metabolicas	Ciudad Autonoma de Buenos Aires
Argentina	Centro de Investigaciones Medicas Mar del Plata - CIM	Mar del Plata
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	PSORIAHUE-Medicina Interdisciplinar	San Miguel
Argentina	Investigaciones Clinicas Tucuman	San Miguel de Tucuman
Argentina	Centro de Investigaciones Medicas Tucuman	Tucuman
Australia	Monash Medical Centre Clayton	Clayton
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
Chile	BioMedica Research Group - Psicomedica Clinical and Research Group	Santiago
Chile	Centro Medico Prosalud	Santiago
Chile	CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda	Santiago
China	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	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	West China Hospital, Sichuan University	Sichuan
China	Tianjin Medical University General Hospital	Tianjin
Colombia	Centro de Investigacion Medico Asistencial S.A.S	Barranquilla
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM	Bogotá
Colombia	Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS	Medellin
Colombia	Healthy Medical Center	Zipaquirá
Greece	General Hospital Papageorgiou	Thessaloniki
Japan	St. Luke's International Hospital - Dept of Immunology/Allergy	Chuo-ku
Japan	Eiraku Clinic - Dept of Rheumatology	Kagoshima-shi
Japan	Kagawa University Hospital - Dept of Immunology/ Rheumatology	Kita-gun
Japan	Tohoku University Hospital - Dept of Hematology/Immunology	Sendai-shi
Korea, Republic of	Ajou University Hospital	Suwon
Mauritius	CAP Research Ltd	Quatre Bornes
Mexico	CAIMED Investigacion en salud S.A de C.V.	Ciudad de México
Mexico	Clinstile, S.A. de C.V.	Ciudad de México
Mexico	Consultorio Privado Dr. Miguel Cortes Hernandez	Cuernavaca
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	Centro de Investigacion Clínica GRAMEL S.C	Mexico
Mexico	Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas	Mexico
Mexico	Centro Regiomontano de Estudios Clínicos Roma S.C.	Monterrey
Mexico	CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni	Torreon
Moldova, Republic of	ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"	Chisinau
Philippines	Davao Doctors Hospital - Medicine	Davao City
Philippines	Iloilo Doctors Hospital	Iloilo City
Philippines	Ospital Ng Makati	Makati City
Poland	Nova Reuma Domyslawska i Rusilowicz, Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty	Bialystok
Poland	Prywatna Praktyka Lekarska prof Pawel Hrycaj	Koscian
Poland	Centrum Nowoczesnych Terapii Dobry Lekarz	Krakow
Poland	Centrum Medyczne Plejady	Kraków
Poland	Twoja Przychodnia PCM	Poznan
Serbia	Institute of Rheumatology	Belgrade
Serbia	Institute of Rheumatology	Belgrade
Serbia	University Clinical Center of Serbia - Clinic of Alergology and Imunology	Belgrade
South Africa	Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat	Cape Town
South Africa	Naidoo, A - Netcare Umhlanga Hospital	Umhlanga
Spain	Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia	Santander
Spain	Hospital Universitario Rio Hortega - Servicio de Medicina Interna	Valladolid
United States	AA MRC LLC Ahmed Arif Medical Research Center	Grand Blanc	Michigan
United States	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana
United States	Ramesh C Gupta, MD	Memphis	Tennessee
United States	Advance Medical Research Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Chile,  China,  Colombia,  Greece,  Japan,  Korea, Republic of,  Mauritius,  Mexico,  Moldova, Republic of,  Philippines,  Poland,  Serbia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected		Baseline up to Week 50
Secondary	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		Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Secondary	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		Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Secondary	Number of Participants With Based Composite Lupus Assessment (BICLA) Response		At Weeks 24 and 48
Secondary	Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response		At Weeks 24 and 48

External Links

•   Trial Awareness and Transparency website