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

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05540327

Collaborator

(none)

440

Enrollment

161

Locations

Arms

Anticipated Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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]).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: M5049 low dose Drug: M5049 medium dose Drug: M5049 high dose Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

440 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

May 26, 2025

Anticipated Study Completion Date :

Jun 14, 2025

Arms and Interventions

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 48 weeks. Other Names: Enpatoran Drug: Placebo Participants will receive M5049 matching placebo orally, BID for up to 48 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: M5049 medium dose Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks. Other Names: Enpatoran Drug: Placebo Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
Experimental: M5049 high dose 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: M5049 high dose Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks. Other Names: Enpatoran

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 48 weeks.

Other Names:

Enpatoran

Drug: Placebo

Participants will receive M5049 matching placebo orally, BID for up to 48 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: M5049 medium dose

Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.

Other Names:

Enpatoran

Drug: Placebo

Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.

Experimental: M5049 high dose

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: M5049 high dose

Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.

Other Names:

Enpatoran

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected [Baseline up to Week 50]
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]
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]
Number of Participants With Based Composite Lupus Assessment (BICLA) Response [At Weeks 24 and 48]
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response [At Weeks 24 and 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 76 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 range 18.5 to 35 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259
2	University of Arizona Arthritis Center	Tucson	Arizona	United States	85724
3	University of California San Diego Medical Center	La Jolla	California	United States	92093-1503
4	The Lundquist Institute at Harbor-UCLA Medical Center	Torrance	California	United States	90502
5	Bay Area Arthritis and Osteoporosis	Brandon	Florida	United States	33511
6	University of Florida College of Medicine Jacksonville	Jacksonville	Florida	United States	32207
7	Advance Medical Research Center	Miami	Florida	United States	33135
8	HMD Research, LLC	Orlando	Florida	United States	32819
9	D&H Tamarac Research Center, LLC	Tamarac	Florida	United States	33321
10	CenExel ForCare Clinical Research	Tampa	Florida	United States	33613
11	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana	United States	46250
12	Massachusetts General Hospital - Dermatology Clinic	Boston	Massachusetts	United States	02114
13	A MRC LLC Ahmed Arif Medical Research Center	Flint	Michigan	United States	48504
14	University of Minnesota	Minneapolis	Minnesota	United States	55455
15	Superior Clinical Research, LLC	Smithfield	North Carolina	United States	27577
16	Ohio State University	Columbus	Ohio	United States	43210
17	University of Toledo	Toledo	Ohio	United States	43614-2598
18	Rheumatology & Osteoporosis Institute of Oklahoma	Tulsa	Oklahoma	United States	74136
19	Ramesh C Gupta, MD	Memphis	Tennessee	United States	38119
20	Austin Regional Clinic, P.A.	Austin	Texas	United States	78731
21	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas	United States	76034
22	Jordan Valley Dermatology Center	South Jordan	Utah	United States	84095
23	Buenos Aires Skin	Ciudad Autonoma Buenos Aires		Argentina
24	Centro Dermatologico Schejtman	Ciudad Autonoma Buenos Aires		Argentina
25	CINME - Centro De Investigaciones Metabolicas	Ciudad Autonoma de Buenos Aires		Argentina
26	Centro de Investigaciones Medicas Mar del Plata - CIM	Mar del Plata		Argentina
27	Instituto de Reumatologia	Mendoza		Argentina
28	Instituto CAICI - Instituto Centralizado de Asistencia e Investigaci	Rosario		Argentina
29	Instituto Medico de la Fundacion Estudios Clinicos	Rosario		Argentina
30	Cordis S.A.	Salta		Argentina
31	Instituto Medico de alta Complejidad San Isidro S.A (IMAC)	San Fernando		Argentina
32	CER San Juan Centro Polivalente de Asistencia e Inv. Clinica	San Juan		Argentina
33	Investigaciones Clinicas Tucuman	San Miguel de Tucuman		Argentina
34	PSORIAHUE-Medicina Interdisciplinar	San Miguel		Argentina
35	Centro de Investigaciones Medicas Tucuman	Tucuman		Argentina
36	Box Hill Hospital - PARENT	Caulfield		Australia
37	Monash Medical Centre Clayton	Clayton		Australia
38	Fiona Stanley Hospital - Haematology	Murdoch		Australia
39	Royal Melbourne Hospital - PARENT	Parkville		Australia
40	Westmead Hospital - PARENT	Sydney		Australia
41	Colin Bayliss Research and Teaching Unit	Victoria Park		Australia
42	Veracity Clinical Research	Woolloongabba		Australia
43	Santa Casa de Misericórdia de Belo Horizonte	Belo Horizonte		Brazil
44	Oncovida - Centro de Onco-Hematologia de Mato Grosso	Cuiabá		Brazil
45	CETI - Centro de Estudos em Terapias Inovadoras Ltda.	Curitiba		Brazil
46	Edumed - Educação e Saúde SA	Curitiba		Brazil
47	HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará	Fortaleza		Brazil
48	CMiP - Centro Mineiro de Pesquisa	Juiz de Fora		Brazil
49	Hospital Bruno Born	Lajeado		Brazil
50	Hospital Moinhos de Vento	Porto Alegre		Brazil
51	Clínica SER da Bahia	Salvador		Brazil
52	Faculdade de Medicina do ABC	Santo André		Brazil
53	CEMEC - Centro Multidisciplinar de Estudos Clínicos	São Bernardo		Brazil
54	Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa	São José do Rio Preto		Brazil
55	CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos	São Paulo		Brazil
56	CPCLIN - Centro de Pesquisas Clínicas Ltda.	São Paulo		Brazil
57	DCC 'Sveti Georgi' EOOD - Cardiology Office	Haskovo		Bulgaria
58	Medical center Medconsult Pleven OOD	Pleven		Bulgaria
59	MC Artmed OOD	Plovdiv		Bulgaria
60	DCC 1 - Ruse, EOOD	Ruse		Bulgaria
61	Medical Center-1-Sevlievo EOOD	Sevlievo		Bulgaria
62	DCC "Alexandrovska", EOOD	Sofia		Bulgaria
63	DCC Focus 5 - MEOH OOD	Sofia		Bulgaria
64	Military Medical Academy - MHAT - Sofia - Department of Rheumatology	Sofia		Bulgaria
65	UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology	Sofia		Bulgaria
66	UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology	Sofia		Bulgaria
67	UMHAT Prof. Dr. Stoyan Kirkovich AD	Stara Zagora		Bulgaria
68	Clínica Alemana de Osorno	Osorno		Chile
69	BioMedica Research Group - Psicomedica Clinical and Research Group	Santiago		Chile
70	CeCim Biocinetic	Santiago		Chile
71	Centro Medico Prosalud	Santiago		Chile
72	Dermacross	Santiago		Chile
73	The First Affiliated Hospital of Baotou Medical College	Baotou		China
74	Peking Union Medical College Hospital - Beijing Union Medical College Hospital	Beijing		China
75	The First Hospital of Jilin University	Changchun		China
76	The 2nd Xiangya Hospital of Central South University	Changsha		China
77	West China Hospital, Sichuan University	Chengdu		China
78	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou		China
79	The Third Affiliated Hospital, Sun Yat-sen University	Guangzhou		China
80	Hainan General Hospital	Haikou		China
81	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot		China
82	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang		China
83	The Second Affiliated Hospital of Nanchang University	Nanchang		China
84	Hospital for Skin Diseases, Chinese Academy of Medical Sciences	Nanjing		China
85	Huashan Hospital, Fudan University	Shanghai		China
86	Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch	Shanghai		China
87	Ruijin Hospital of Shanghai Jiaotong University School of Medicine	Shanghai		China
88	The First Affiliated Hospital of Soochow University	SuZhou		China
89	Tianjin Medical University General Hospital	Tianjin		China
90	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an		China
91	Centro de Investigacion Medico Asistencial S.A.S	Barranquilla		Colombia
92	Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM	Bogotá		Colombia
93	Medicity S.A.S.	Bucaramanga		Colombia
94	Servimed S.A.S	Bucaramanga		Colombia
95	Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS	Medellin		Colombia
96	Healthy Medical Center	Zipaquirá		Colombia
97	General Hospital of Athens Laiko	Athens		Greece
98	General Hospital of Athens Laiko	Athens		Greece
99	University Hospital of Patra	Patra		Greece
100	424 General Military Hospital	Thessaloniki		Greece
101	General Hospital of Thessaloniki "Hippokration"	Thessaloniki		Greece
102	General Hospital Papageorgiou	Thessaloniki		Greece
103	Skin and Venereal Diseases' Hospital	Thessaloniki		Greece
104	Chaim Sheba Medical Center - pt	Ramat Gan		Israel
105	NHO Asahikawa Medical Center - Dept of Gastroenterology	Asahikawa-shi		Japan
106	St. Luke's International Hospital - Dept of Immunology/Allergy	Chuo-ku		Japan
107	Eiraku Clinic - Dept of Rheumatology	Kagoshima-shi		Japan
108	Saitama Medical Center - Dept of Rheumatology/Immunology	Kawagoe-shi		Japan
109	Kagawa University Hospital - Dept of Immunology/ Rheumatology	Kita-gun		Japan
110	Hokkaido University Hospital	Sapporo-shi		Japan
111	Tohoku University Hospital - Dept of Hematology/Immunology	Sendai-shi		Japan
112	Kyung Hee University Hospital at Gangdong	Seoul		Korea, Republic of
113	Ajou University Hospital	Suwon		Korea, Republic of
114	CAP Research Ltd	Quatre Bornes		Mauritius
115	CAIMED Investigacion en salud S.A de C.V.	Ciudad de México		Mexico
116	Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista	Cuernavaca		Mexico
117	Centro de Estudios de Investigacion Basica y Clinica SC	Guadalajara		Mexico
118	Diseño y Planeacion en Investigacion Medica S.C.	Guadalajara		Mexico
119	Hospital Clinica Angeles Chapalita	Guadalajara		Mexico
120	Centro de Investigacion Clínica GRAMEL S.C	Mexico		Mexico
121	Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B	Mexico		Mexico
122	Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran	Mexico		Mexico
123	Centro Regiomontano de Estudios Clínicos Roma S.C.	Monterrey		Mexico
124	Clinosar Mexico, S.A. de C.V.	México		Mexico
125	CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni	Torreon		Mexico
126	Medical Care & Research SA de CV	Yucatan		Mexico
127	ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"	Chisinau		Moldova, Republic of
128	GreenCity Medical Center	Angeles City, Pampanga		Philippines
129	Perpetual Succour Hospital	Cebu City		Philippines
130	Davao Doctors Hospital - Medicine	Davao City		Philippines
131	Iloilo Doctors Hospital	Iloilo City		Philippines
132	Mary Mediatrix Medical Center	Lipa City		Philippines
133	Chinese General Hospital & Medical Center	Manila		Philippines
134	Ospital Ng Makati	Quezon City		Philippines
135	Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health	QuezonCity		Philippines
136	Nova Reuma Spolka Partnerska	Bialystok		Poland
137	Prywatna Praktyka Lekarska prof Pawel Hrycaj	Koscian		Poland
138	Centrum Medyczne Plejady	Krakow		Poland
139	Centrum Nowoczesnych Terapii Dobry Lekarz	Krakow		Poland
140	Twoja Przychodnia Opolskie Centrum Medyczne	Opole		Poland
141	Twoja Przychodnia PCM	Poznan		Poland
142	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin		Poland
143	Clinical Best Solutions - Warszawa	Warszawa		Poland
144	Clinical Center of Serbia - Clinic of Alergology and Imunology	Belgrade		Serbia
145	Institute of Rheumatology	Belgrade		Serbia
146	Institute of Rheumatology	Belgrade		Serbia
147	Clinical Center Kragujevac	Kragujevac		Serbia
148	Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat	Cape Town		South Africa
149	University of Pretoria Clinical Research Unit - Parent	Pretoria		South Africa
150	Naidoo, A - Netcare Umhlanga Hospital	Umhlanga		South Africa
151	Accellacare - Alcobendas	Alcobendas		Spain
152	Hospital General de Castellon - Servicio de Reumatologia	Castellon		Spain
153	Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia	La Coruña		Spain
154	Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia	Madrid		Spain
155	Hospital Regional Universitario de Malaga - Reumatology Dept	Málaga		Spain
156	Hospital Quironsalud Sagrado Corazon - Reumatologia	Sevilla		Spain
157	Hospital Universitario Dr. Peset - Servicio de Reumatologia	Valencia		Spain
158	Hospital Universitario Rio Hortega - Servicio de Medicina Interna	Valladolid		Spain
159	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan
160	Cheng Hsin General Hospital	Taipei		Taiwan
161	Taipei Veterans General Hospital	Taipei		Taiwan