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

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M5049 low dose
M5049 medium dose
M5049 high dose
Placebo
M5049 very high dose
Sponsored by
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Toll-like Receptor 7, Toll-like Receptor 8, WILLOW, Adults, SLE, CLE, Lupus, Discoid lupus erythematosus, Subacute cutaneous lupus erythematosus, M5049, Enpatoran, LTE

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Advance Medical Research CenterRecruiting
  • Dawes Fretzin Dermatology Group, LLCRecruiting
  • AA MRC LLC Ahmed Arif Medical Research CenterRecruiting
  • Ramesh C Gupta, MDRecruiting
  • Centro de Investigaciones Medicas Mar del Plata - CIMRecruiting
  • Buenos Aires SkinRecruiting
  • CINME - Centro De Investigaciones MetabolicasRecruiting
  • Centro de Investigaciones Medicas Mar del Plata - CIMRecruiting
  • Instituto Medico de alta Complejidad San Isidro S.A (IMAC)Recruiting
  • CER San Juan Centro Polivalente de Asistencia e Inv. ClinicaRecruiting
  • Investigaciones Clinicas TucumanRecruiting
  • PSORIAHUE-Medicina InterdisciplinarRecruiting
  • Centro de Investigaciones Medicas TucumanRecruiting
  • Monash Medical Centre ClaytonRecruiting
  • MC Artmed OODRecruiting
  • DCC 1 Sevlievo EOODRecruiting
  • DCC Focus 5 - MEOH OODRecruiting
  • Military Medical Academy - MHAT - SofiaRecruiting
  • UMHAT "Sv. Ivan Rilski", EAD - Clinic of RheumatologyRecruiting
  • UMHAT "Sv. Ivan Rilski", EAD - Clinica of RheumatologyRecruiting
  • BioMedica Research Group - Psicomedica Clinical and Research GroupRecruiting
  • Centro Medico ProsaludRecruiting
  • CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania LtdaRecruiting
  • The First Affiliated Hospital of Baotou Medical CollegeRecruiting
  • Peking Union Medical College Hospital - Beijing Union Medical College HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Centro de Investigacion Medico Asistencial S.A.SRecruiting
  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEMRecruiting
  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SASRecruiting
  • Healthy Medical CenterRecruiting
  • General Hospital PapageorgiouRecruiting
  • St. Luke's International Hospital - Dept of Immunology/AllergyRecruiting
  • Eiraku Clinic - Dept of RheumatologyRecruiting
  • Kagawa University Hospital - Dept of Immunology/ RheumatologyRecruiting
  • Tohoku University Hospital - Dept of Hematology/ImmunologyRecruiting
  • Ajou University HospitalRecruiting
  • CAP Research LtdRecruiting
  • CAIMED Investigacion en salud S.A de C.V.Recruiting
  • Clinstile, S.A. de C.V.Recruiting
  • Consultorio Privado Dr. Miguel Cortes HernandezRecruiting
  • Diseno y Planeacion en Investigacion Medica S.C.Recruiting
  • Diseño y Planeacion en Investigacion Medica S.C.Recruiting
  • Centro Medico del AngelRecruiting
  • Centro de Investigacion Clínica GRAMEL S.CRecruiting
  • Clinica para el Diagnostico y Tratamiento de las Enfermedades ReumaticasRecruiting
  • Centro Regiomontano de Estudios Clínicos Roma S.C.Recruiting
  • CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto BazzoniRecruiting
  • ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"Recruiting
  • Davao Doctors Hospital - MedicineRecruiting
  • Iloilo Doctors HospitalRecruiting
  • Ospital Ng MakatiRecruiting
  • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i FizjoterapeutyRecruiting
  • Prywatna Praktyka Lekarska prof Pawel HrycajRecruiting
  • Centrum Nowoczesnych Terapii Dobry LekarzRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Twoja Przychodnia PCMRecruiting
  • Institute of RheumatologyRecruiting
  • Institute of RheumatologyRecruiting
  • University Clinical Center of Serbia - Clinic of Alergology and ImunologyRecruiting
  • Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB BhoratRecruiting
  • Naidoo, A - Netcare Umhlanga HospitalRecruiting
  • Hospital Universitario Marques de Valdecilla - Servicio de ReumatologiaRecruiting
  • Hospital Universitario Rio Hortega - Servicio de Medicina InternaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

M5049 low dose + Placebo

M5049 medium dose+ Placebo

M5049 high dose + Placebo

M5049 very high dose + Placebo

Arm Description

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.

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.

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 .

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.

Outcomes

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)

Secondary Outcome Measures

Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
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
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
Number of Participants With Based Composite Lupus Assessment (BICLA) Response
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response

Full Information

First Posted
September 12, 2022
Last Updated
October 23, 2023
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05540327
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
532 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M5049 low dose + Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
M5049 medium dose+ Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
M5049 high dose + Placebo
Arm Type
Experimental
Arm Description
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 .
Arm Title
M5049 very high dose + Placebo
Arm Type
Experimental
Arm Description
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.
Intervention Type
Drug
Intervention Name(s)
M5049 low dose
Other Intervention Name(s)
Enpatoran
Intervention Description
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
M5049 medium dose
Other Intervention Name(s)
Enpatoran
Intervention Description
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
M5049 high dose
Other Intervention Name(s)
Enpatoran
Intervention Description
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
M5049 very high dose
Other Intervention Name(s)
Enpatoran
Intervention Description
Participants will receive film-coated tablets of M5049 at a very high dose orally, BID for up to 48 weeks.
Primary Outcome Measure Information:
Title
Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
Time Frame
Baseline up to Week 50
Secondary Outcome Measure Information:
Title
Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected
Time Frame
Baseline up to Week 50
Title
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
Time Frame
Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Title
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
Time Frame
Baseline (WILLOW study), Weeks 0, 2, 4, 12, 24, 36 and 48
Title
Number of Participants With Based Composite Lupus Assessment (BICLA) Response
Time Frame
At Weeks 24 and 48
Title
Number of Participants With Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response
Time Frame
At Weeks 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Advance Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
advancemedicalresearchcenter@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana M Acosta
Facility Name
Dawes Fretzin Dermatology Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dfcrgfretzin@ecommunity.com
First Name & Middle Initial & Last Name & Degree
Scott Fretzin
Facility Name
AA MRC LLC Ahmed Arif Medical Research Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
akarrar@aamrc.net
First Name & Middle Initial & Last Name & Degree
Ali A Karrar
Facility Name
Ramesh C Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
rcgupta42001@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ramesh Gupta
Facility Name
Centro de Investigaciones Medicas Mar del Plata - CIM
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
alicia.testa@cimmdp.com
First Name & Middle Initial & Last Name & Degree
Gladys Alicia Testa
Facility Name
Buenos Aires Skin
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
matiasturienzo@gmail.com
First Name & Middle Initial & Last Name & Degree
Matias Turienzo
Facility Name
CINME - Centro De Investigaciones Metabolicas
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
ricardo.galimberti@gmail.com
First Name & Middle Initial & Last Name & Degree
Ricardo L Galimberti
Facility Name
Centro de Investigaciones Medicas Mar del Plata - CIM
City
Mar del Plata
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
alicia.testa@cimmdp.com
First Name & Middle Initial & Last Name & Degree
Gladys Alicia Testa
Facility Name
Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
City
San Fernando
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
dralazaro@me.com
First Name & Middle Initial & Last Name & Degree
Maria Alicia Lazaro
Facility Name
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
City
San Juan
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
cristianmoreno@cersanjuan.com.ar
First Name & Middle Initial & Last Name & Degree
Jose Luis Cristian Moreno
Facility Name
Investigaciones Clinicas Tucuman
City
San Miguel de Tucuman
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
vbellomio@gmail.com
First Name & Middle Initial & Last Name & Degree
Veronica Ines Bellomio
Facility Name
PSORIAHUE-Medicina Interdisciplinar
City
San Miguel
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
gabriel.magarinos@gmail.com
First Name & Middle Initial & Last Name & Degree
Gabriel A Magarinos
Facility Name
Centro de Investigaciones Medicas Tucuman
City
Tucuman
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
walspindler@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
Walter J Spindler
Facility Name
Monash Medical Centre Clayton
City
Clayton
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
alberta.hoi@monash.edu
First Name & Middle Initial & Last Name & Degree
Alberta Hoi
Facility Name
MC Artmed OOD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
genevapopova@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mariela Geneva-Popova
Facility Name
DCC 1 Sevlievo EOOD
City
Sevlievo
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
dr.dimitar.nikolov@gmail.com
First Name & Middle Initial & Last Name & Degree
Dimitar Nikolov
Facility Name
DCC Focus 5 - MEOH OOD
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
grisha_mateev@yahoo.com
First Name & Middle Initial & Last Name & Degree
Grisha Mateev
Facility Name
Military Medical Academy - MHAT - Sofia
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
oparanov@abv.bg
First Name & Middle Initial & Last Name & Degree
Boycho Oparanov
Facility Name
UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
rmstoilov@abv.bg
First Name & Middle Initial & Last Name & Degree
Rumen Stoilov
Facility Name
UMHAT "Sv. Ivan Rilski", EAD - Clinica of Rheumatology
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
proff_rashkov@yahoo.com
First Name & Middle Initial & Last Name & Degree
Rasho Rashkov
Facility Name
BioMedica Research Group - Psicomedica Clinical and Research Group
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Email
emorenogster@gmail.com
First Name & Middle Initial & Last Name & Degree
Elizabeth Jean Moreno Goio
Facility Name
Centro Medico Prosalud
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Email
agoecke.prosalud@gmail.com
First Name & Middle Initial & Last Name & Degree
Irmgadt Annelise Goecke Sariego
Facility Name
CIEC- Centro Internacional de Estudios Clinicos - Valenzuela Y Compania Ltda
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Email
dr.fvalenzuela@gmail.com
First Name & Middle Initial & Last Name & Degree
Fernando Valenzuela
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
wyf18686198868@163.com
First Name & Middle Initial & Last Name & Degree
Yongfu Wang
Facility Name
Peking Union Medical College Hospital - Beijing Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
xiaofeng.zeng@cstar.org.cn
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
jzyd0197@163.com
First Name & Middle Initial & Last Name & Degree
Zhenyu Jiang
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
sxf64817332@163.com
First Name & Middle Initial & Last Name & Degree
Xiaofei Shi
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
13970085678@163.com
First Name & Middle Initial & Last Name & Degree
Xinwang Duan
Facility Name
West China Hospital, Sichuan University
City
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
yi2006liu@163.com
First Name & Middle Initial & Last Name & Degree
Yi Liu
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
tjweiwei2003@163.com
First Name & Middle Initial & Last Name & Degree
Wei Wei
Facility Name
Centro de Investigacion Medico Asistencial S.A.S
City
Barranquilla
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
Email
juanjaller@cimedical.co
First Name & Middle Initial & Last Name & Degree
Juan Jose Jaller Raad
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
City
Bogotá
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
Email
patriciavelez@cireem.com.co
First Name & Middle Initial & Last Name & Degree
Patricia Julieta Velez Sanchez
Facility Name
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
City
Medellin
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
Email
mabello@circaribe.com
First Name & Middle Initial & Last Name & Degree
Mauricio Ricardo Abello Banfi
Facility Name
Healthy Medical Center
City
Zipaquirá
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
Email
danny.gomez@healthymc.com
First Name & Middle Initial & Last Name & Degree
Danny Alexis Gomez Mora
Facility Name
General Hospital Papageorgiou
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
bethlaz@auth.gr
First Name & Middle Initial & Last Name & Degree
Elisavet Lazaridou
Facility Name
St. Luke's International Hospital - Dept of Immunology/Allergy
City
Chuo-ku
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
nakaith@luke.ac.jp
First Name & Middle Initial & Last Name & Degree
Takehiro Nakai
Facility Name
Eiraku Clinic - Dept of Rheumatology
City
Kagoshima-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
chiken-eiraku@eiraku-clinic.com
First Name & Middle Initial & Last Name & Degree
Nobutaka Eiraku
Facility Name
Kagawa University Hospital - Dept of Immunology/ Rheumatology
City
Kita-gun
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
dobashi.hiroaki@kagawa-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Hiroaki Dobashi
Facility Name
Tohoku University Hospital - Dept of Hematology/Immunology
City
Sendai-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
tishii@med.tohoku.ac.jp
First Name & Middle Initial & Last Name & Degree
Tomonori Ishii
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
chsuh@ajou.ac.kr
First Name & Middle Initial & Last Name & Degree
Chang-Hee Suh
Facility Name
CAP Research Ltd
City
Quatre Bornes
Country
Mauritius
Individual Site Status
Recruiting
Facility Contact:
Email
poojdev.jhugroo@cap-research.com
First Name & Middle Initial & Last Name & Degree
Poojdev Jhugroo
Facility Name
CAIMED Investigacion en salud S.A de C.V.
City
Ciudad de México
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
draferrusquia@gmail.com
First Name & Middle Initial & Last Name & Degree
Diana Laura Ferrusquía Toriz
Facility Name
Clinstile, S.A. de C.V.
City
Ciudad de México
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
f.enriquez@clinstile.com
First Name & Middle Initial & Last Name & Degree
Favio Edmundo Enriquez Sosa
Facility Name
Consultorio Privado Dr. Miguel Cortes Hernandez
City
Cuernavaca
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
neoral2000@yahoo.com
First Name & Middle Initial & Last Name & Degree
Miguel Cortes Hernandez
Facility Name
Diseno y Planeacion en Investigacion Medica S.C.
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
joraguil@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jorge Enrique Aguilar Arreola
Facility Name
Diseño y Planeacion en Investigacion Medica S.C.
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
joraguil@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jorge Enrique Aguilar Arreola
Facility Name
Centro Medico del Angel
City
Mexicali
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
bezazu@prodigy.net.mx
First Name & Middle Initial & Last Name & Degree
Beatriz Elena Zazueta Montiel
Facility Name
Centro de Investigacion Clínica GRAMEL S.C
City
Mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
luis.jara@gramel.com.mx
First Name & Middle Initial & Last Name & Degree
Luis Javier Jara Quezada
Facility Name
Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas
City
Mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
gabrielmedranor@msn.com
First Name & Middle Initial & Last Name & Degree
Gabriel Medrano Ramirez
Facility Name
Centro Regiomontano de Estudios Clínicos Roma S.C.
City
Monterrey
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
iriscolunga@hotmail.com
First Name & Middle Initial & Last Name & Degree
Iris J Colunga Pedraza
Facility Name
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
City
Torreon
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
sicsik69@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sandra Araceli Sicsik Ayala
Facility Name
ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
svetlana.agachi@arensia-em.com
First Name & Middle Initial & Last Name & Degree
Svetlana Agachi
Facility Name
Davao Doctors Hospital - Medicine
City
Davao City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
lhao88@yahoo.com
First Name & Middle Initial & Last Name & Degree
Llewellyn Hao
Facility Name
Iloilo Doctors Hospital
City
Iloilo City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
carroyo1104@gmail.com
First Name & Middle Initial & Last Name & Degree
Caroline G Arroyo
Facility Name
Ospital Ng Makati
City
Makati City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
esvista@stlukes.com.ph
First Name & Middle Initial & Last Name & Degree
Evan Glenn Vista
Facility Name
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
City
Bialystok
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
izadomyslawska@o2.pl
First Name & Middle Initial & Last Name & Degree
Izabela Domyslawska
Facility Name
Prywatna Praktyka Lekarska prof Pawel Hrycaj
City
Koscian
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
pawel.hrycaj@gmail.com
First Name & Middle Initial & Last Name & Degree
Pawel Hrycaj
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz
City
Krakow
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
wojciech.sydor@dobrylekarz.com.pl
First Name & Middle Initial & Last Name & Degree
Wojciech Sydor
Facility Name
Centrum Medyczne Plejady
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
magdalena.lowenhoff@gmail.com
First Name & Middle Initial & Last Name & Degree
Magdalena Celinska Lowenhoff
Facility Name
Twoja Przychodnia PCM
City
Poznan
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
wytyk@twojaprzychodnia.com
First Name & Middle Initial & Last Name & Degree
Agata Wytyk-Nowak
Facility Name
Institute of Rheumatology
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Email
drpedja74@hotmail.com
First Name & Middle Initial & Last Name & Degree
Predrag Ostojic
Facility Name
Institute of Rheumatology
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Email
sefikbukilicam@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mirjana Sefik Bukilica
Facility Name
University Clinical Center of Serbia - Clinic of Alergology and Imunology
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Email
snezana.arandjelovic2019@gmail.com
First Name & Middle Initial & Last Name & Degree
Snezana Arandjelovic
Facility Name
Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB Bhorat
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
Email
spargoc@rheumatologists.co.za
First Name & Middle Initial & Last Name & Degree
Catherine E Spargo
Facility Name
Naidoo, A - Netcare Umhlanga Hospital
City
Umhlanga
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
Email
asokan@webmail.co.za
First Name & Middle Initial & Last Name & Degree
Asokan Naidoo
Facility Name
Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
ensayosreumavaldecilla@gmail.com
First Name & Middle Initial & Last Name & Degree
Ricardo Blanco Alonso
Facility Name
Hospital Universitario Rio Hortega - Servicio de Medicina Interna
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
jbarbadoa@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Maria Julia Barbado Ajo

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing 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
IPD Sharing 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.
IPD Sharing URL
https://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200569_0048
Description
Trial Awareness and Transparency website

Learn more about this trial

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

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