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The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Enpatoran low dose
Enpatoran medium dose
Enpatoran high dose
Placebo
Sponsored by
EMD Serono Research & Development Institute, Inc.
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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
  • Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
  • Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Autoimmune or rheumatic disease other than SLE or CLE
  • Dermatological diseases other than cutaneous manifestations of SLE or CLE
  • Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
  • Ongoing or active clinically significant viral, bacterial, or fungal infection
  • History of uncontrolled seizures or other neurological disorder
  • History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
  • History of malignancy
  • Other protocol defined exclusion criteria could apply

Sites / Locations

  • The Lundquist Institute at Harbor-UCLA Medical CenterRecruiting
  • Bay Area Arthritis and OsteoporosisRecruiting
  • Charisma Medical and Research CenterRecruiting
  • Advance Medical Research CenterRecruiting
  • New Horizon Research Center, IncRecruiting
  • HMD Research, LLCRecruiting
  • D&H Tamarac Research Center, LLCRecruiting
  • Model Research Center, LLC
  • RNA America Health SciencesRecruiting
  • Dawes Fretzin Dermatology Group, LLCRecruiting
  • AA MRC LLC Ahmed Arif Medical Research CenterRecruiting
  • University of MinnesotaRecruiting
  • Across the Life SpanRecruiting
  • Ohio State University - CTMO ParentRecruiting
  • University of Toledo - PARENTRecruiting
  • Rheumatology & Osteoporosis Institute of OklahomaRecruiting
  • Ramesh C Gupta, MD - Memphis, TNRecruiting
  • Austin Regional Clinic, P.A.
  • Precision Comprehensive Clinical Research SolutionsRecruiting
  • Jordan Valley Dermatology CenterRecruiting
  • Buenos Aires SkinRecruiting
  • Centro Dermatologico SchejtmanRecruiting
  • Hospital Militar Central Dr. Cosme ArgerichRecruiting
  • CINME - Centro De Investigaciones MetabolicasRecruiting
  • Centro de Investigaciones Medicas Mar del Plata - CIMRecruiting
  • Instituto de ReumatologiaRecruiting
  • Instituto Medico de la Fundacion Estudios ClinicosRecruiting
  • Cordis S.A.Recruiting
  • Investigaciones Clínicas Salta (ICSAL)Recruiting
  • 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
  • Box Hill Hospital - PARENTRecruiting
  • Monash Medical Centre ClaytonRecruiting
  • Fiona Stanley Hospital - HaematologyRecruiting
  • Royal Melbourne Hospital - PARENTRecruiting
  • Westmead Hospital - SUPERSEDEDRecruiting
  • Veracity Clinical ResearchRecruiting
  • Santa Casa de Misericórdia de Belo HorizonteRecruiting
  • Oncovida - Centro de Onco-Hematologia de Mato GrossoRecruiting
  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.Recruiting
  • Edumed - Educação e Saúde SARecruiting
  • CMiP - Centro Mineiro de PesquisaRecruiting
  • Hospital Bruno BornRecruiting
  • Hospital Moinhos de VentoRecruiting
  • Clínica SER da BahiaRecruiting
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de PesquisaRecruiting
  • CPCLIN - Centro de Pesquisas Clínicas Ltda.Recruiting
  • CEPIC - Centro Paulista de Investigação Clínica e Serviços MédicosRecruiting
  • DCC 'Sveti Georgi' EOOD - Cardiology OfficeRecruiting
  • Medical center Medconsult Pleven OOD
  • MC Artmed OODRecruiting
  • DCC 1 - Ruse, EOODRecruiting
  • Medical Center-1-Sevlievo EOODRecruiting
  • DCC "Alexandrovska", EOODRecruiting
  • DCC Focus 5 - MEOH OODRecruiting
  • Military Medical Academy - MHAT - Sofia - Department of RheumatologyRecruiting
  • UMHAT "Sv. Ivan Rilski", EAD - Clinic of RheumatologyRecruiting
  • UMHAT Prof. Dr. Stoyan Kirkovich ADRecruiting
  • Clínica Alemana de OsornoRecruiting
  • BioMedica Research Group - Psicomedica Clinical and Research GroupRecruiting
  • CeCim BiocineticRecruiting
  • Centro Medico ProsaludRecruiting
  • CIEC - Centro Internacional de Estudios Clínicos - Valenzuela Y Compania LtdaRecruiting
  • DermacrossRecruiting
  • 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 2nd Xiangya Hospital of Central South UniversityRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Guangdong Provincial People's Hospital - OncologyRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • Hainan General HospitalRecruiting
  • The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • Hospital for Skin Diseases, Chinese Academy of Medical SciencesRecruiting
  • The Affiliated Drum Tower Hospital of Nanjing UniversityRecruiting
  • Huashan Hospital, Fudan UniversityRecruiting
  • Renji Hospital Shanghai Jiaotong University School of Medicine - West BranchRecruiting
  • Ruijin Hospital of Shanghai Jiaotong University School of MedicineRecruiting
  • Shanghai Skin Disease HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Centro de Investigacion Medico Asistencial S.A.SRecruiting
  • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.Recruiting
  • Servimed S.A.S.Recruiting
  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SASRecruiting
  • Healthy Medical CenterRecruiting
  • "Andreas Syggros" Hospital - Department of DermatologyRecruiting
  • General Hospital of Athens LaikoRecruiting
  • University Hospital of PatraRecruiting
  • General Hospital of Thessaloniki "Hippokration"Recruiting
  • General Hospital PapageorgiouRecruiting
  • Skin and Venereal Diseases' HospitalRecruiting
  • Chaim Sheba Medical Center - ptRecruiting
  • NHO Asahikawa Medical Center - Dept of GastroenterologyRecruiting
  • NHO Chibahigashi National Hospital - Dept of Allergy/RheumatologyRecruiting
  • St. Luke's International Hospital - Dept of Immunology/AllergyRecruiting
  • Hiroshima University Hospital - Dept of Rheumatology/ImmunologyRecruiting
  • Eiraku Clinic - Dept of RheumatologyRecruiting
  • Kanazawa University Hospital - Dept of Rheumatology/ImmunologyRecruiting
  • Saitama Medical Center - Dept of Rheumatology/ImmunologyRecruiting
  • Kagawa University Hospital - Dept of Immunology/ RheumatologyRecruiting
  • Toho University Ohashi Medical Center - Dept of Immunology/RheumatologyRecruiting
  • Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/ImmunologRecruiting
  • Tohoku University Hospital - Dept of Hematology/ImmunologyRecruiting
  • Ehime University Hospital - Dept of Immunology/RheumatologyRecruiting
  • Pusan National University HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Kyung Hee University Hospital at Gangdong:
  • Seoul National University HospitalRecruiting
  • Ajou University HospitalRecruiting
  • CAP Research LtdRecruiting
  • CAIMED Investigacion en salud S.A de C.V.Recruiting
  • Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas VistaRecruiting
  • Centro de Estudios de Investigacion Basica y Clinica SCRecruiting
  • Consultorio Médico del Dr. Federico Galván VillegasRecruiting
  • Diseño y Planeacion en Investigacion Medica S.C.Recruiting
  • Centro Medico del AngelRecruiting
  • Centro de Investigacion Clínica GRAMEL S.CRecruiting
  • Citer, Centro de Investigación Y Tratamiento de Las Enfermedades Reumaticas Sa de CvRecruiting
  • Clinstile, S.A. de C.V.Recruiting
  • Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445BRecruiting
  • Grupo Medico Camino S.C.Recruiting
  • Centro Regiomontano de Estudios Clínicos Roma S.C.Recruiting
  • AMAF Clinical Research S.CRecruiting
  • CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto BazzoniRecruiting
  • Medical Care & Research SA de CVRecruiting
  • ICS ARENSIA Exploratory Medicine SRL - Republican Clinical Hospital "Timofei Mosneaga"Recruiting
  • Green City Medical CenterRecruiting
  • Perpetual Succour HospitalRecruiting
  • Davao Doctors Hospital - MedicineRecruiting
  • Iloilo Doctors HospitalRecruiting
  • Mary Mediatrix Medical CenterRecruiting
  • Chinese General Hospital & Medical CenterRecruiting
  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child HealthRecruiting
  • Ospital Ng MakatiRecruiting
  • Nova Reuma Spolka PartnerskaRecruiting
  • Prywatna Praktyka Lekarska prof Pawel HrycajRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Centrum Nowoczesnych Terapii Dobry LekarzRecruiting
  • Twoja Przychodnia Opolskie Centrum MedyczneRecruiting
  • Twoja Przychodnia PCMRecruiting
  • Twoja Przychodnia-Szczecinskie Centrum MedyczneRecruiting
  • Clinical Best Solutions - WarszawaRecruiting
  • Centrul Medical Monza SRL - Arensia Exploratory MedicineRecruiting
  • S.C Delta Health Care S.R.L - Ponderas Academic HospitalRecruiting
  • Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si ReumatologieRecruiting
  • Spitalul Clinic "Sf. Maria" - parentRecruiting
  • Spitalul Clinic Colentina - parentRecruiting
  • Sc Medaudio-Optica SRLRecruiting
  • Institute of Rheumatology- 1Recruiting
  • Institute of Rheumatology-1Recruiting
  • Institute of RheumatologyRecruiting
  • University Clinical Center of Serbia - Clinic of Alergology and ImunologyRecruiting
  • University Clinical Center KragujevacRecruiting
  • Arthritis Clinical Research Trial Unit - Dr CE Spargo and Dr RB BhoratRecruiting
  • University of Pretoria Clinical Research Unit - ParentRecruiting
  • Naidoo, A - Netcare Umhlanga Hospital
  • Hospital General de Castellon - Servicio de ReumatologiaRecruiting
  • Complejo Hospitalario Universitario A Coruña - Servicio de ReumatologiaRecruiting
  • Hospital Universitario 12 de Octubre - Servicio de ReumatologiaRecruiting
  • Hospital Regional Universitario de Malaga - Reumatology DeptRecruiting
  • Hospital Universitario Marques de Valdecilla - Servicio de ReumatologiaRecruiting
  • Hospital Quironsalud Sagrado Corazon - ReumatologiaRecruiting
  • Hospital Universitario Dr. Peset - Servicio de ReumatologiaRecruiting
  • Hospital Universitario Rio Hortega - Servicio de Medicina InternaRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Cheng Hsin General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Cohort A: Placebo

Cohort A: Enpatoran low dose

Cohort A: Enpatoran medium dose

Cohort A: Enpatoran high dose

Cohort B (Part 1 + Part 2): Placebo

Cohort B (Part 1 + Part 2): Enpatoran high dose

Cohort B (Part 2): Enpatoran low dose

Cohort B (Part 2): Enpatoran medium dose

Arm Description

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.

Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.

Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .

Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.

Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive low dose of M5049.

Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive medium dose of Enpatoran.

Outcomes

Primary Outcome Measures

Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24

Secondary Outcome Measures

Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected
Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24
Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24
Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction
CS reduction is defined as the reduction of daily prednisone-equivalent dose from >= 10 mg at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24.
Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction
CS reduction is defined as the reduction of daily prednisone-equivalent dose from >= 10 mg at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24.
Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24
Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
Cohort B: Lupus Low Disease Activity State (LLDAS) Attainment at Week 24
Cohort B: Remission Attainment at Week 24
Cohort B: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 24
Cohort B: Change from Baseline in Physician's Global Assessment at Week 24
Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare
Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare
Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24
Cohort A and B: Change from Baseline in the Skindex 29+3 Functioning and Emotion Domain Scores at Week 24
Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24
Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24

Full Information

First Posted
December 8, 2021
Last Updated
October 10, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05162586
Brief Title
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
July 8, 2024 (Anticipated)
Study Completion Date
August 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
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
Yes

5. Study Description

Brief Summary
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.
Arm Title
Cohort A: Enpatoran low dose
Arm Type
Experimental
Arm Description
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.
Arm Title
Cohort A: Enpatoran medium dose
Arm Type
Experimental
Arm Description
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.
Arm Title
Cohort A: Enpatoran high dose
Arm Type
Experimental
Arm Description
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.
Arm Title
Cohort B (Part 1 + Part 2): Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .
Arm Title
Cohort B (Part 1 + Part 2): Enpatoran high dose
Arm Type
Experimental
Arm Description
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.
Arm Title
Cohort B (Part 2): Enpatoran low dose
Arm Type
Experimental
Arm Description
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive low dose of M5049.
Arm Title
Cohort B (Part 2): Enpatoran medium dose
Arm Type
Experimental
Arm Description
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive medium dose of Enpatoran.
Intervention Type
Drug
Intervention Name(s)
Enpatoran low dose
Other Intervention Name(s)
M5049
Intervention Description
Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Enpatoran medium dose
Other Intervention Name(s)
M5049
Intervention Description
Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Enpatoran high dose
Other Intervention Name(s)
M5049
Intervention Description
Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo matched to Enpatoran up to 24 weeks.
Primary Outcome Measure Information:
Title
Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
Time Frame
Baseline, Week 16
Title
Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected
Time Frame
Baseline (Day 1) up to End of Safety Follow-up Period (Week 33)
Title
Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24
Time Frame
Baseline, Week 16 and 24
Title
Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24
Time Frame
Baseline, Week 16 and 24
Title
Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction
Description
CS reduction is defined as the reduction of daily prednisone-equivalent dose from >= 10 mg at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24.
Time Frame
Day 1 up to Week 24
Title
Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction
Description
CS reduction is defined as the reduction of daily prednisone-equivalent dose from >= 10 mg at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24.
Time Frame
Day 1 up to Week 24
Title
Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24
Time Frame
At Week 16 and 24
Title
Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
Time Frame
At Week 24
Title
Cohort B: Lupus Low Disease Activity State (LLDAS) Attainment at Week 24
Time Frame
At Week 24
Title
Cohort B: Remission Attainment at Week 24
Time Frame
At Week 24
Title
Cohort B: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 24
Time Frame
Baseline, Week 24
Title
Cohort B: Change from Baseline in Physician's Global Assessment at Week 24
Time Frame
Baseline, Week 24
Title
Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare
Time Frame
Day 1 through Week 24
Title
Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare
Time Frame
Day 1 through Week 24
Title
Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24
Time Frame
Baseline, Week 24
Title
Cohort A and B: Change from Baseline in the Skindex 29+3 Functioning and Emotion Domain Scores at Week 24
Time Frame
Baseline, Week 24
Title
Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24
Time Frame
Baseline, Week 24
Title
Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8 Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8 Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids Other protocol defined inclusion criteria could apply Exclusion Criteria: Autoimmune or rheumatic disease other than SLE or CLE Dermatological diseases other than cutaneous manifestations of SLE or CLE Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder Ongoing or active clinically significant viral, bacterial, or fungal infection History of uncontrolled seizures or other neurological disorder History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus History of malignancy Other protocol defined exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
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
EMD Serono Research & Development Institute, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Lundquist Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
gkarpouzas@lundquist.org
First Name & Middle Initial & Last Name & Degree
George Karpouzas
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
baao2010@msn.com
First Name & Middle Initial & Last Name & Degree
Vipul Joshi
Facility Name
Charisma Medical and Research Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
mrensolipi@charismaresearch.net
First Name & Middle Initial & Last Name & Degree
Marimer Rensoli Velazquez
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
acostaadvance@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana M Acosta
Facility Name
New Horizon Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
lnunez@nhorizonresearch.com
First Name & Middle Initial & Last Name & Degree
Lazaro D Nunez
Facility Name
HMD Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
mheuer@heuermd.com
First Name & Middle Initial & Last Name & Degree
Marvin A Heuer
Facility Name
D&H Tamarac Research Center, LLC
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dravalos@dhtrc.com
First Name & Middle Initial & Last Name & Degree
Anneyd M Avalos Pena
Facility Name
Model Research Center, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Withdrawn
Facility Name
RNA America Health Sciences
City
Sugar Hill
State/Province
Georgia
ZIP/Postal Code
30518
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
rfaiyaz@rnaamerica.com
First Name & Middle Initial & Last Name & Degree
Roohi Faiyaz
Facility Name
Dawes Fretzin Dermatology Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dfcrgfretzin@ecommunity.com
First Name & Middle Initial & Last Name & Degree
Scott A 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
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
pearsond@umn.edu
First Name & Middle Initial & Last Name & Degree
David R Pearson
Facility Name
Across the Life Span
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
27577
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dr.curtis@superiorclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Clifford Curtis
Facility Name
Ohio State University - CTMO Parent
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
benjamin.kaffenberger@osumc.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Kaffenberger
Facility Name
University of Toledo - PARENT
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
nezam.altorok@utoledo.edu
First Name & Middle Initial & Last Name & Degree
Nezam I Altorok
Facility Name
Rheumatology & Osteoporosis Institute of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dgfoley@premier-rheum.com
First Name & Middle Initial & Last Name & Degree
Debbie Gladd
Facility Name
Ramesh C Gupta, MD - Memphis, TN
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 C Gupta
Facility Name
Austin Regional Clinic, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Withdrawn
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dhimanbasu@pccrsolutions.com
First Name & Middle Initial & Last Name & Degree
Dhiman Basu
Facility Name
Jordan Valley Dermatology Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
dforsha@jvderm.com
First Name & Middle Initial & Last Name & Degree
Douglass Forsha
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
Centro Dermatologico Schejtman
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
ale_mmzgonc@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
Alejandro Martinez Muñoz
Facility Name
Hospital Militar Central Dr. Cosme Argerich
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
guscasado@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gustavo Christian Casado
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 de Reumatologia
City
Mendoza
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
alborgia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Alfredo Borgia
Facility Name
Instituto Medico de la Fundacion Estudios Clinicos
City
Rosario
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
anaclaracaminer@consultoriosintegrados.org
First Name & Middle Initial & Last Name & Degree
Ana Clara Caminer
Facility Name
Cordis S.A.
City
Salta
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
dra.zurlo@gmail.com
First Name & Middle Initial & Last Name & Degree
Leticia Ibanez Zurlo
Facility Name
Investigaciones Clínicas Salta (ICSAL)
City
Salta
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
vbellomio@gmail.com
First Name & Middle Initial & Last Name & Degree
Veronica Ines Bellomio
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
Box Hill Hospital - PARENT
City
Caulfield
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
christopher.fong@monash.edu
First Name & Middle Initial & Last Name & Degree
Christopher Fong
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
Fiona Stanley Hospital - Haematology
City
Murdoch
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
helen.keen@uwa.edu.au
First Name & Middle Initial & Last Name & Degree
Helen Keen
Facility Name
Royal Melbourne Hospital - PARENT
City
Parkville
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
johannes.kern@mh.org.au
First Name & Middle Initial & Last Name & Degree
Johannes S Kern
Facility Name
Westmead Hospital - SUPERSEDED
City
Westmead
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
pablo.fernandezpenas@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Pablo Fernandez-Penas
Facility Name
Veracity Clinical Research
City
Woolloongabba
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
spelchat@veracity.net.au
First Name & Middle Initial & Last Name & Degree
Lynda Spelman
Facility Name
Santa Casa de Misericórdia de Belo Horizonte
City
Belo Horizonte
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
claudiasneiva@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Claudia Lopes Santoro Neiva
Facility Name
Oncovida - Centro de Onco-Hematologia de Mato Grosso
City
Cuiabá
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
lsgbarbosa@gmail.com
First Name & Middle Initial & Last Name & Degree
Luiz Sergio Guedes Barbosa
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
City
Curitiba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
rbr@uol.com.br
First Name & Middle Initial & Last Name & Degree
Sebastiao Cezar Radominski
Facility Name
Edumed - Educação e Saúde SA
City
Curitiba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
valderilio@hotmail.com
First Name & Middle Initial & Last Name & Degree
Valderílio Feijó Azevedo
Facility Name
CMiP - Centro Mineiro de Pesquisa
City
Juiz de Fora
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
scafuto.cmip@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Scafuto Scotton
Facility Name
Hospital Bruno Born
City
Lajeado
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
jussarambohn@gmail.com
First Name & Middle Initial & Last Name & Degree
Jussara Marilu Bohn
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
consultorio@tamaramucenic.com.br
First Name & Middle Initial & Last Name & Degree
Tamara Mucenic
Facility Name
Clínica SER da Bahia
City
Salvador
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
mitter.santiago@serdabahia.com.br
First Name & Middle Initial & Last Name & Degree
Mittermayer Barreto Santiago
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa
City
Sao Jose do Rio Preto
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
ma_alvesf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mariana Alves Ferreira Martins
Facility Name
CPCLIN - Centro de Pesquisas Clínicas Ltda.
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
vanessa.reumato@gmail.com
First Name & Middle Initial & Last Name & Degree
Vanessa de Oliveira Magalhaes
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
flora.marcolino@cepic.com.br
First Name & Middle Initial & Last Name & Degree
Flora Maria D'Andrea Marcolino
Facility Name
DCC 'Sveti Georgi' EOOD - Cardiology Office
City
Haskovo
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
iridavasileva@gmail.com
First Name & Middle Initial & Last Name & Degree
Irida Vasileva
Facility Name
Medical center Medconsult Pleven OOD
City
Pleven
Country
Bulgaria
Individual Site Status
Withdrawn
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 - Ruse, EOOD
City
Ruse
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
nely_kap@abv.bg
First Name & Middle Initial & Last Name & Degree
Nadezhda Kapandjieva
Facility Name
Medical Center-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 "Alexandrovska", EOOD
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
drbrezoev@abv.bg
First Name & Middle Initial & Last Name & Degree
Petyo Brezoev
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 - Department of Rheumatology
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 Prof. Dr. Stoyan Kirkovich AD
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Email
dr.aleksieva.tanya@gmail.com
First Name & Middle Initial & Last Name & Degree
Tanya Aleksieva-Petkova Aleksieva-Petkova
Facility Name
Clínica Alemana de Osorno
City
Osorno
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Email
sarriagadah@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Sonia Arriagada Herrera
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
CeCim Biocinetic
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Email
darwin.yanez@cecim.cl
First Name & Middle Initial & Last Name & Degree
Darwin Yañez Pizarro
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 Clínicos - 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
Dermacross
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Email
ccruzf@gmail.com
First Name & Middle Initial & Last Name & Degree
Claudia De La Cruz
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 2nd Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
13973127520@139.com
First Name & Middle Initial & Last Name & Degree
Fen Li
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
yi2006liu@163.com
First Name & Middle Initial & Last Name & Degree
Yi Liu
Facility Name
Guangdong Provincial People's Hospital - Oncology
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
zx1986001306@126.com
First Name & Middle Initial & Last Name & Degree
Xiao Zhang
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
zsuyns@163.com
First Name & Middle Initial & Last Name & Degree
Niansheng Yang
Facility Name
Hainan General Hospital
City
Haikou
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
renal@126.com
First Name & Middle Initial & Last Name & Degree
Feng Zhan
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
13948536552@139.com
First Name & Middle Initial & Last Name & Degree
Hongbin Li
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
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
qianlu5860@pumcderm.cams.cn
First Name & Middle Initial & Last Name & Degree
Qianjin Lu
Facility Name
The Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
lingyunsun2012@163.com
First Name & Middle Initial & Last Name & Degree
Lingyun Sun
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
xxzhu@unirheuma.org
First Name & Middle Initial & Last Name & Degree
Xiaoxia Zhu
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
lu_liangjing@163.com
First Name & Middle Initial & Last Name & Degree
Liangjing Lu
Facility Name
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
jie-zheng2001@126.com
First Name & Middle Initial & Last Name & Degree
Jie Zheng
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
shiyuling1016@163.com
First Name & Middle Initial & Last Name & Degree
Yuling Shi
Facility Name
The First Affiliated Hospital of Soochow University
City
SuZhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
njwujian@163.com
First Name & Middle Initial & Last Name & Degree
Jian Wu
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
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
xajdljn@126.com
First Name & Middle Initial & Last Name & Degree
Lan He
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 CIREEM S.A.S.
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
Servimed S.A.S.
City
Bucaramanga
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
Email
wiotero@gmail.com
First Name & Middle Initial & Last Name & Degree
William Jose Otero Escalante
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
"Andreas Syggros" Hospital - Department of Dermatology
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
dimitrisrigopoulos54@gmail.com
First Name & Middle Initial & Last Name & Degree
Dimitris Rigopoulos
Facility Name
General Hospital of Athens Laiko
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
psfikakis@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Petros Sfikakis
Facility Name
University Hospital of Patra
City
Patra
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
snliossis@med.upatras.gr
First Name & Middle Initial & Last Name & Degree
Stamatios N Liossis
Facility Name
General Hospital of Thessaloniki "Hippokration"
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
garyalex@auth.gr
First Name & Middle Initial & Last Name & Degree
Alexandros Garyfallos
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
Skin and Venereal Diseases' Hospital
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
dem@auth.gr
First Name & Middle Initial & Last Name & Degree
Dimitrios Ioannides
Facility Name
Chaim Sheba Medical Center - pt
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Email
merav.lidar@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Merav Lidar
Facility Name
NHO Asahikawa Medical Center - Dept of Gastroenterology
City
Asahikawa-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
hirano.fuminori.cx@mail.hosp.go.jp
First Name & Middle Initial & Last Name & Degree
Fuminori Hirano
Facility Name
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
City
Chiba-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
ooya.yoshihiro.cw@mail.hosp.go.jp
First Name & Middle Initial & Last Name & Degree
Yoshihiro Oya
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
Hiroshima University Hospital - Dept of Rheumatology/Immunology
City
Hiroshima-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
shirata@hiroshima-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Shintaro Hirata
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
Kanazawa University Hospital - Dept of Rheumatology/Immunology
City
Kanazawa-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
sk33166@gmail.com
First Name & Middle Initial & Last Name & Degree
Mitsuhiro Kawano
Facility Name
Saitama Medical Center - Dept of Rheumatology/Immunology
City
Kawagoe-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
t_kondo@saitama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Tsuneo Kondo
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
Toho University Ohashi Medical Center - Dept of Immunology/Rheumatology
City
Meguro-ku
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
hideto.kameda@med.toho-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Hideto Kameda
Facility Name
Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
City
Sapporo-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
ktmasaru@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Masaru Kato
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
Ehime University Hospital - Dept of Immunology/Rheumatology
City
Toon-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
takuya-m@m.ehime-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Takuya Matsumoto
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
sglee@pnuh.co.kr
First Name & Middle Initial & Last Name & Degree
Seung-Geun Lee
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
baekhj@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Han Joo Baek
Facility Name
Kyung Hee University Hospital at Gangdong:
City
Seoul
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
elee@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eun Young Lee
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
Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista
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
Centro de Estudios de Investigacion Basica y Clinica SC
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
dr.iggv@gmail.com
First Name & Middle Initial & Last Name & Degree
Ignacio Garcia Valladares
Facility Name
Consultorio Médico del Dr. Federico Galván Villegas
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
federico_galvan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Federico Galvan Villegas
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
Citer, Centro de Investigación Y Tratamiento de Las Enfermedades Reumaticas Sa de Cv
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
Clinstile, S.A. de C.V.
City
Mexico
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 de Reumatologia - Hospital Angeles Lindavista Cons. 445B
City
Mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
smcv_1972@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sandra Miriam Carrillo Vazquez
Facility Name
Grupo Medico Camino S.C.
City
Mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
jorge.rojas@gmcamino.com
First Name & Middle Initial & Last Name & Degree
Jorge Rojas Serrano
Facility Name
Centro Regiomontano de Estudios Clínicos Roma S.C.
City
Monterrey
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
dra.iriscolunga@hotmail.com
First Name & Middle Initial & Last Name & Degree
Iris J Colunga Pedraza
Facility Name
AMAF Clinical Research S.C
City
México
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
clinosarinvestigacion@prodigy.net.mx
First Name & Middle Initial & Last Name & Degree
Maria de Jesus Araujo Arias
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
Medical Care & Research SA de CV
City
Yucatan
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
ace283@hotmail.com
First Name & Middle Initial & Last Name & Degree
Aaron Alejandro Barrera Rodriguez
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
Green City Medical Center
City
Angeles City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
drgomez_aufsom@yahoo.com
First Name & Middle Initial & Last Name & Degree
Harold Michael Gomez
Facility Name
Perpetual Succour Hospital
City
Cebu City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
jillt_md@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jill Henriett Mangubat
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
Mary Mediatrix Medical Center
City
Lipa City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
doc_lanzon@yahoo.com
First Name & Middle Initial & Last Name & Degree
Allan E Lanzon
Facility Name
Chinese General Hospital & Medical Center
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
julietanliyu@gmail.com
First Name & Middle Initial & Last Name & Degree
Julie L Li-Yu
Facility Name
Far Eastern University - Dr. Nicanor Reyes Medical Foundation - Department of Child Health
City
Quezon City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
Email
rosariopajarin@yahoo.com
First Name & Middle Initial & Last Name & Degree
Rosario P Baes
Facility Name
Ospital Ng Makati
City
Quezon 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 Spolka Partnerska
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 Medyczne Plejady
City
Krakow
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
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
Twoja Przychodnia Opolskie Centrum Medyczne
City
Opole
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
gjaworska@opolemed.com
First Name & Middle Initial & Last Name & Degree
Grazyna Jaworska-Gorna
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
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
debniak@twojaprzychodnia.com
First Name & Middle Initial & Last Name & Degree
Tadeusz Debniak
Facility Name
Clinical Best Solutions - Warszawa
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
drmariuszsikora@gmail.com
First Name & Middle Initial & Last Name & Degree
Mariusz Sikora
Facility Name
Centrul Medical Monza SRL - Arensia Exploratory Medicine
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
mabobului@gmail.com
First Name & Middle Initial & Last Name & Degree
Mihai Abobului
Facility Name
S.C Delta Health Care S.R.L - Ponderas Academic Hospital
City
Bucuresti
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
b_chicos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Bogdan Horia Chicos
Facility Name
Spitalul Clinic "Sf. Maria" - Clinica de Medicina Interna si Reumatologie
City
Bucuresti
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
balanescu.andra@gmail.com
First Name & Middle Initial & Last Name & Degree
Andra-Rodica Balanescu
Facility Name
Spitalul Clinic "Sf. Maria" - parent
City
Bucuresti
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
berghea1@gmail.com
First Name & Middle Initial & Last Name & Degree
Florian Berghea
Facility Name
Spitalul Clinic Colentina - parent
City
Bucuresti
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
tane67@gmail.com
First Name & Middle Initial & Last Name & Degree
Razvan Adrian Ionescu
Facility Name
Sc Medaudio-Optica SRL
City
Ramnicu Valcea
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
razvan1us@yahoo.com
First Name & Middle Initial & Last Name & Degree
Razvan Constantin Ionitescu
Facility Name
Institute of Rheumatology- 1
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Email
g.radunovic47@gmail.com
First Name & Middle Initial & Last Name & Degree
Goran Radunovic
Facility Name
Institute of Rheumatology-1
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
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
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
University Clinical Center Kragujevac
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Email
miraveselinovic.m@gmail.com
First Name & Middle Initial & Last Name & Degree
Mirjana Veselinovic
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
University of Pretoria Clinical Research Unit - Parent
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
Email
tar@up.ac.za
First Name & Middle Initial & Last Name & Degree
Mahmood M Ally
Facility Name
Naidoo, A - Netcare Umhlanga Hospital
City
Umhlanga
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Hospital General de Castellon - Servicio de Reumatologia
City
Castellón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
arantxaconesa@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maria Arantzazu Conesa Mateos
Facility Name
Complejo Hospitalario Universitario A Coruña - Servicio de Reumatologia
City
La Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
fblagar@sergas.es
First Name & Middle Initial & Last Name & Degree
Francisco Javier Blanco Garcia
Facility Name
Hospital Universitario 12 de Octubre - Servicio de Reumatologia
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
mgalindo@h12o.es
First Name & Middle Initial & Last Name & Degree
Maria Galindo Izquierdo
Facility Name
Hospital Regional Universitario de Malaga - Reumatology Dept
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
afernandezn@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Fernandez Nebro
Facility Name
Hospital Universitario Marques de Valdecilla - Servicio de Reumatologia
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
ricardo.blanco@scsalud.es
First Name & Middle Initial & Last Name & Degree
Ricardo Blanco Alonso
Facility Name
Hospital Quironsalud Sagrado Corazon - Reumatologia
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
pcejashil@gmail.com
First Name & Middle Initial & Last Name & Degree
Paula Cejas Caceres
Facility Name
Hospital Universitario Dr. Peset - Servicio de Reumatologia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
alegre_juasan@gva.es
First Name & Middle Initial & Last Name & Degree
Juan Jose Alegre Sancho
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
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
jichenho@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Ji Chen Ho
Facility Name
Taipei Veterans General Hospital
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
ytchang@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Yun-Ting Chang
Facility Name
Cheng Hsin General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
doc1116d@gmail.com
First Name & Middle Initial & Last Name & Degree
Hsiao-Yi Lin

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_0003
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

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