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A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

Primary Purpose

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB059 (litifilimab)
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacute Cutaneous Lupus Erythematosus focused on measuring Cutaneous Lupus Erythematosus (CLE), Acute Cutaneous Lupus Erythematosus (ACLE), Discoid Lupus Erythematosus (DLE), Systemic Lupus Erythematosus (SLE), Lupus

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Histologically confirmed (in the past or at Screening) diagnosis of CLE with or without systemic manifestations.
  2. Must have active cutaneous manifestations that meet study criteria.
  3. Must have a CLASI-A score ≥10.
  4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key Exclusion Criteria:

  1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
  2. Active severe lupus nephritis.
  3. Active neuropsychiatric SLE.
  4. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • Pinnacle Research Group, LLCRecruiting
  • UAB Center for Women's Reproductive HealthRecruiting
  • Arizona Arthritis & Rheumatology Research, PLLCRecruiting
  • Dermatology Research AssociatesRecruiting
  • Clinical Science InstituteRecruiting
  • Inland Rheumatology Clinical Trials, Inc.Recruiting
  • Denver Arthritis ClinicRecruiting
  • Omega Research Debary, LLCRecruiting
  • Centre for Rheumatology, Immunology and ArthritisRecruiting
  • University of FloridaRecruiting
  • Charisma Medical and Research CenterRecruiting
  • University of Miami Miller School of MedicineRecruiting
  • Medical Research Center of Miami
  • OrthoIllinoisRecruiting
  • Dawes Fretzin Dermatology Group, LLCRecruiting
  • Brigham And Women's HospitalRecruiting
  • Essential DermatologyRecruiting
  • Beacon Clinical Research, LLCRecruiting
  • University of Massachusetts, WorcesterRecruiting
  • David Fivenson, MD, Dermatology, PLLCRecruiting
  • Oakland Hills DermatologyRecruiting
  • AA MRC LLC Ahmed Arif Medical Research CenterRecruiting
  • Revival Research Institute, LLCRecruiting
  • Saint Louis UniversityRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Albuquerque Center For RheumatologyRecruiting
  • University of New Mexico School of MedicineRecruiting
  • NYU Langone BrooklynRecruiting
  • Universal Dermatology, PLLCRecruiting
  • Northwell Health, Inc. PRIMERecruiting
  • University of North Carolina at Chapel HillRecruiting
  • Duke Dermatology South DurhamRecruiting
  • Medication Management, LLC
  • University of Cincinnati Department of DermatologyRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Ohio State UniversityRecruiting
  • Penn State University Milton S. Hershey Medical CenterRecruiting
  • University of PennsylvaniaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Austin Regional Clinic, P.A.Recruiting
  • Precision Comprehensive Clinical Research SolutionsRecruiting
  • Metroplex Clinical Research Center, LLCRecruiting
  • UT Southwestern Medical CenterRecruiting
  • North Texas Center for Clinical ResearchRecruiting
  • UTMB Department of DermatologyRecruiting
  • Arthritis & Osteoporosis ClinicRecruiting
  • University of Utah Health Sciences CenterRecruiting
  • West End Dermatology AssociatesRecruiting
  • CINME - Centro De Investigaciones MetabolicasRecruiting
  • Centro de Investigaciones Medicas Mar del PlataRecruiting
  • Instituto de Investigaciones Clinicas QuilmesRecruiting
  • APRILLUS Asistencia e InvestigacionRecruiting
  • Fundacion RespirarRecruiting
  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRLRecruiting
  • Centro de Investigaciones Medicas TucumanRecruiting
  • Investigaciones Clinicas TucumanRecruiting
  • Hospital Italiano de La PlataRecruiting
  • Centro Privado de Medicina Familiar - Mind Out ResearchRecruiting
  • Clinica Adventista BelgranoRecruiting
  • Instituto de ReumatologiaRecruiting
  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do CearáRecruiting
  • L2IP - Instituto de Pesquisas Clínicas Ltda.Recruiting
  • CEDOES - Diagnóstico e PesquisaRecruiting
  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/ARecruiting
  • Hospital Bruno BornRecruiting
  • Nucleo de Pesquisa Clinica do Rio Grande do SulRecruiting
  • CEMEC - Centro Multidisciplinar de Estudos ClínicosRecruiting
  • CEPIC - Centro Paulista de Investigação Clínica e Serviços MédicosRecruiting
  • Medical center Medconsult Pleven OODRecruiting
  • UMHAT 'Dr. Georgi Stranski', EADRecruiting
  • DCC 1 - Ruse, EOODRecruiting
  • DCC 'Alexandrovska', EOODRecruiting
  • DCC Focus 5 - MEOH OODRecruiting
  • DCC Focus 5 - MEOH OODRecruiting
  • Military Medical Academy - MHAT - SofiaRecruiting
  • Dermatology Clinic of Dr. Michael RobernRecruiting
  • Medicor Research IncRecruiting
  • DIEX Recherche Sherbrooke Inc.Recruiting
  • DermacrossRecruiting
  • BioMedica Research GroupRecruiting
  • CIEC - Centro Internacional de Estudios ClínicosRecruiting
  • Clinical Research Chile SpA.Recruiting
  • Oncocentro APYSRecruiting
  • CHU Nice - Hopital de l ArchetRecruiting
  • Hôpital de la TimoneRecruiting
  • CHU de Caen - Hopital de la Cote de NacreRecruiting
  • CHU Besançon - Hôpital Jean MinjozRecruiting
  • Hopital LarreyRecruiting
  • Hôpital Privé d'AntonyRecruiting
  • Hopital Saint EloiRecruiting
  • Hôpital Saint-LouisRecruiting
  • Hopital Edouard Herriot - CHU LyonRecruiting
  • Hopital TenonRecruiting
  • Universitaetsklinikum ErlangenRecruiting
  • Fachklinik Bad Bentheim DermatologieRecruiting
  • Elbekliniken Buxtehude GmbHRecruiting
  • Klinikum Oldenburg AoeRRecruiting
  • Universitaetsklinikum MuensterRecruiting
  • Universitaetsklinikum Halle (Saale)Recruiting
  • Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
  • Universitaetsklinikum Schleswig-Holstein - Campus KielRecruiting
  • Charité - Campus Charité MitteRecruiting
  • Pecsi TudomanyegyetemRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCSRecruiting
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)Recruiting
  • Università degli studi di FirenzeRecruiting
  • IRCCS Ospedale Policlinico San MartinoRecruiting
  • Fondazione IRCCS CA' Granda Ospedale Maggiore PoliclinicoRecruiting
  • Polyclinic Federico IIRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
  • University of Fukui HospitalRecruiting
  • Kita Harima Medical CenterRecruiting
  • Niigata University Medical & Dental HospitalRecruiting
  • Korea University Ansan HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Clinstile, S.A. de C.V.Recruiting
  • Centro de Investigacion Clínica GRAMEL S.CRecruiting
  • Consultorio Privado Dr. Miguel Cortes HernandezRecruiting
  • Medical Care & Research SA de CVRecruiting
  • Investigacion y Biomedicina de Chihuahua, S.C.Recruiting
  • Cebu Doctors University HospitalRecruiting
  • Mary Mediatrix Medical CenterRecruiting
  • St. Luke's Medical CenterRecruiting
  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek BrzewskiRecruiting
  • SPZOZ Szpital Uniwersytecki w KrakowieRecruiting
  • Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A LesiakRecruiting
  • Kliniczny Szpital Wojewodzki nr 1 im.F.ChopinaRecruiting
  • RoyaldermRecruiting
  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka PartnerskaRecruiting
  • Hospital de Egas MonizRecruiting
  • Hospital CUF DescobertasRecruiting
  • Centro Hospitalar Universitártio do Porto, E.P.E.Recruiting
  • Unidade Local de Saúde do Alto Minho, E.P.E.Recruiting
  • Dr. Samuel Sanchez PSCRecruiting
  • GCM Medical Group PSC - Hato ReyRecruiting
  • Institute of RheumatologyRecruiting
  • University Clinical Center of SerbiaRecruiting
  • Artromac n.o.Recruiting
  • Narodny ustav reumatickych chorobRecruiting
  • Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitario Rio HortegaRecruiting
  • Hospital Universitario Fundacion AlcorconRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Hospital del MarRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Complejo Hospitalario Universitario A CoruñaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Karolinska Universitetssjukhuset - SolnaRecruiting
  • Centre Hospitalier Universitaire Vaudois (CHUV)Recruiting
  • Kantonsspital St. GallenRecruiting
  • Changhua Christian Medical Foundation Changhua Christian HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Whipps Cross University HospitalRecruiting
  • Manchester Royal InfirmaryRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Chapel Allerton HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part A (Phase 2): BIIB059

Part A (Phase 2): Placebo

Part B (Phase 3): BIIB059

Part B (Phase 3): Placebo

Arm Description

Participants will receive BIIB059 subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.

Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.

Participants will receive BIIB059 SC Q4W from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.

Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.

Outcomes

Primary Outcome Measures

Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline

Secondary Outcome Measures

Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline
Part A (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score
Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline
Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline
Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score
Part B (US+ROW): Absolute Change in CLASI-D Score
Part B (US+ROW): Percent Change in CLASI-D Score
Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0
Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3
Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A
Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A
Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score
Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC Treatment Period (TP)
Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 and 24, Respectively, who Were Assigned to Receive BIIB059 in DBPC TP
Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 in DBPC TP
Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Parts A, B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP
Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Parts A and B(US+ROW): Percentage of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP
Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24
Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16
Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52
Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Parts A and B (US+ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Study

Full Information

First Posted
August 19, 2022
Last Updated
October 6, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT05531565
Brief Title
A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
Acronym
AMETHYST
Official Title
A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
July 13, 2026 (Anticipated)
Study Completion Date
December 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

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 primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].
Detailed Description
BIIB059 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2 and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Keywords
Cutaneous Lupus Erythematosus (CLE), Acute Cutaneous Lupus Erythematosus (ACLE), Discoid Lupus Erythematosus (DLE), Systemic Lupus Erythematosus (SLE), Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A (Phase 2): BIIB059
Arm Type
Experimental
Arm Description
Participants will receive BIIB059 subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
Arm Title
Part A (Phase 2): Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
Arm Title
Part B (Phase 3): BIIB059
Arm Type
Experimental
Arm Description
Participants will receive BIIB059 SC Q4W from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
Arm Title
Part B (Phase 3): Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
Intervention Type
Drug
Intervention Name(s)
BIIB059 (litifilimab)
Other Intervention Name(s)
litifilimab
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Time Frame
Week 16
Title
Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline
Time Frame
Weeks 16 and 24
Title
Part A (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score
Time Frame
Baseline to Week 52
Title
Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline
Time Frame
Weeks 16 and 24
Title
Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline
Time Frame
Weeks 16 and 24
Title
Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score
Time Frame
Up to Week 24
Title
Part B (US+ROW): Absolute Change in CLASI-D Score
Time Frame
Week 52
Title
Part B (US+ROW): Percent Change in CLASI-D Score
Time Frame
Week 52
Title
Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
Time Frame
Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Title
Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time Frame
Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Title
Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline
Time Frame
Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1
Time Frame
Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline
Time Frame
Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0
Time Frame
Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score
Time Frame
Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0
Time Frame
Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1
Time Frame
Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3
Time Frame
Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A
Time Frame
Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A
Time Frame
Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score
Time Frame
Up to Week 24
Title
Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC Treatment Period (TP)
Time Frame
Week 52
Title
Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
Time Frame
Week 52
Title
Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 and 24, Respectively, who Were Assigned to Receive BIIB059 in DBPC TP
Time Frame
Week 52
Title
Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
Time Frame
Week 52
Title
Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 in DBPC TP
Time Frame
Week 52
Title
Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Time Frame
Week 52
Title
Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Time Frame
Week 52
Title
Parts A, B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP
Time Frame
Week 52
Title
Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Time Frame
Week 52
Title
Parts A and B(US+ROW): Percentage of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP
Time Frame
Week 52
Title
Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24
Time Frame
Up to Week 24
Title
Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16
Time Frame
Up to Week 16
Title
Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52
Time Frame
Up to Week 52
Title
Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
Up to Week 76
Title
Parts A and B (US+ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Study
Time Frame
Up to Week 76

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations. Must have active cutaneous manifestations that meet study criteria. Must have a CLASI-A score ≥10. Must have an active CLE lesion despite an adequate trial of antimalarial treatment. Key Exclusion Criteria: Any active skin conditions other than CLE that may interfere with the study assessments of CLE. Active severe lupus nephritis. Active neuropsychiatric SLE. Use of intralesional corticosteroids within 1 week prior to Screening and during the study. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
256-236-0055
First Name & Middle Initial & Last Name & Degree
Vishala L Chindalore
Facility Name
UAB Center for Women's Reproductive Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-7340
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
205-502-9960
First Name & Middle Initial & Last Name & Degree
Lauren Graham
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
480-443-8400
First Name & Middle Initial & Last Name & Degree
Saima Chohan
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-337-7171
First Name & Middle Initial & Last Name & Degree
Howard Lee Sofen
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-828-8887
First Name & Middle Initial & Last Name & Degree
Paul Yamauchi
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
909-296-8700
First Name & Middle Initial & Last Name & Degree
Eric Cheng-Jer Lee
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
303-394-2828
First Name & Middle Initial & Last Name & Degree
Christopher Ryan Antolini
Facility Name
Omega Research Debary, LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-988-1075
First Name & Middle Initial & Last Name & Degree
Kwabena Ayesu
Facility Name
Centre for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-229-0425
First Name & Middle Initial & Last Name & Degree
Yvonne R. Sherrer
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-5340
First Name & Middle Initial & Last Name & Degree
Michael R Bubb
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:
Phone
305-244-7639
First Name & Middle Initial & Last Name & Degree
Marimer Rensoli Velazquez
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-542-3535
First Name & Middle Initial & Last Name & Degree
Andrea Dale Maderal
Facility Name
Medical Research Center of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Completed
Facility Name
OrthoIllinois
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
779-774-1261
First Name & Middle Initial & Last Name & Degree
Amrit Anand
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:
Phone
3175165030102
First Name & Middle Initial & Last Name & Degree
Scott A. Fretzin
Facility Name
Brigham And Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-732-6378
First Name & Middle Initial & Last Name & Degree
Joseph F. Merola
Facility Name
Essential Dermatology
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
508-827-2615
First Name & Middle Initial & Last Name & Degree
Michael S Krathen
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
781-253-7165
First Name & Middle Initial & Last Name & Degree
Victoria Kuohung
Facility Name
University of Massachusetts, Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
774-455-4759
First Name & Middle Initial & Last Name & Degree
Mehdi Rashighi
Facility Name
David Fivenson, MD, Dermatology, PLLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
734-712-3376
First Name & Middle Initial & Last Name & Degree
David P Fivenson
Facility Name
Oakland Hills Dermatology
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
248-858-2255
First Name & Middle Initial & Last Name & Degree
Christofer Buatti
Facility Name
AA MRC LLC Ahmed Arif Medical Research Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
810-694-0082
First Name & Middle Initial & Last Name & Degree
Ali A. Karrar
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
248-590-0298
First Name & Middle Initial & Last Name & Degree
Ali Moiin
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
314-256-3454
First Name & Middle Initial & Last Name & Degree
M Yadira Hurley
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
402-559-4000
First Name & Middle Initial & Last Name & Degree
Megan R Arthur
Facility Name
Albuquerque Center For Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
505-242-6190
First Name & Middle Initial & Last Name & Degree
Leroy A Pacheco
Facility Name
University of New Mexico School of Medicine
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
505-272-6000
First Name & Middle Initial & Last Name & Degree
Nikifor F Konstantinov
Facility Name
NYU Langone Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
929-455-2399
First Name & Middle Initial & Last Name & Degree
David Harry Goddard
Facility Name
Universal Dermatology, PLLC
City
Fairport
State/Province
New York
ZIP/Postal Code
14450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
585-275-7546
First Name & Middle Initial & Last Name & Degree
Brian Poligone
Facility Name
Northwell Health, Inc. PRIME
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
516-708-2557
First Name & Middle Initial & Last Name & Degree
Richard A Furie
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-843-6619
First Name & Middle Initial & Last Name & Degree
Saira Zafar Sheikh
Facility Name
Duke Dermatology South Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-385-7546
First Name & Middle Initial & Last Name & Degree
Anne Louise Marano
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Completed
Facility Name
University of Cincinnati Department of Dermatology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
513-232-1253
First Name & Middle Initial & Last Name & Degree
Debra L Breneman
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
216-844-7164
First Name & Middle Initial & Last Name & Degree
Neil James Korman
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
614-293-1707
First Name & Middle Initial & Last Name & Degree
Benjamin Kaffenberger
Facility Name
Penn State University Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
717-531-1513
First Name & Middle Initial & Last Name & Degree
Joslyn Renee Sciacca Kirby
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
215-615-2940
First Name & Middle Initial & Last Name & Degree
Victoria Patricia Werth
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
615-936-4072
First Name & Middle Initial & Last Name & Degree
Narender Annapureddy
Facility Name
Austin Regional Clinic, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-344-0362
First Name & Middle Initial & Last Name & Degree
Tina C. Bunch
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:
Phone
972-299-8399
First Name & Middle Initial & Last Name & Degree
Dhiman Basu
Facility Name
Metroplex Clinical Research Center, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-879-6737
First Name & Middle Initial & Last Name & Degree
Stanley Bruce Cohen
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8896
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-645-2400
First Name & Middle Initial & Last Name & Degree
Benjamin Chong
Facility Name
North Texas Center for Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
888-635-0552
First Name & Middle Initial & Last Name & Degree
Timothy Gale Rodgers
Facility Name
UTMB Department of Dermatology
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0583
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
409-772-5047
First Name & Middle Initial & Last Name & Degree
Bernard R Gibson
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
254-755-4584
First Name & Middle Initial & Last Name & Degree
HS Eugene Fung
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
801-581-2955
First Name & Middle Initial & Last Name & Degree
Jamie W. Rhoads
Facility Name
West End Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
804-270-6100
First Name & Middle Initial & Last Name & Degree
Yvonne Knight
Facility Name
CINME - Centro De Investigaciones Metabolicas
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541139897342
First Name & Middle Initial & Last Name & Degree
Ricardo Luis Galimberti
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5492235603218
First Name & Middle Initial & Last Name & Degree
Gladys Alicia Testa
Facility Name
Instituto de Investigaciones Clinicas Quilmes
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5491135804733
First Name & Middle Initial & Last Name & Degree
Jose Luis Velasco Zamora
Facility Name
APRILLUS Asistencia e Investigacion
City
Ciudad Autonoma de Buenos Aires
State/Province
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1406AGA
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541567415099
First Name & Middle Initial & Last Name & Degree
Pablo Alejandro Mannucci Walter
Facility Name
Fundacion Respirar
City
Ciudad Autonoma de Buenos Aires
State/Province
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541167063598
First Name & Middle Initial & Last Name & Degree
Alejandro Arroyo
Facility Name
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
543814304423
First Name & Middle Initial & Last Name & Degree
Francisco Colombres
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
543814200180
First Name & Middle Initial & Last Name & Degree
Walter Javier Spindler
Facility Name
Investigaciones Clinicas Tucuman
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000ICL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5493815932070
First Name & Middle Initial & Last Name & Degree
Veronica Ines Bellomio
Facility Name
Hospital Italiano de La Plata
City
Buenos Aires
ZIP/Postal Code
B1900AXI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
542214176839
First Name & Middle Initial & Last Name & Degree
Rodrigo Nicolas Garcia Salinas
Facility Name
Centro Privado de Medicina Familiar - Mind Out Research
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1417
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5491149273479
First Name & Middle Initial & Last Name & Degree
Leonardo Naftal
Facility Name
Clinica Adventista Belgrano
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541145445522
First Name & Middle Initial & Last Name & Degree
Federico Javier Ariel
Facility Name
Instituto de Reumatologia
City
Mendoza
ZIP/Postal Code
M5500
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5492615440980
First Name & Middle Initial & Last Name & Degree
Alfredo Borgia
Facility Name
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-370
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
5585991711566
First Name & Middle Initial & Last Name & Degree
Vanessa Beatriz de Vasconcelos Marques
Facility Name
L2IP - Instituto de Pesquisas Clínicas Ltda.
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
556134454300
First Name & Middle Initial & Last Name & Degree
Eduardo Freire Vasconcellos
Facility Name
CEDOES - Diagnóstico e Pesquisa
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
552721250223
First Name & Middle Initial & Last Name & Degree
Valquiria Garcia Dinis
Facility Name
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
City
Rio de Janeiro
State/Province
Rio Do Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
552125277979
First Name & Middle Initial & Last Name & Degree
Jaqueline Barbeito de Vasconcellos
Facility Name
Hospital Bruno Born
City
Lajeado
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95900-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
555137147500
First Name & Middle Initial & Last Name & Degree
Jussara Marilu Bohn
Facility Name
Nucleo de Pesquisa Clinica do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
555137796400
First Name & Middle Initial & Last Name & Degree
Cecilia Viola Varella da Costa
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
Sao Bernardo Do Campo
State/Province
Sao Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551149304243
First Name & Middle Initial & Last Name & Degree
Paulo Ricardo Criado
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551122713450
First Name & Middle Initial & Last Name & Degree
Flora Maria D'Andrea Marcolino
Facility Name
Medical center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359888595463
First Name & Middle Initial & Last Name & Degree
Kamelia Vekovska
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359878310287
First Name & Middle Initial & Last Name & Degree
Dimitar Gospodinov
Facility Name
DCC 1 - Ruse, EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359888411725
First Name & Middle Initial & Last Name & Degree
Nadezhda Kapandjieva
Facility Name
DCC 'Alexandrovska', EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359888208421
First Name & Middle Initial & Last Name & Degree
Petyo Brezoev
Facility Name
DCC Focus 5 - MEOH OOD
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359898655448
First Name & Middle Initial & Last Name & Degree
Grisha Mateev
Facility Name
DCC Focus 5 - MEOH OOD
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359887312219
First Name & Middle Initial & Last Name & Degree
Rumen Stoilov
Facility Name
Military Medical Academy - MHAT - Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359888985531
First Name & Middle Initial & Last Name & Degree
Boycho Oparanov
Facility Name
Dermatology Clinic of Dr. Michael Robern
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
5195760768315
First Name & Middle Initial & Last Name & Degree
Michael R. Robern
Facility Name
Medicor Research Inc
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 1X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
7055660005
First Name & Middle Initial & Last Name & Degree
Lyne Giroux
Facility Name
DIEX Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
8193462887
First Name & Middle Initial & Last Name & Degree
Daniel Minier
Facility Name
Dermacross
City
Santiago
ZIP/Postal Code
66901
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Phone
56229540251
First Name & Middle Initial & Last Name & Degree
Claudia Paz De La Cruz
Facility Name
BioMedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Phone
56992323955
First Name & Middle Initial & Last Name & Degree
Elizabeth Jean Moreno Goio
Facility Name
CIEC - Centro Internacional de Estudios Clínicos
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Phone
56227357954
First Name & Middle Initial & Last Name & Degree
Fernando Valenzuela
Facility Name
Clinical Research Chile SpA.
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Phone
56940601237
First Name & Middle Initial & Last Name & Degree
Alvaro Andres San Martin Leal
Facility Name
Oncocentro APYS
City
Viña del Mar
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
Phone
56322675546
First Name & Middle Initial & Last Name & Degree
Renato Eduardo Jimenez Calabrese
Facility Name
CHU Nice - Hopital de l Archet
City
Nice cedex 3
State/Province
Alpes Maritimes
ZIP/Postal Code
6200
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33492036070
First Name & Middle Initial & Last Name & Degree
Florence Le Duff
Facility Name
Hôpital de la Timone
City
Marseille cedex 5
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33491387991
First Name & Middle Initial & Last Name & Degree
Marie-Aleth Richard
Facility Name
CHU de Caen - Hopital de la Cote de Nacre
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33231272510
First Name & Middle Initial & Last Name & Degree
Diane Kottler
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33381218102
First Name & Middle Initial & Last Name & Degree
Julie Castagna
Facility Name
Hopital Larrey
City
Toulouse Cedex 9
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33567778135
First Name & Middle Initial & Last Name & Degree
Cristina Bulai Livideanu
Facility Name
Hôpital Privé d'Antony
City
Antony
State/Province
Hauts De Seine
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33146744489
First Name & Middle Initial & Last Name & Degree
Pierre-Andre Becherel
Facility Name
Hopital Saint Eloi
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33467336906
First Name & Middle Initial & Last Name & Degree
Didier Bessis
Facility Name
Hôpital Saint-Louis
City
Cedex 10
State/Province
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33142499961
First Name & Middle Initial & Last Name & Degree
Jean-David Bouaziz
Facility Name
Hopital Edouard Herriot - CHU Lyon
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33472110321
First Name & Middle Initial & Last Name & Degree
Cecile Lesort
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33156017221
First Name & Middle Initial & Last Name & Degree
Francois Chasset
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4991318533851
First Name & Middle Initial & Last Name & Degree
Michael Sticherling
Facility Name
Fachklinik Bad Bentheim Dermatologie
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
495922745270
First Name & Middle Initial & Last Name & Degree
Athanasios Tsianakas
Facility Name
Elbekliniken Buxtehude GmbH
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4941617036005
First Name & Middle Initial & Last Name & Degree
Andreas Kleinheinz
Facility Name
Klinikum Oldenburg AoeR
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4944140372854
First Name & Middle Initial & Last Name & Degree
Nikolaos Patsinakidis
Facility Name
Universitaetsklinikum Muenster
City
Muenster
State/Province
Nordrhein Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
492518356501
First Name & Middle Initial & Last Name & Degree
Kerstin Steinbrink
Facility Name
Universitaetsklinikum Halle (Saale)
City
Halle
State/Province
Sachsen Anhalt
ZIP/Postal Code
6120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
493455573933
First Name & Middle Initial & Last Name & Degree
Johannes Wohlrab
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
493514582344
First Name & Middle Initial & Last Name & Degree
Claudia Guenther
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4943150021200
First Name & Middle Initial & Last Name & Degree
Guido Heine
Facility Name
Charité - Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4930450518105
First Name & Middle Initial & Last Name & Degree
Margitta Worm
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
3639161691
First Name & Middle Initial & Last Name & Degree
Anita Hanyecz
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
39512144847
First Name & Middle Initial & Last Name & Degree
Michelangelo La Placa
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
39303995307
First Name & Middle Initial & Last Name & Degree
Piergiacomo Calzavara Pinton
Facility Name
Università degli studi di Firenze
City
Firenze
ZIP/Postal Code
50121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
39556939670
First Name & Middle Initial & Last Name & Degree
Marzia Caproni
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
393472752976
First Name & Middle Initial & Last Name & Degree
Aurora Parodi
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
39255036289
First Name & Middle Initial & Last Name & Degree
Angelo Valerio Marzano
Facility Name
Polyclinic Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
39817462450
First Name & Middle Initial & Last Name & Degree
Paola Nappa
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
137
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
39630154798
First Name & Middle Initial & Last Name & Degree
Clara De Simone
Facility Name
University of Fukui Hospital
City
Yoshida-gun
State/Province
Fukui-Ken
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kita Harima Medical Center
City
Ono-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
675-1392
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata-shi
State/Province
Niigata-Ken
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
4763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinstile, S.A. de C.V.
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
6700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
525552561496
First Name & Middle Initial & Last Name & Degree
Favio Edmundo Enriquez Sosa
Facility Name
Centro de Investigacion Clínica GRAMEL S.C
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
3720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
525544274848
First Name & Middle Initial & Last Name & Degree
Luis Javier Jara Quezada
Facility Name
Consultorio Privado Dr. Miguel Cortes Hernandez
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62448
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
527773137932
First Name & Middle Initial & Last Name & Degree
Miguel Cortes Hernandez
Facility Name
Medical Care & Research SA de CV
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
529993226891
First Name & Middle Initial & Last Name & Degree
Aaron Alejandro Barrera Rodriguez
Facility Name
Investigacion y Biomedicina de Chihuahua, S.C.
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5216141961278
First Name & Middle Initial & Last Name & Degree
Cesar Francisco Pacheco Tena
Facility Name
Cebu Doctors University Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Mary Mediatrix Medical Center
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Individual Site Status
Recruiting
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48122673560
First Name & Middle Initial & Last Name & Degree
Pawel Brzewski
Facility Name
SPZOZ Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48124247400
First Name & Middle Initial & Last Name & Degree
Anna Wojas-Pelc
Facility Name
Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48692065698
First Name & Middle Initial & Last Name & Degree
Joanna Narbutt
Facility Name
Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48717842292
First Name & Middle Initial & Last Name & Degree
Adam Andrzej Reich
Facility Name
Royalderm
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48601316460
First Name & Middle Initial & Last Name & Degree
Witold Owczarek
Facility Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48713270999
First Name & Middle Initial & Last Name & Degree
Jacek Szepietowski
Facility Name
Hospital de Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
Phone
351210431000
First Name & Middle Initial & Last Name & Degree
Fernando Pimentel Dos Santos
Facility Name
Hospital CUF Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
Phone
351210025200
First Name & Middle Initial & Last Name & Degree
Pedro Mendes Bastos
Facility Name
Centro Hospitalar Universitártio do Porto, E.P.E.
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
Phone
351222077500
First Name & Middle Initial & Last Name & Degree
Alexandra Azevedo
Facility Name
Unidade Local de Saúde do Alto Minho, E.P.E.
City
Viana do Castelo
ZIP/Postal Code
4904-858
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
Phone
351258909500
First Name & Middle Initial & Last Name & Degree
Vera Teixeira
Facility Name
Dr. Samuel Sanchez PSC
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7875985853
First Name & Middle Initial & Last Name & Degree
Samuel Sanchez Rivera
Facility Name
GCM Medical Group PSC - Hato Rey
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7879362100
First Name & Middle Initial & Last Name & Degree
Jose R Gonzalez Chavez
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
381113600801
First Name & Middle Initial & Last Name & Degree
Goran Radunovic
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
381113663700
First Name & Middle Initial & Last Name & Degree
Snezana Arandjelovic
Facility Name
Artromac n.o.
City
Kosice
ZIP/Postal Code
4011
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421911900704
First Name & Middle Initial & Last Name & Degree
Zelmira Macejova
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
92112
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421337969111
First Name & Middle Initial & Last Name & Degree
Olga Lukacova
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34934978813
First Name & Middle Initial & Last Name & Degree
Isabel Bielsa
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
State/Province
Cantabria
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34983420400
First Name & Middle Initial & Last Name & Degree
Maria Julia Barbado Ajo
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34916219647
First Name & Middle Initial & Last Name & Degree
Jose Luis Lopez Estebaranz
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34911916481
First Name & Middle Initial & Last Name & Degree
Rita Cabeza Martinez
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34932483380
First Name & Middle Initial & Last Name & Degree
Ramon Maria Pujol Vallverdu
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34935537007
First Name & Middle Initial & Last Name & Degree
Esther Roe Crespo
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34606887057
First Name & Middle Initial & Last Name & Degree
Juan Alberto Ruano Ruiz
Facility Name
Complejo Hospitalario Universitario A Coruña
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34981176399
First Name & Middle Initial & Last Name & Degree
Francisco Javier Blanco Garcia
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34955014357
First Name & Middle Initial & Last Name & Degree
Noemi Patricia Garrido Punal
Facility Name
Karolinska Universitetssjukhuset - Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
46851770000
First Name & Middle Initial & Last Name & Degree
Filippa Nyberg
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lucerne (Luzern)
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
Phone
41213140351
First Name & Middle Initial & Last Name & Degree
Michel Gilliet
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
Phone
41714942030
First Name & Middle Initial & Last Name & Degree
Antonio Cozzio
Facility Name
Changhua Christian Medical Foundation Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
4420853955226730
First Name & Middle Initial & Last Name & Degree
Anthony Bewley
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
441612761234
First Name & Middle Initial & Last Name & Degree
Benjamin J Parker
Facility Name
Queen Elizabeth Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
441216272000
First Name & Middle Initial & Last Name & Degree
Agustin Martin-Clavijo
Facility Name
Chapel Allerton Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
441133924357
First Name & Middle Initial & Last Name & Degree
Philip M Laws

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org

Learn more about this trial

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

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