Clinical trial NCT05531565: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: 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
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

The main questions researchers want to answer are:

* How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
* How many participants have their skin disease activity go down by at least 70%?

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.

The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:

* After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
* Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
* The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
* During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
* After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
* The total study duration for participants will be up to 80 weeks

Detailed description: Litifilimab 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. The primary objectives of the study are to evaluate the efficacy of litifilimab compared with placebo in reducing skin disease activity measured by the 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 litifilimab in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of litifilimab in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of litifilimab \[Parts A and B\].

Eligibility criteria: Key Inclusion Criteria:

1. Histologically confirmed (in the past or during the Screening period) 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. Diagnosis of mixed connective tissue disease \[(within 1 year of signing the informed consent form (ICF)\] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
3. Active severe lupus nephritis.
4. Active neuropsychiatric SLE.
5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
6. 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

Primary outcomes:
measure: 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
timeFrame: Week 16
measure: 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
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline
timeFrame: Weeks 16 and 24
measure: Part A (US+ROW): Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52
timeFrame: Baseline to Week 52
measure: Part A (US+ROW): Percent Change in CLASI-D Score
timeFrame: Baseline to Week 52
measure: 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 Other OMC Score ≥3 at Baseline
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score
timeFrame: Up to Week 24
measure: Part B (US+ROW): Absolute Change in CLASI-D Score
timeFrame: Week 52
measure: Part B (US+ROW): Percent Change in CLASI-D Score
timeFrame: Week 52
measure: Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
timeFrame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
measure: Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
measure: Part B (US+ROW): Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash
timeFrame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
measure: Part B (US+ROW): Change From Baseline in NRS for Itch in Skin Rash
timeFrame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
measure: 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
timeFrame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1
timeFrame: Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24
measure: 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
timeFrame: 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
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0
timeFrame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score
timeFrame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0
timeFrame: Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1
timeFrame: Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3
timeFrame: Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 70 Response
timeFrame: Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 50 Response
timeFrame: Up to Week 24
measure: Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score
timeFrame: Up to Week 24
measure: 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 Litifilimab During the DBPC Treatment Period (TP)
timeFrame: Week 52
measure: 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 Litifilimab During the DBPC TP
timeFrame: Week 52
measure: Parts A and B(US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0/1 & at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 &24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP
timeFrame: Week 52
measure: Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During DBPC TP
timeFrame: Week 52
measure: 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 Litifilimab in DBPC TP
timeFrame: Week 52
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Week 52
measure: Parts A and B (US+ROW): Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study
timeFrame: Up to Week 76
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Up to Week 24
measure: Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16
timeFrame: Up to Week 16
measure: Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52
timeFrame: Up to Week 52
measure: Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 76
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: UAB Center for Women's Reproductive Health
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: La Jolla
country: United States
facility: The Regents of the University of California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: DeBary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Lakes
country: United States
facility: Charisma Medical and Research Center
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center Shreveport
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham And Women's Hospital
state: Massachusetts
city: Natick
country: United States
facility: Essential Dermatology
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson, MD, Dermatology, PLLC
state: Michigan
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Flint
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine
state: New Mexico
city: Brooklyn
country: United States
facility: NYU Langone Brooklyn
state: New York
city: Fairport
country: United States
facility: Universal Dermatology, PLLC
state: New York
city: Great Neck
country: United States
facility: Northwell Health, Inc. PRIME
state: New York
city: New York
country: United States
facility: Columbia University Medical center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Dermatology South Durham
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Department of Dermatology
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Hershey
country: United States
facility: Penn State University Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic, P.A.
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center, LLC
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Galveston
country: United States
facility: UTMB Department of Dermatology
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Richmond
country: United States
facility: West End Dermatology Associates
state: Virginia
city: Caba
country: Argentina
facility: CINME - Centro De Investigaciones Metabolicas
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: APRILLUS Asistencia e Investigacion
state: Ciudad Autonoma Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Respirar
state: Ciudad Autonoma Buenos Aires
city: Rosario
country: Argentina
facility: Instituto CAICI
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clinicas Tucuman
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de La Plata
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar - Mind Out Research
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Mendoza
country: Argentina
facility: Instituto de Reumatologia
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
city: Salvador
country: Brazil
facility: Clínica SER da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
state: Ceará
city: Brasilia
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas Ltda.
state: Distrito Federal
city: Vitória
country: Brazil
facility: CEDOES - Diagnóstico e Pesquisa
state: Espírito Santo
city: Santo Ângelo
country: Brazil
facility: IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
state: Mato Grosso
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa
state: Minas Gerais
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
state: Rio Do Janeiro
city: Rio de Janeiro
country: Brazil
facility: IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
state: Rio Do Janeiro
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S Ltda
state: Rio Grande Do Sul
city: Sao Bernardo Do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
state: Sao Paulo
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Ruse
country: Bulgaria
facility: DCC 1 - Ruse, EOOD
city: Sofia
country: Bulgaria
facility: DCC 'Alexandrovska', EOOD
city: Sofia
country: Bulgaria
facility: DCC Focus 5 - MEOH OOD
city: Sofia
country: Bulgaria
facility: DCC Focus 5 - MEOH OOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Calgary
country: Canada
facility: Laser Rejuvenation Clinics, Inc.
state: Alberta
city: Edmonton
country: Canada
facility: Laster Rejuvenation Clinics Edmonton D.T. Inc.
state: Alberta
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc
state: Ontario
city: Sherbrooke
country: Canada
facility: DIEX Recherche Sherbrooke Inc.
state: Quebec
city: Las Condes
country: Chile
facility: Centro Medico SkinMed
city: Santiago
country: Chile
facility: Dermacross
city: Santiago
country: Chile
facility: BioMedica Research Group
city: Santiago
country: Chile
facility: CeCim Biocinetic
city: Santiago
country: Chile
facility: CIEC - Centro Internacional de Estudios Clínicos
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA.
city: Viña del Mar
country: Chile
facility: Oncocentro APYS
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangzhou
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Chinese Academy of Medical Sciences
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun City
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University school of medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial S.A.S
state: Atlántico
city: Zipaquirá
country: Colombia
facility: Healthy Medical Center
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
state: Santander
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
city: Nice cedex 3
country: France
facility: CHU Nice - Hopital de l Archet
state: Alpes Maritimes
city: Marseille cedex 5
country: France
facility: Hôpital de la Timone
state: Bouches-du-Rhône
city: Caen
country: France
facility: CHU de Caen - Hopital de la Cote de Nacre
state: Calvados
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
state: Doubs
city: Toulouse Cedex 9
country: France
facility: Hopital Larrey
state: Haute Garonne
city: Antony
country: France
facility: Hôpital Privé d'Antony
state: Hauts De Seine
city: Montpellier Cedex 5
country: France
facility: Hopital Saint Eloi
state: Herault
city: Cedex 10
country: France
facility: Hôpital Saint-Louis
state: Paris
city: Lyon
country: France
facility: Hopital Edouard Herriot - CHU Lyon
state: Rhone
city: Paris
country: France
facility: Hopital Tenon
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Dermatologie
state: Niedersachsen
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude GmbH
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AoeR
state: Niedersachsen
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen AoeR
state: Nordrhein Westfalen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn AoeR
state: Nordrhein Westfalen
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf AoeR
state: Nordrhein Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein Westfalen
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
state: Sachsen Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Charité - Campus Charité Mitte
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Firenze
country: Italy
facility: Università degli studi di Firenze
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico 'Federico II'
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Nagoya-shi
country: Japan
facility: JCHO Chukyo Hospital
state: Aichi-Ken
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center
state: Aichi-Ken
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital
state: Aichi-Ken
city: Aomori-shi
country: Japan
facility: Aomori Prefectural Central Hospital
state: Aomori-Ken
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba-Ken
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui-Ken
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
state: Fukuoka-Ken
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kakogawa-shi
country: Japan
facility: Kakogawa Central City Hospital
state: Hyogo-Ken
city: Ono-shi
country: Japan
facility: Kita Harima Medical Center
state: Hyogo-Ken
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa-Ken
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: NHO Yokohama Medical Center
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto-Ken
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi-Ken
city: Nagasaki-Shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki-Ken
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital
state: Niigata-Ken
city: Okayama-shi
country: Japan
facility: Japanese Red Cross Okayama Hospital
state: Okayama-Ken
city: Kawachinagano-shi
country: Japan
facility: NHO Osaka Minami Medical Center
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: Daini Osaka Police Hospital
state: Osaka-Fu
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka-Fu
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka-Fu
city: Takatsuki-shi
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka-Fu
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga-Ken
city: Izumo-shi
country: Japan
facility: Shimane University Hospital
state: Shimane-Ken
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo-To
city: Shinagawa-ku
country: Japan
facility: Showa University East Hospital
state: Tokyo-To
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama-Ken
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ciudad de México
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de investigacion medica y reumatologia
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Consultorio Privado Dr. Miguel Cortes Hernandez
state: Morelos
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajio S.C.
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Lima
country: Peru
facility: Invest Clinicas Sac Inst de Ginecologia y Reproduccion
city: Mabalacat
country: Philippines
facility: The Medical City Clark
state: Pampanga
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hospital
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
city: Manila
country: Philippines
facility: Medical Center Manila
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Manila
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
city: Quezon City, Metro Manila
country: Philippines
facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: San Fenando, La Union
country: Philippines
facility: Ilocos Training and Regional Medical Center
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski
city: Kraków
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus
city: Warszawa
country: Poland
facility: Royalderm
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
city: Lisboa
country: Portugal
facility: Hospital de Egas Moniz
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Porto
country: Portugal
facility: Centro Hospitalar Universitártio do Porto, E.P.E.
city: Viana do Castelo
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, E.P.E.
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC - Hato Rey
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Riyadh
country: Saudi Arabia
facility: King Saud University
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Kosice
country: Slovakia
facility: Artromac n.o.
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
state: Cantabria
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset - Solna
city: Zurich-Flughafen
country: Switzerland
facility: Universitaetsspital Zuerich
state: Zurich
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Changhua
country: Taiwan
facility: Changhua Christian Medical Foundation Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Greater London
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: Greater Manchester
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
state: West Midlands
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
state: West Yorkshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: