Clinical trial NCT04895241: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus
SLE
CLE
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 540
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 systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:

- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).

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 SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.


Eligibility criteria: Key Inclusion Criteria:

* Participant must be diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at screening by a qualified physician.
* Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥ 6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
* Participant has a modified clinical SLEDAI-2K score ≥ 4 (excluding anti-dsDNA, low complement component 3 (C3) and/or complement component 4 (C4), alopecia, fever, lupus-related headache, and organic brain syndrome) at Screening (adjudicated) and randomization.
* Participant has BILAG-2004 grade A in ≥ 1 organ system or BILAG-2004 grade B in ≥ 2 organ systems at Screening (adjudicated) and randomization.
* Participant must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥ 12 weeks prior to Screening and at stable dose ≥ 4 weeks prior to randomization:

  1. Antimalarials as stand-alone treatment
  2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant
  3. Treatment with OCS and/or a single immunosuppressant

Key Exclusion Criteria:

* History of or positive test result for human immunodeficiency virus (HIV).
* Current hepatitis C infection (defined as positive hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid \[RNA\]).
* Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen (HBsAg) and/or positive for total hepatitis antibody to B core antigen \[anti-HBc\] with positive reflex HBV DNA).
* History of severe herpes infection.
* Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure.
* Active severe lupus nephritis where, in the opinion of the Investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach is indicated, such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol is indicated; or urine protein-creatinine ratio \> 2.0 or severe chronic kidney disease (estimated glomerular filtration rate \< 30 milliliters per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) calculated using the abbreviated modification of diet in renal disease equation.
* Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
* History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
* Active neuropsychiatric SLE.
* Use of oral prednisone (or equivalent) above 20 mg/day.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved an SRI-4 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants with OCS ≥10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52
timeFrame: Week 40 to Week 52
measure: Percentage of Participants with a CLASI-A score ≥10 at Baseline Who Achieved a 50% Improvement From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16
timeFrame: Week 16
measure: Annualized Flare Rate Through Week 52
timeFrame: Up to Week 52
measure: Change from Baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
timeFrame: Up to Week 52
measure: Time to Onset of SRI-4 Response Sustained Through Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants with Joint-50 Response by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤ 1 by Visit
timeFrame: Up to Week 52
measure: Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
timeFrame: Up to Week 52
measure: Time to First Severe Flare as defined by the Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI)
timeFrame: Up to Week 52
measure: Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
timeFrame: Up to Week 52
measure: Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With ≥ 3, ≥ 5, and ≥ 7 Consecutive Visits in LLDAS up to and Including Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants who Achieved LLDAS at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
timeFrame: Week 52
measure: Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
timeFrame: Up to Week 52
measure: Change From Baseline in Short Form Health Survey-36 (SF-36) Score
timeFrame: Up to Week 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
timeFrame: Up to Week 52
measure: Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Up to Week 52
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
timeFrame: Up to Week 52
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 52
measure: Number of Participants with Antibodies to Litifilimab
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Tilda Research Birmingham
state: Alabama
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Mission Hills
country: United States
facility: Providence Facey Medical Foundation
state: California
city: Mission Hills
country: United States
facility: Providence Facey Medical Foundation
state: California
city: San Diego
country: United States
facility: University of California San Diego School of Medicine
state: California
city: Thousand Oaks
country: United States
facility: SCLA Management
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital-Medstar
state: District of Columbia
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
city: Avon Park
country: United States
facility: Highlands Rheumatology
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Corporate
state: Florida
city: Coral Springs
country: United States
facility: Believe Clinical Trials
state: Florida
city: Coral Springs
country: United States
facility: Believe Clinical Trials
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Hollywood
country: United States
facility: GNP Research at Mark Jaffe, MD
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials
state: Florida
city: Miami Lakes
country: United States
facility: Charisma Medical and Research Center
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
city: Tampa
country: United States
facility: AdventHealth Medical Group
state: Florida
city: Tampa
country: United States
facility: Vantage Clinical Trials
state: Florida
city: Kennesaw
country: United States
facility: Rheumatology care of Georgia
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology LLC
state: Georgia
city: Lake Charles
country: United States
facility: Accurate Clinical Research Inc.
state: Louisiana
city: Flint
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Reno
country: United States
facility: Renown Medical Group
state: Nevada
city: Brooklyn
country: United States
facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health Center for Advanced Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Salisbury
country: United States
facility: OnSite Clinical Solutions, LLC - Charlotte
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Memphis
country: United States
facility: Ramesh C Gupta, MD
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Allen
country: United States
facility: PrimeCare 360
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solution
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solution
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Corpus Christi
country: United States
facility: Arthritis Care Texas
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management LLC
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Humble
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Stafford
country: United States
facility: Accurate Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Fort Bend Rheumatology Associates
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Webster
country: United States
facility: CLS Research Ctr, PLLC
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
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: Cuiabá
country: Brazil
facility: Oncovida - Centro de Onco-Hematologia de Mato Grosso
state: Mato Grosso
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa
state: Minas Gerais
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras Ltda.
state: Paraná
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
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: LMK Serviços Médicos S/S Ltda
state: Rio Grande Do Sul
city: Sao Jose Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: Sao Paulo
city: São Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
state: Sao Paulo
city: Valinhos
country: Brazil
facility: A2Z Clinical Centro Avancado de Pesquisa Clinica
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: RDSS Ricardo Diaz Scientific Solution
city: Plovdiv
country: Bulgaria
facility: DCC 'Sv. Georgi', EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Pulmed" OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT-Plovdiv AD
city: Ruse
country: Bulgaria
facility: DCC 1 - Ruse, EOOD
city: Sofia
country: Bulgaria
facility: DCC 'Alexandrovska', EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: UMHAT 'Sv. Ivan Rilski', EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Sv. Ivan Rilski', EAD
city: Osorno
country: Chile
facility: Clinica Alemana de Osorno
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: Interin
city: Santiago
country: Chile
facility: CTR Estudios
city: Santiago
country: Chile
facility: Enroll Spa
city: Santiago
country: Chile
facility: BioMedica Research Group
city: Santiago
country: Chile
facility: CeCim Biocinetic
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA.
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin
state: Gironde
city: Montpellier Cedex 5
country: France
facility: Hopital Lapeyronie
state: Herault
city: Clermont-Ferrand cedex 1
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
state: Puy De Dome
city: Athens
country: Greece
facility: NNA Hospita;
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Athens
country: Greece
facility: University General Hospital 'Attikon'
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Ciudad de México
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Farmaceutica Especializada de Occidente S.C
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
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: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
state: Nuevo León
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo León
city: Merida
country: Mexico
facility: Centro Peninsular de Investigacion Clinica, SCP
state: Yucatán
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud S.C.
state: Yucatán
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Durango
country: Mexico
facility: Centro de Investigacion y Atencion Integral Durango CIAID
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Arequipa
country: Peru
facility: Hogar Clínica San Juan de Dios - Arequipa
city: Lima
country: Peru
facility: Centro de Investigacion Clinica Immunoreumatologioa
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: HMA - Hospital Maria Auxiliadora
city: Lima
country: Peru
facility: Invest Clinicas Sac Inst de Ginecologia y Reproduccion
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo
country: Philippines
facility: The Medical City Iloilo
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
city: Mabalacat, Pampanga
country: Philippines
facility: The Medical City Clark
city: Manila
country: Philippines
facility: Manila Doctors Hospital
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: Quenzon City
country: Philippines
facility: St. Luke's Medical Center
city: Quezon City, Metro Manila
country: Philippines
facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation
city: San Fernando City, La Union
country: Philippines
facility: Lorma Medical Center
city: Taguig
country: Philippines
facility: Ospital Ng Makati
city: Bialystok
country: Poland
facility: Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Intercor Sp. z o.o
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Bytom
country: Poland
facility: Nzoz Bif-Med
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Krakow
country: Poland
facility: Centrum Medyczne All-Med
city: Lublin
country: Poland
facility: Reumed Spolka z o.o.
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia NCM
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska prof Pawel Hrycaj
city: Warszawa
country: Poland
facility: Przychodnia Care Access Warszawa
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Wroclaw
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Uppasala
country: Sweden
facility: Akademiska Sjukhuset
city: Örebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital,Linkou
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: