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
TOPAZ-2
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
2 other identifiers
interventional
562
17 countries
177
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), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
Longer than P75 for phase_3
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 16, 2027
January 29, 2026
January 1, 2026
5.2 years
July 5, 2021
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
An SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). * No new organ system affected as defined by no new organ system with British Isles Lupus Assessment Group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline. * No worsening from baseline in lupus disease activity as defined by \<0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS). * No violation to protocol-specified medication rules.
Week 52
Secondary Outcomes (33)
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG) - Based Combined Lupus Assessment (BICLA) Response at Week 52
Week 52
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
Week 52
Percentage of Participants With Oral Corticosteroid(s) (OCS) ≥10 milligrams per day (mg/day) at Baseline With 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
Week 40 up to Week 52
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 24
Week 24
Annualized Flare Rate Through Week 52
Up to Week 52
- +28 more secondary outcomes
Study Arms (3)
Litifilimab High Dose
EXPERIMENTALParticipants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Litifilimab Low Dose
EXPERIMENTALParticipants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.
Placebo
PLACEBO COMPARATORParticipants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Interventions
Administered as specified in the treatment arm.
Eligibility Criteria
You may qualify if:
- Participant must be diagnosed with 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-200 (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.
- Participants 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:
- Antimalarials as stand-alone treatment
- Antimalarial treatment in combination with OCS and/or a single immunosuppressant
- Treatment with OCS and/or a single immunosuppressant.
You may not qualify if:
- 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 antibody to hepatitis 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, such as adding intravenous (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (177)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306, United States
Care Access Research - Huntington BeachCare Access Research - Huntington Beach
Huntington Beach, California, 92648, United States
Valerius Medical Group
Los Alamitos, California, 90720, United States
The Practice of Medicine
Los Angeles, California, 90004, United States
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
Monterey Park, California, 91754, United States
Neurovations
Napa, California, 94558, United States
Joo-Hyung Lee MD
Orange, California, 92868, United States
Medvin Clinical Research
Whittier, California, 90602, United States
RASF - Clinical Research Center
Boca Raton, Florida, 33486, United States
University of Florida
Gainesville, Florida, 32611, United States
Vida Clinical Research
Kissimmee, Florida, 34741, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
HMD Research, LLC
Orlando, Florida, 32819, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606, United States
The Emory Clinic Emory University
Atlanta, Georgia, 30322, United States
Jefrey Lieberman, M.D., P.C.
Decatur, Georgia, 30033, United States
Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
Gainesville, Georgia, 30501, United States
RNA America Health Sciences
Gainesville, Georgia, 30518, United States
EBGS Clinical Trials
Snellville, Georgia, 30078, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
DM Clinical Research - Boston
Brookline, Massachusetts, 02445, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Saint Louis Rheumatology
St Louis, Missouri, 63119, United States
Arthritis & Osteoporosis Associates, PA
Freehold, New Jersey, 07728, United States
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, 88011, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
University of Cincinnati
Cincinnati, Ohio, 45206-0829, United States
STAT Research
Dayton, Ohio, 45417, United States
Piedmont Arthritis Clinic, P.A.
Greenville, South Carolina, 29601, United States
Low Country Rheumatology, PA
Summerville, South Carolina, 29486, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Arthritis & Rheumatology Institute
Allen, Texas, 75013, United States
Office of John P. Lavery M.D., PA
Allen, Texas, 75013, United States
Tekton Research
Austin, Texas, 78745, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
R and H Clinical Research
Katy, Texas, 77494, United States
Prime Clinical Research
Mansfield, Texas, 76063, United States
SouthWest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Sun Research Institute, LLC
San Antonio, Texas, 78215, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Instituto de Investigaciones Clinicas Quilmes
Buenos Aires, Buenos Aires, B1878GEG, Argentina
Hospital Italiano de La Plata
Buenos Aires, Buenos Aires, B1900AXI, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, Buenos Aires, C1221ADC, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK, Argentina
Policlìnica Red Omip S.A - Ensayos Clinicos GC
Mar del Plata, Buenos Aires, B7600GNY, Argentina
Centro Dermatologico Schejtman
San Miguel, Buenos Aires, B1663, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA, Argentina
Instituto CAICI
Rosario, Santa Fe Province, S2000PBJ, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina
Centro Medico Barrio Parque
Buenos Aires, C1425, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, 1425, Argentina
STAT Research S.A.
Ciudad Autonoma Buenos Aires, C1013AAB, Argentina
Organizacion Medica de Investigacion (OMI)
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1280AEB, Argentina
Centro Privado de Medicina Familiar - Mind Out Research
Ciudad Autonoma Buenos Aires, C1417, Argentina
Sanatorio Allende
Córdoba, X5000JHQ, Argentina
Instituto de Reumatologia
Mendoza, M5500, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, 5400, Argentina
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
The Waterside Clinic
Barrie, Ontario, L4M 6L2, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8V 1C3, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Dongguan People's Hospital
Dongguan, Guangdong, 523059, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The second Xiangya Hospital of Central South University
Changsha, Hu'nan, 410011, China
ZhuZhou Central Hospital
Zhuzhou, Hu'nan, 412000, China
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Jilin Province People's Hospital
Changchun, Jilin, 130021, China
Yanbian University Hospital (Yanbian Hospital)
Yanji, Jilin, 133000, China
Jiujiang No.1 People's Hospital
Jiujiang, Jiujiang, 332000, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, Shanghai Municipality, 200001, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610500, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
The First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital, Central South University
Changsha, 410008, China
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, 080020, Colombia
Clínica de la Costa Ltda.
Barranquilla, 080020, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
Bogotá, 110221, Colombia
Servimed S.A.S.
Bucaramanga, 680003, Colombia
IPS Centro Medico Julián Coronel S.A.
Cali, 760001, Colombia
Preventive Care Ltda
Chía, 250001, Colombia
Healthy Medical Center
Zipaquirá, 250252, Colombia
Revmatologie s.r.o.
Brno, 638 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77520, Czechia
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, 37075, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Bekes Varmegyei Kozponti Korhaz
Gyula, 5700, Hungary
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Székesfehérvár, 8000, Hungary
Vital Medical Center
Veszprém, 8200, Hungary
Rambam Health Care Center
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 49372, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Ospedale M. Scarlato
Scafati, Salerno, 84018, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
Azienda Ospedale-Università di Padova
Padua, 35100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00151, Italy
Università Campus Bio-Medico di Roma
Roma, 00155, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 00161, Italy
JCHO Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
NHO Chibahigashi National Hospital
Chiba, Chiba, 260-8712, Japan
Chibaken Saiseikai Narashino Hospital
Narashino-shi, Chiba, 275-8580, Japan
KKR Hamanomachi Hospital
Fukuoka, Fukuoka, 810-8539, Japan
NHO Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Tonan Hospital
Sapporo, Hokkaido, 060-0004, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, 670-8540, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
NHO Yokohama Medical Center
Yokohama, Kanagawa, 245-8575, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
NHO Osaka Minami Medical Center
Kawachinagano-shi, Osaka, 586-8521, Japan
Tazuke-kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, 569-8686, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495, Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, Tokyo-To, 113-8519, Japan
St. Luke's International Hospital
Chūōku, Tokyo-To, 104-8560, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To, 173-8610, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo-To, 153-8515, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo-To, 143-8541, Japan
Keio University Hospital
Shinjuku-ku, Tokyo-To, 160-8582, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo-To, 162-8655, Japan
Amsterdam UMC, Locatie VUMC
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Centro Reumatologico
Caguas, 00725, Puerto Rico
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
Brasov, 500283, Romania
S C Delta Health Care SRL
Bucharest, 014142, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006, Romania
S.C.Centrul Medical Unirea SRL
Iași, 700023, Romania
Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava
Suceava, 720284, Romania
S.C Centrul Medical Unirea SRL
Târgu Mureş, 540136, Romania
Institute of Rheumatology
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska kosa
Belgrade, 11080, Serbia
Institute of Treatment and Rehabilitation 'Niska Banja'
Niška Banja, 18205, Serbia
Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Guy's Hospital
London, Greater London, SE1 9RT, United Kingdom
Doncaster Royal Infirmary
Doncaster, South Yorkshire, DN2 5LT, United Kingdom
Cannock Chase Hospital
Cannock, Staffordshire, WS11 5XY, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2021
First Posted
July 14, 2021
Study Start
July 16, 2021
Primary Completion (Estimated)
September 27, 2026
Study Completion (Estimated)
March 16, 2027
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/