Phase
Condition
Neurologic Disorders
Multiple Sclerosis
Memory Loss
Treatment
BIIB091
Placebo
DRF
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Diagnosis of RMS [relapsing-remitting multiple sclerosis (RRMS) or active secondaryprogressive multiple sclerosis (SPMS)] in accordance with the 2017 Revised McDonaldcriteria.
Time since MS symptom onset is <20 years.
Must have expanded disability status scale (EDSS) score of 0 through 5.0 atscreening and baseline.
Must have at least 1 of the following occurring prior to Baseline (Day 1):
≥2 clinical relapses in the last 24 months (but not within 30 days prior toBaseline [Day 1]) with at least 1 relapse during the last 12 months prior torandomization.
≥1 clinical relapse within the past 24 months (but not within 30 days prior toBaseline [Day 1]) and ≥1 new brain MRI lesion (Gd-positive and/or new orenlarging T2 hyperintense lesion) within the past 12 months prior torandomization. The screening MRI could be used to satisfy this criterion (ifneeded for inclusion, local reading is required). For new or enlarging T2hyperintense lesions, the reference scan cannot be >12 months prior torandomization.
≥1 GdE lesion on brain MRI within 6 months prior to randomization.
Exclusion
Key Exclusion Criteria:
Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria.
An MS relapse that has occurred within 30 days prior to Baseline (Day 1) or theparticipant has not stabilized from a previous relapse at the time of screening.
History of severe allergic, anaphylactic reactions or hypersensitivity reaction toBIIB091 or DRF, the excipients contained in the formulation, and if appropriate, anydiagnostic agents to be administered during the study, including the following:
Known hypersensitivity to any components of the study treatment
Known hypersensitivity to previous fumarate or bruton's tyrosine kinase (BTK)inhibitor treatments
History of hypersensitivity to parenteral administration of Gd-based contrastagents
Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionwithin the past 4 weeks prior to Baseline.
History of human immunodeficiency virus (HIV) infection or a positive orindeterminate test result at screening for HIV.
Current or history of hepatitis C infection regardless of viral load.
Current or history of hepatitis B infection.
Current enrollment or plan to enroll in any other drug, biological, device, clinicalstudy, or treatment with an investigational drug or approved therapy forinvestigational use within 90 days prior to randomization or 5 half-lives of thedrug or therapy, whichever is longer.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
'MHAT Avis - Medica' OOD
Pleven, 5800
BulgariaSite Not Available
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800
BulgariaActive - Recruiting
'MHAT Avis - Medica' OOD
Pleven 728203, 5800
BulgariaSite Not Available
UMHAT 'Dr. Georgi Stranski', EAD
Pleven 728203, 5800
BulgariaSite Not Available
UMHAT 'Sv. Georgi', EAD
Plovdiv, 4002
BulgariaSite Not Available
UMHAT 'Sv. Georgi', EAD
Plovdiv 728193, 4002
BulgariaSite Not Available
Acibadem City Clinic Tokuda University Hospital Ead
Sofia, 1407
BulgariaActive - Recruiting
DCC Neoclinic EAD
Sofia, 1408
BulgariaActive - Recruiting
Diagnostic Consultation Center CONVEX EOOD
Sofia, 1680
BulgariaActive - Recruiting
MHATNP 'Sv.Naum', EAD
Sofia, 1113
BulgariaSite Not Available
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
BulgariaActive - Recruiting
University First MHAT-Sofia, 'St. Joan Krastitel' EAD
Sofia, 1142
BulgariaActive - Recruiting
Acibadem City Clinic Tokuda University Hospital Ead
Sofia 727011, 1407
BulgariaSite Not Available
DCC Neoclinic EAD
Sofia 727011, 1408
BulgariaSite Not Available
Diagnostic Consultation Center CONVEX EOOD
Sofia 727011, 1680
BulgariaSite Not Available
MHATNP 'Sv.Naum', EAD
Sofia 727011, 1113
BulgariaSite Not Available
UMHAT "Sv. Ivan Rilski", EAD
Sofia 727011, 1431
BulgariaSite Not Available
University First MHAT-Sofia, 'St. Joan Krastitel' EAD
Sofia 727011, 1142
BulgariaSite Not Available
Ospedale Regionale di Lugano
Lugano, Ticino 6903
CzechiaActive - Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691
CzechiaSite Not Available
Fakultni nemocnice u sv. Anny v Brne
Brno 3078610, 65691
CzechiaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 50005
CzechiaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Králové 3074967, 50005
CzechiaSite Not Available
Nemocnice Jihlava p.o.
Jihlava, 58633
CzechiaSite Not Available
Nemocnice Jihlava p.o.
Jihlava 3074199, 58633
CzechiaSite Not Available
Fakultni Thomayerova nemocnice
Praha 4-Krc, 14059
CzechiaSite Not Available
Krajska zdravotni a.s. - Nemocnice Teplice o.z.
Teplice, 41529
CzechiaSite Not Available
Krajska zdravotni a.s. - Nemocnice Teplice o.z.
Teplice 3064288, 41529
CzechiaSite Not Available
Studienzentrum fur Neurologie und Psychiatrie
Boeblingen, Baden Wuerttemberg 71034
GermanySite Not Available
Studienzentrum fur Neurologie und Psychiatrie
Böblingen 2947444, Baden-Wurttemberg 2953481 71034
GermanySite Not Available
Klinikum Bayreuth GmbH- Hohe Warte
Bayreuth 2951825, Bavaria 2951839 95445
GermanySite Not Available
Neuropraxis Muenchen Sued
Unterhaching 2819465, Bavaria 2951839 82008
GermanySite Not Available
Klinikum Bayreuth GmbH- Hohe Warte
Bayreuth, Bayern 95445
GermanySite Not Available
Neuropraxis Muenchen Sued
Unterhaching, Bayern 82008
GermanySite Not Available
Universitaetsklinikum Duesseldorf AoeR
Duesseldorf, Nordrhein Westfalen 40225
GermanySite Not Available
ZNS - Zentrum fuer Neurologisch-Psychiatrische Studien
Siegen, Nordrhein Westfalen 57076
GermanySite Not Available
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf 2934246, North Rhine-Westphalia 2861876 40225
GermanySite Not Available
ZNS - Zentrum fuer Neurologisch-Psychiatrische Studien
Siegen 2832495, North Rhine-Westphalia 2861876 57076
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden 2935022, 01307
GermanySite Not Available
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli, Isernia 86077
ItalySite Not Available
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli 3170006, Isernia 86077
ItalySite Not Available
Fondazione Istituto G.Giglio di Cefalù
Cefalù, Palermo 90015
ItalySite Not Available
Fondazione Istituto G.Giglio di Cefalù
Cefalù 2525041, Palermo 90015
ItalySite Not Available
IRCCS Ospedale Policlinico San Martino
Genova, 16132
ItalySite Not Available
IRCCS Ospedale Policlinico San Martino
Genova 8969657, 16132
ItalySite Not Available
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, 80138
ItalySite Not Available
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli 9031661, 80138
ItalySite Not Available
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
ItalySite Not Available
Fondazione Istituto Neurologico Casimiro Mondino
Pavia 3171366, 27100
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, 00133
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 00161
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma 8957247, 00133
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma 8957247, 00161
ItalySite Not Available
COPERNICUS Podmiot Leczniczy Sp. z o. o.,
Gdansk, 80-803
PolandSite Not Available
COPERNICUS Podmiot Leczniczy Sp. z o. o.,
Gdansk 3099434, 80-803
PolandSite Not Available
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki, 05-825
PolandSite Not Available
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki 771401, 05-825
PolandSite Not Available
Centrum Medyczne Pratia Katowice
Katowice, 40-081
PolandSite Not Available
M.A. - LEK A.M.Maciejowscy SC.
Katowice, 40-571
PolandActive - Recruiting
Nzoz Novo-Med
Katowice, 40-650
PolandActive - Recruiting
Centrum Medyczne Pratia Katowice
Katowice 3096472, 40-081
PolandSite Not Available
M.A. - LEK A.M.Maciejowscy SC.
Katowice 3096472, 40-571
PolandSite Not Available
Nzoz Novo-Med
Katowice 3096472, 40-650
PolandSite Not Available
Resmedica Sp.z o.o
Kielce, 25-726
PolandSite Not Available
Resmedica Sp.z o.o
Kielce 769250, 25-726
PolandSite Not Available
MCD Medical
Krakow, 31-637
PolandActive - Recruiting
Szpital Uniwersytecki w Krakowie
Krakow, 31-503
PolandSite Not Available
Szpital Uniwersytecki w Krakowie
Krakow 3094802, 31-503
PolandSite Not Available
Centrum Neurologii K. Selmaj
Lodz, 90-324
PolandSite Not Available
Centrum Neurologii K. Selmaj
Lodz 3093133, 90-324
PolandSite Not Available
Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
Oswiecim, 32-600
PolandSite Not Available
Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
Oświęcim 3089658, 32-600
PolandSite Not Available
Med-Polonia Sp. z o.o.
Poznan, 60-693
PolandActive - Recruiting
NZOZ 'NEURO-KARD', 'Ilkowski i Partnerzy' Sp. Partn. Lek.
Poznan, 61-853
PolandSite Not Available
Med-Polonia Sp. z o.o.
Poznan 3088171, 60-693
PolandSite Not Available
NZOZ 'NEURO-KARD', 'Ilkowski i Partnerzy' Sp. Partn. Lek.
Poznan 3088171, 61-853
PolandSite Not Available
Nzoz Palomed
Rzeszów, 35-323
PolandSite Not Available
Nzoz Palomed
Rzeszów 759734, 35-323
PolandSite Not Available
NeuroProtect Sp. z o.o.
Warsaw 756135, 01-684
PolandSite Not Available
NeuroProtect Sp. z o.o.
Warszawa, 01-684
PolandSite Not Available
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze, 41-800
PolandSite Not Available
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze 3080985, 41-800
PolandSite Not Available
Caribbean Center for Clinical Research
Guaynabo, San Juan 4568138 00968
Puerto RicoSite Not Available
S.C Neurocity S.R.L
Bucharest 683506, 11302
RomaniaSite Not Available
Spitalul Universitar de Urgenta Elias
Bucharest 683506, 11461
RomaniaSite Not Available
Spitalul Universitar de Urgenta Elias
Bucuresti, 11461
RomaniaSite Not Available
S.C Neurocity S.R.L
București, 11302
RomaniaSite Not Available
S.C Clubul Sanatatii SRL
Campulung Muscel, 115100
RomaniaSite Not Available
S.C Clubul Sanatatii SRL
Campulung Muscel 681850, 115100
RomaniaSite Not Available
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón 3112989, Madrid 3117732 28223
SpainSite Not Available
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia 30120
SpainSite Not Available
Hospital Universitario Virgen de la Arrixaca
El Palmar 2518294, Murcia 2513413 30120
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital del Mar
Barcelona 3128760, 08003
SpainSite Not Available
Hospital Universitario Reina Sofia
Cordoba, 14011
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba 2519240, 14011
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid 3117735, 28034
SpainSite Not Available
Hospital Regional Universitario de Malaga
Malaga, 29010
SpainSite Not Available
Hospital Regional Universitario de Malaga
Málaga 2514256, 29010
SpainSite Not Available
Ospedale Regionale di Lugano
Lugano 2659836, Canton Ticino 2658370 6903
SwitzerlandSite Not Available
Ospedale Regionale di Lugano
Lugano, Ticino 6903
SwitzerlandSite Not Available
Inselspital - Universitaetsspital Bern
Bern, 3010
SwitzerlandSite Not Available
Inselspital - Universitaetsspital Bern
Bern 2661552, 3010
SwitzerlandSite Not Available
Universitaetsspital Zuerich
Zuerich, 8091
SwitzerlandSite Not Available
Universitaetsspital Zuerich
Zurich 2657896, 8091
SwitzerlandSite Not Available
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesSite Not Available
HonorHealth Neurology
Scottsdale 5313457, Arizona 5551752 85251
United StatesSite Not Available
Alta Bates Summit Medical Center
Berkeley, California 94705
United StatesSite Not Available
University of California at Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
Alta Bates Summit Medical Center
Berkeley 5327684, California 5332921 94705
United StatesSite Not Available
University of California at Irvine Medical Center
Orange 5379513, California 5332921 92868
United StatesSite Not Available
University of Colorado School of Medic
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado School of Medic
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Vero Beach Neurology and Research Institute
Vero Beach, Florida 32960
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Vero Beach Neurology and Research Institute
Vero Beach 4176409, Florida 4155751 32960
United StatesSite Not Available
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
United StatesSite Not Available
Fort Wayne Neurology
Fort Wayne, Indiana 46845
United StatesActive - Recruiting
Fort Wayne Neurological Center
Fort Wayne 4920423, Indiana 4921868 46804
United StatesSite Not Available
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center Research Institute, Inc.
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
International Neurorehabilitation Institute
Lutherville, Maryland 21093
United StatesSite Not Available
International Neurorehabilitation Institute
Lutherville 4361379, Maryland 4361885 21093
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Holy Name
Teaneck, New Jersey 07666
United StatesSite Not Available
Holy Name
Teaneck 5105262, New Jersey 5101760 07666
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87131-0001
United StatesSite Not Available
University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87131-0001
United StatesSite Not Available
South Shore Neurologic Associates, P.C.
Patchogue, New York 11772
United StatesSite Not Available
South Shore Neurologic Associates, P.C.
Patchogue 5130672, New York 5128638 11772
United StatesSite Not Available
Wake Forest University - School of Medicine - Central
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest University - School of Medicine - Central
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
University of Cincinnati Physicians Company
Cincinnati, Ohio 45267
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
The Boster Center for MS
Columbus, Ohio 43235
United StatesActive - Recruiting
The Boster Center for Multiple Sclerosis
Columbus, Ohio 43235
United StatesSite Not Available
University of Cincinnati Physicians Company
Cincinnati 4508722, Ohio 5165418 45267
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
The Boster Center for Multiple Sclerosis
Columbus 4509177, Ohio 5165418 43235
United StatesSite Not Available
Neurology Clinic, PC
Cordova, Tennessee 38018
United StatesSite Not Available
Vanderbilt MS Center
Nashville, Tennessee 37215
United StatesSite Not Available
Neurology Clinic, PC
Cordova 4050552, Tennessee 4662168 38018
United StatesSite Not Available
Vanderbilt MS Center
Nashville 4644585, Tennessee 4662168 37215
United StatesSite Not Available
The University of Texas Health Science Center San Antonio
San Antonio, Texas 78229-3900
United StatesSite Not Available
The University of Texas Health Science Center San Antonio
San Antonio 4726206, Texas 4736286 78229-3900
United StatesSite Not Available
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
United StatesSite Not Available
The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
University of Wisconsin Hospital and Clinics
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available
The Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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