Phase
Condition
Memory Loss
Multiple Sclerosis
Neurologic Disorders
Treatment
Placebo
DRF
BIIB091
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
Connect with a study center
'MHAT Avis - Medica' OOD
Pleven, 5800
BulgariaActive - Recruiting
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800
BulgariaActive - Recruiting
UMHAT 'Sv. Georgi', EAD
Plovdiv, 4002
BulgariaActive - Recruiting
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
BulgariaActive - Recruiting
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
BulgariaActive - Recruiting
University First MHAT-Sofia, 'St. Joan Krastitel' EAD
Sofia, 1142
BulgariaActive - Recruiting
Ospedale Regionale di Lugano
Lugano, Ticino 6903
CzechiaActive - Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691
CzechiaActive - Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 50005
CzechiaActive - Recruiting
Nemocnice Jihlava p.o.
Jihlava, 58633
CzechiaActive - Recruiting
Fakultni Thomayerova nemocnice
Praha 4-Krc, 14059
CzechiaActive - Recruiting
Krajska zdravotni a.s. - Nemocnice Teplice o.z.
Teplice, 41529
CzechiaActive - Recruiting
Studienzentrum fur Neurologie und Psychiatrie
Boeblingen, Baden Wuerttemberg 71034
GermanyActive - Recruiting
Klinikum Bayreuth GmbH- Hohe Warte
Bayreuth, Bayern 95445
GermanyActive - Recruiting
Neuropraxis Muenchen Sued
Unterhaching, Bayern 82008
GermanyActive - Recruiting
Universitaetsklinikum Duesseldorf AoeR
Duesseldorf, Nordrhein Westfalen 40225
GermanyActive - Recruiting
ZNS - Zentrum fuer Neurologisch-Psychiatrische Studien
Siegen, Nordrhein Westfalen 57076
GermanyActive - Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
GermanyActive - Recruiting
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli, Isernia 86077
ItalyActive - Recruiting
Fondazione Istituto G.Giglio di Cefalù
Cefalù, Palermo 90015
ItalyActive - Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, 80138
ItalyActive - Recruiting
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, 00133
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 00161
ItalyActive - Recruiting
COPERNICUS Podmiot Leczniczy Sp. z o. o.,
Gdansk, 80-803
PolandActive - Recruiting
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki, 05-825
PolandActive - Recruiting
Centrum Medyczne Pratia Katowice
Katowice, 40-081
PolandActive - Recruiting
M.A. - LEK A.M.Maciejowscy SC.
Katowice, 40-571
PolandActive - Recruiting
Nzoz Novo-Med
Katowice, 40-650
PolandActive - Recruiting
Resmedica Sp.z o.o
Kielce, 25-726
PolandActive - Recruiting
MCD Medical
Krakow, 31-637
PolandActive - Recruiting
Szpital Uniwersytecki w Krakowie
Krakow, 31-503
PolandActive - Recruiting
Centrum Neurologii K. Selmaj
Lodz, 90-324
PolandActive - Recruiting
Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
Oswiecim, 32-600
PolandActive - Recruiting
Med-Polonia Sp. z o.o.
Poznan, 60-693
PolandActive - Recruiting
NZOZ 'NEURO-KARD', 'Ilkowski i Partnerzy' Sp. Partn. Lek.
Poznan, 61-853
PolandActive - Recruiting
Nzoz Palomed
Rzeszów, 35-323
PolandActive - Recruiting
NeuroProtect Sp. z o.o.
Warszawa, 01-684
PolandActive - Recruiting
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze, 41-800
PolandActive - Recruiting
Caribbean Center for Clinical Research
Guaynabo, 00968
Puerto RicoActive - Recruiting
Spitalul Universitar de Urgenta Elias
Bucuresti, 11461
RomaniaActive - Recruiting
S.C Neurocity S.R.L
București, 11302
RomaniaActive - Recruiting
S.C Clubul Sanatatii SRL
Campulung Muscel, 115100
RomaniaActive - Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainActive - Recruiting
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia 30120
SpainActive - Recruiting
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Universitario Reina Sofia
Cordoba, 14011
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Regional Universitario de Malaga
Malaga, 29010
SpainActive - Recruiting
Ospedale Regionale di Lugano
Lugano, Ticino 6903
SwitzerlandActive - Recruiting
Inselspital - Universitaetsspital Bern
Bern, 3010
SwitzerlandActive - Recruiting
Universitaetsspital Zuerich
Zuerich, 8091
SwitzerlandActive - Recruiting
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Alta Bates Summit Medical Center
Berkeley, California 94705
United StatesActive - Recruiting
University of California at Irvine Medical Center
Orange, California 92868
United StatesActive - Recruiting
University of Colorado School of Medic
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
Vero Beach Neurology and Research Institute
Vero Beach, Florida 32960
United StatesActive - Recruiting
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Fort Wayne Neurology
Fort Wayne, Indiana 46845
United StatesActive - Recruiting
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
United StatesActive - Recruiting
International Neurorehabilitation Institute
Lutherville, Maryland 21093
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Holy Name
Teaneck, New Jersey 07666
United StatesActive - Recruiting
University of New Mexico
Albuquerque, New Mexico 87131-0001
United StatesActive - Recruiting
South Shore Neurologic Associates, P.C.
Patchogue, New York 11772
United StatesActive - Recruiting
Wake Forest University - School of Medicine - Central
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
University of Cincinnati Physicians Company
Cincinnati, Ohio 45267
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
The Boster Center for MS
Columbus, Ohio 43235
United StatesActive - Recruiting
The Boster Center for Multiple Sclerosis
Columbus, Ohio 43235
United StatesActive - Recruiting
Neurology Clinic, PC
Cordova, Tennessee 38018
United StatesActive - Recruiting
Vanderbilt MS Center
Nashville, Tennessee 37215
United StatesActive - Recruiting
The University of Texas Health Science Center San Antonio
San Antonio, Texas 78229-3900
United StatesActive - Recruiting
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
United StatesActive - Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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