A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis (FUSION)

April 16, 2024 updated by: Biogen

A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis

The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

275

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • UMHAT 'Dr. Georgi Stranski', EAD
        • Contact:
          • Phone Number: 359887381827
        • Principal Investigator:
          • Maya Danovska-Mladenova
      • Pleven, Bulgaria, 5800
        • Recruiting
        • 'MHAT Avis - Medica' OOD
        • Contact:
          • Phone Number: 359889361500
        • Principal Investigator:
          • Hristo Lilovski
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • UMHAT 'Sv. Georgi', EAD
        • Contact:
          • Phone Number: 359885247929
        • Principal Investigator:
          • Georgi Slavov
      • Sofia, Bulgaria, 1431
        • Recruiting
        • UMHAT "Sv. Ivan Rilski", EAD
        • Contact:
          • Phone Number: 35928526940
        • Principal Investigator:
          • Penko Minkov Shotekov
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Diagnostic Consultation Center CONVEX EOOD
        • Contact:
          • Phone Number: 35929225914
        • Principal Investigator:
          • Krasimir Genov
      • Sofia, Bulgaria, 1142
        • Recruiting
        • University First MHAT-Sofia, 'St. Joan Krastitel' EAD
        • Contact:
          • Phone Number: 359896660601
        • Principal Investigator:
          • Dimitar Maslarov
      • Sofia, Bulgaria, 1408
        • Recruiting
        • DCC Neoclinic EAD
        • Contact:
          • Phone Number: 359895555797
        • Principal Investigator:
          • Rosen Ikonomov
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic Tokuda University Hospital Ead
        • Contact:
          • Phone Number: 359884933001
        • Principal Investigator:
          • Ivan Staikov
      • Sofia, Bulgaria, 1113
        • Recruiting
        • MHATNP 'Sv.Naum', EAD
        • Contact:
          • Phone Number: 359888707880
        • Principal Investigator:
          • Ivan Gospodinov Milanov
  • Czechia
      • Brno, Czechia, 65691
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
        • Contact:
          • Phone Number: 420543182673
        • Principal Investigator:
          • Michal Dufek
      • Hradec Kralove, Czechia, 50005
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Contact:
          • Phone Number: 420495835214
        • Principal Investigator:
          • Zbysek Pavelek
      • Jihlava, Czechia, 58633
        • Recruiting
        • Nemocnice Jihlava p.o.
        • Contact:
          • Phone Number: 420567157747
        • Principal Investigator:
          • Ondrej Skoda
      • Praha 4-Krc, Czechia, 14059
        • Recruiting
        • Fakultni Thomayerova nemocnice
        • Contact:
          • Phone Number: 420261083584
        • Principal Investigator:
          • Marketa Grunermelova
      • Teplice, Czechia, 41529
        • Recruiting
        • Krajska zdravotni a.s. - Nemocnice Teplice o.z.
        • Contact:
          • Phone Number: 420417519625
        • Principal Investigator:
          • Marta Vachova
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
        • Principal Investigator:
          • Tjalf Ziemssen
        • Contact:
          • Phone Number: 493514584465
    • Baden Wuerttemberg
      • Boeblingen, Baden Wuerttemberg, Germany, 71034
        • Recruiting
        • Studienzentrum fur Neurologie und Psychiatrie
        • Contact:
          • Phone Number: 4970313097300
        • Principal Investigator:
          • Felix Bischof
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
        • Recruiting
        • Klinikum Bayreuth GmbH- Hohe Warte
        • Contact:
          • Phone Number: 499214003440
        • Principal Investigator:
          • Patrick Oschmann
      • Unterhaching, Bayern, Germany, 82008
        • Recruiting
        • Neuropraxis Muenchen Sued
        • Contact:
          • Phone Number: 498945224360
        • Principal Investigator:
          • Klaus Lehmann-Horn
    • Nordrhein Westfalen
      • Duesseldorf, Nordrhein Westfalen, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf AoeR
        • Contact:
          • Phone Number: 492118119532
        • Principal Investigator:
          • Sven Meuth
      • Siegen, Nordrhein Westfalen, Germany, 57076
        • Recruiting
        • ZNS - Zentrum fuer Neurologisch-Psychiatrische Studien
        • Contact:
          • Phone Number: 4927131393710
        • Principal Investigator:
          • Eugen Schlegel
  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Phone Number: 39103537040
        • Principal Investigator:
          • Maria Matilde Inglese
      • Napoli, Italy, 80138
        • Recruiting
        • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
        • Contact:
          • Phone Number: 39815665299
        • Principal Investigator:
          • Antonio Gallo
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Casimiro Mondino
        • Contact:
          • Phone Number: 39382380381
        • Principal Investigator:
          • Elena Colombo
      • Roma, Italy, 00161
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
        • Contact:
          • Phone Number: 39649914556
        • Principal Investigator:
          • Antonella Conte
      • Roma, Italy, 00133
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
        • Contact:
          • Phone Number: 39620903384
        • Principal Investigator:
          • Girolama A. Marfia
    • Isernia
      • Pozzilli, Isernia, Italy, 86077
        • Recruiting
        • I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
        • Contact:
          • Phone Number: 39865929250
        • Principal Investigator:
          • Diego Centonze
    • Palermo
      • Cefalù, Palermo, Italy, 90015
        • Recruiting
        • Fondazione Istituto G.Giglio di Cefalù
        • Principal Investigator:
          • Luigi Grimaldi
        • Contact:
          • Phone Number: +39921920470
  • Poland
      • Gdansk, Poland, 80-803
        • Recruiting
        • COPERNICUS Podmiot Leczniczy Sp. z o. o.,
        • Contact:
          • Phone Number: 48501157820
        • Principal Investigator:
          • Waldemar Fryze
      • Grodzisk Mazowiecki, Poland, 05-825
        • Recruiting
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
        • Contact:
          • Phone Number: 48600952698
        • Principal Investigator:
          • Marta Bilik
      • Katowice, Poland, 40-650
        • Recruiting
        • NZOZ Novo-Med
        • Principal Investigator:
          • Tomasz Jerzy Zielinski
        • Contact:
          • Phone Number: 48322030106
      • Katowice, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia Katowice
        • Contact:
          • Phone Number: 48327494187
        • Principal Investigator:
          • Aleksandra Porosinska
      • Katowice, Poland, 40-571
        • Recruiting
        • M.A. - LEK A.M.Maciejowscy SC.
        • Contact:
          • Phone Number: 48327494187
        • Principal Investigator:
          • Maciej Maciejowski
      • Kielce, Poland, 25-726
        • Recruiting
        • Resmedica Sp.z o.o
        • Contact:
          • Phone Number: 48607570949
        • Principal Investigator:
          • Elzbieta Jasinska
      • Krakow, Poland, 31-637
        • Recruiting
        • MCD Medical
        • Contact:
          • Phone Number: 48123764466
        • Principal Investigator:
          • Stanislaw Rusek
      • Krakow, Poland, 31-503
        • Recruiting
        • Szpital Uniwersytecki w Krakowie
        • Principal Investigator:
          • Agnieszka Slowik
        • Contact:
          • Phone Number: 48124248694
      • Lodz, Poland, 90-324
        • Recruiting
        • Centrum Neurologii K. Selmaj
        • Contact:
          • Phone Number: 48426776678
        • Principal Investigator:
          • Krzysztof Selmaj
      • Oswiecim, Poland, 32-600
        • Recruiting
        • Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
        • Principal Investigator:
          • Magdalena Boczarska-Jedynak
        • Contact:
          • Phone Number: 48604517177
      • Poznan, Poland, 60-693
        • Recruiting
        • Med-Polonia Sp. z o.o.
        • Contact:
          • Phone Number: 48697333515
        • Principal Investigator:
          • Karolina Piasecka-Stryczynska
      • Poznan, Poland, 61-853
        • Recruiting
        • NZOZ 'NEURO-KARD', 'Ilkowski i Partnerzy' Sp. Partn. Lek.
        • Contact:
          • Phone Number: 48618707343
        • Principal Investigator:
          • Jan Ilkowski
      • Rzeszów, Poland, 35-323
        • Recruiting
        • Nzoz Palomed
        • Contact:
          • Phone Number: 48178666981
        • Principal Investigator:
          • Iwona Rosciszewska Zukowska
      • Warszawa, Poland, 01-684
        • Recruiting
        • NeuroProtect Sp. z o.o.
        • Principal Investigator:
          • Maciej Czarnecki
        • Contact:
          • Phone Number: 48501762789
      • Zabrze, Poland, 41-800
        • Recruiting
        • Wielospecjalistyczne Centrum Medyczne Ibismed
        • Contact:
          • Phone Number: 48606607460
        • Principal Investigator:
          • Monika Adamczyk Sowa
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Recruiting
        • Caribbean Center for Clinical Research
        • Contact:
          • Phone Number: 7877937984
        • Principal Investigator:
          • Angel R Chinea Martinez
  • Romania
      • Bucuresti, Romania, 11461
        • Recruiting
        • Spitalul Universitar de Urgență Elias
        • Contact:
          • Phone Number: 40213161600109
        • Principal Investigator:
          • Simona Petrescu
      • București, Romania, 11302
        • Recruiting
        • S.C Neurocity S.R.L
        • Contact:
          • Phone Number: 40723226233
        • Principal Investigator:
          • Dan Mitrea
      • Campulung Muscel, Romania, 115100
        • Recruiting
        • S.C Clubul Sanatatii SRL
        • Contact:
          • Phone Number: 40248533133
        • Principal Investigator:
          • Emilian Silviu Manescu
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Phone Number: 34932483235
        • Principal Investigator:
          • Jose Enrique Martinez Rodriguez
      • Cordoba, Spain, 14011
        • Recruiting
        • Hospital Universitario Reina Sofía
        • Contact:
          • Phone Number: 34688905848
        • Principal Investigator:
          • Eduardo A. Morales
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Phone Number: 34913368397
        • Principal Investigator:
          • Lucienne Costa Frossard Franca
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
        • Contact:
          • Phone Number: 34671957249
        • Principal Investigator:
          • Ana Maria Alonso Torres
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quirónsalud Madrid
        • Principal Investigator:
          • Rafael Arroyo Gonzalez
        • Contact:
          • Phone Number: 34680223584
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Principal Investigator:
          • Jose Eustasio Meca Lallana
        • Contact:
          • Phone Number: 34968369389
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital - Universitaetsspital Bern
        • Contact:
          • Phone Number: 41316329465
        • Principal Investigator:
          • Robert Hoepner
      • Zuerich, Switzerland, 8091
        • Recruiting
        • Universitaetsspital Zuerich
        • Principal Investigator:
          • Patrick Roth
        • Contact:
          • Phone Number: 41442555511
    • Ticino
      • Lugano, Ticino, Switzerland, 6903
        • Recruiting
        • Ospedale Regionale di Lugano
        • Contact:
          • Phone Number: 41918116921
        • Principal Investigator:
          • Chiara Zecca
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • HonorHealth Neurology
        • Contact:
          • Phone Number: 602-406-6262
        • Principal Investigator:
          • Suraj A. Muley
    • California
      • Berkeley, California, United States, 94705
        • Recruiting
        • Alta Bates Summit Medical Center
        • Contact:
          • Phone Number: 510-204-8140
        • Principal Investigator:
          • Joanna A. Cooper
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado School of Medic
        • Contact:
          • Phone Number: 303-724-4172
        • Principal Investigator:
          • Enrique Alvarez
    • Florida
      • Vero Beach, Florida, United States, 32960
        • Recruiting
        • Vero Beach Neurology and Research Institute
        • Contact:
          • Phone Number: 7724927051
        • Principal Investigator:
          • Stuart James Shafer
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Neurological Center
        • Principal Investigator:
          • Ajay Gupta
        • Contact:
          • Phone Number: 260-460-3214
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center Research Institute, Inc.
        • Contact:
          • Phone Number: 913-588-6980
        • Principal Investigator:
          • Sharon G. Lynch
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Recruiting
        • International Neurorehabilitation Institute
        • Principal Investigator:
          • Daniel Becker
        • Contact:
          • Phone Number: 410-828-4629
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
          • Phone Number: 314-362-3293
        • Principal Investigator:
          • Robert T. Naismith
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Recruiting
        • University of New Mexico
        • Contact:
          • Phone Number: 917-318-4982
        • Principal Investigator:
          • Clotilde Hainline
    • New York
      • Patchogue, New York, United States, 11772
        • Recruiting
        • South Shore Neurologic Associates, P.C.
        • Principal Investigator:
          • Mark Gudesblatt
        • Contact:
          • Phone Number: 2246 631-758-1910
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University - School of Medicine - Central
        • Contact:
          • Phone Number: 336-716-3869
        • Principal Investigator:
          • Emily Pharr
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
          • Phone Number: 2166369398
        • Principal Investigator:
          • Devon Scott Conway
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • The Boster Center for Multiple Sclerosis
        • Contact:
          • Phone Number: 614-304-3444
        • Principal Investigator:
          • Aaron L. Boster
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, PC
        • Contact:
          • Phone Number: 901-866-9252
        • Principal Investigator:
          • Lee S. Stein
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • Recruiting
        • The University of Texas Health Science Center San Antonio
        • Contact:
          • Phone Number: 210-450-0500
        • Principal Investigator:
          • Tania Reyna
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics
        • Contact:
          • Phone Number: 608-287-2090
        • Principal Investigator:
          • Christopher C. Luzzio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Diagnosis of RMS [relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)] in accordance with the 2017 Revised McDonald criteria.
  2. Time since MS symptom onset is <20 years.
  3. Must have expanded disability status scale (EDSS) score of 0 through 5.0 at screening and baseline.

  4. 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 to Baseline [Day 1]) with at least 1 relapse during the last 12 months prior to randomization.
    • ≥1 clinical relapse within the past 24 months (but not within 30 days prior to Baseline [Day 1]) and ≥1 new brain MRI lesion (Gd-positive and/or new or enlarging T2 hyperintense lesion) within the past 12 months prior to randomization. The screening MRI could be used to satisfy this criterion (if needed for inclusion, local reading is required). For new or enlarging T2 hyperintense lesions, the reference scan cannot be >12 months prior to randomization.
    • ≥1 GdE lesion on brain MRI within 6 months prior to randomization.

Key Exclusion Criteria:

  1. Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria.
  2. An MS relapse that has occurred within 30 days prior to Baseline (Day 1) or the participant has not stabilized from a previous relapse at the time of screening.

  3. History of severe allergic, anaphylactic reactions or hypersensitivity reaction to BIIB091 or DRF, the excipients contained in the formulation, and if appropriate, any diagnostic 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 contrast agents
  4. Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within the past 4 weeks prior to Baseline.
  5. History or positive test result at screening for human immunodeficiency virus (HIV).
  6. Current or history of hepatitis C infection regardless of viral load.
  7. Current or possible hepatitis B.
  8. Current enrollment or plan to enroll in any other drug, biological, device, clinical study, or treatment with an investigational drug or approved therapy for investigational use within 90 days prior to randomization or 5 half-lives of the drug or therapy, whichever is longer.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: BIIB091 High Dose + Matching Placebo for DRF
Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks.
Drug: Placebo
Administered as specified in the treatment arm.
Drug: BIIB091
Administered as specified in the treatment arm.
Experimental: Part 1: BIIB091 Low Dose + Matching Placebo for DRF
Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks.
Drug: Placebo
Administered as specified in the treatment arm.
Drug: BIIB091
Administered as specified in the treatment arm.
Active Comparator: Part 1: DRF + Matching Placebo for BIIB091
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Drug: Placebo
Administered as specified in the treatment arm.
Drug: DRF
Administered as specified in the treatment arm.
Experimental: Part 2: BIIB091 + DRF Standard Dose
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks.
Drug: BIIB091
Administered as specified in the treatment arm.
Drug: DRF
Administered as specified in the treatment arm.
Experimental: Part 2: BIIB091 + DRF Low Dose
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks.
Drug: BIIB091
Administered as specified in the treatment arm.
Drug: DRF
Administered as specified in the treatment arm.
Active Comparator: Part 2: DRF + Matching Placebo for BIIB091
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Drug: Placebo
Administered as specified in the treatment arm.
Drug: DRF
Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants With Adverse Events (AEs)
Time Frame: Day 1 up to Week 50
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
Day 1 up to Week 50
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From signing the informed consent form (ICF) to Week 50
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
From signing the informed consent form (ICF) to Week 50
Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Time Frame: Week 8 to Week 16
Week 8 to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Time Frame: Week 8 to Week 16
Week 8 to Week 16
Part 1: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
Time Frame: Week 8 to Week 16
Week 8 to Week 16
Part 1: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
Time Frame: Week 8 to Week 16
Week 8 to Week 16
Part 1: Mean Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), RR, PR, QRS, and QT Intervals
Time Frame: Up to Week 50
Up to Week 50
Part 1: Number of Participants With Change From Baseline in Heart Rate
Time Frame: Up to Week 50
Up to Week 50
Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time Frame: Up to Week 50
Up to Week 50
Part 2: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
Time Frame: Week 8 to Week 16
Week 8 to Week 16
Part 2: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
Time Frame: Week 8 to Week 16
Week 8 to Week 16
Part 2: Number of Participants With AEs
Time Frame: Day 1 up to Week 50
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
Day 1 up to Week 50
Part 2: Number of Participants With SAEs
Time Frame: From signing of ICF up to Week 50
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
From signing of ICF up to Week 50
Part 2: Number of Participants With Change From Baseline in QTcF, RR, PR, QRS, and QT intervals
Time Frame: Up to Week 50
Up to Week 50
Part 2: Number of Participants With Change From Baseline in Heart Rate
Time Frame: Up to Week 50
Up to Week 50
Part 2: Number of Participants With ECG Abnormalities as Assessed by 12-Lead ECG Measurements
Time Frame: Up to Week 50
Up to Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

July 10, 2025

Study Completion (Estimated)

November 9, 2026

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 257MS201
  • 2022-502552-31 (Other Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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