ACTIVE_NOT_RECRUITING

A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)

Conditions

Relapsing Forms of Multiple Sclerosis Multiple Sclerosis Diroximel fumarate BIIB091

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, a different set of participants will take either a combination of BIIB091 and DRF or DRF alone. The goal of the study is to learn more about the safety of BIIB091 and to compare the effects of the study drug when taken alone or together with DRF. The main question researchers are trying to answer are: * How many participants have new or worsening medical problems (adverse events) after taking BIIB091 or DRF? * How many new areas of inflammation occur in the brain after treatment with BIIB091 and DRF? Researchers will use magnetic resonance imaging (MRI) scans to compare images of the brain before and after treatment. They will also explore the effect of BIIB091 and DRF on the heart using electrocardiograms (ECGs). The study will be done as follows: * After screening, participants who joined Part 1 will be randomly assigned to receive either a high or low dose of BIIB091, or the standard dose of DRF. * The results of Part 1 will be used to choose the best dose of BIIB091 to use in Part 2. * Participants who join Part 2 will be randomly assigned to receive either a standard dose of DRF, a combo of BIIB091 and the standard dose of DRF, or a combo of BIIB91 with a low dose of DRF. * Neither the researchers nor the participants will know which drug or dose the participants will receive in either part of the study. * The treatment period will last 48 weeks in each part of the study. Participants will take the drugs by mouth 2 times a day. * Each part will also have a follow-up safety period that lasts up to 2 weeks. * In total, participants in each part will have 20 study visits, or more if they have a relapse. The total study duration for participants will be up to 54 weeks.

Official Title

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

Quick Facts

Study Start:2023-07-25

Study Completion:2027-09-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05798520

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.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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 of human immunodeficiency virus (HIV) infection or a positive or indeterminate test result at screening for HIV. 6. Current or history of hepatitis C infection regardless of viral load. 7. Current or history of hepatitis B infection. 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.

Inclusion Criteria

Exclusion 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.

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 of human immunodeficiency virus (HIV) infection or a positive or indeterminate test result at screening for HIV.
6. Current or history of hepatitis C infection regardless of viral load.
7. Current or history of hepatitis B infection.
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.

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Biogen

Study Locations (Sites)

HonorHealth Neurology

Scottsdale, Arizona, 85251

United States

Alta Bates Summit Medical Center

Berkeley, California, 94705

United States

University of California at Irvine Medical Center

Orange, California, 92868

United States

University of Colorado School of Medic

Aurora, Colorado, 80045

United States

University of Miami Miller School of Medicine

Miami, Florida, 33136

United States

University of South Florida

Tampa, Florida, 33612

United States

Vero Beach Neurology and Research Institute

Vero Beach, Florida, 32960

United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804

United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160

United States

International Neurorehabilitation Institute

Lutherville, Maryland, 21093

United States

Washington University

St Louis, Missouri, 63110

United States

Holy Name

Teaneck, New Jersey, 07666

United States

University of New Mexico

Albuquerque, New Mexico, 87131-0001

United States

South Shore Neurologic Associates, P.C.

Patchogue, New York, 11772

United States

Wake Forest University - School of Medicine - Central

Winston-Salem, North Carolina, 27157

United States

University of Cincinnati Physicians Company

Cincinnati, Ohio, 45267

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

The Boster Center for Multiple Sclerosis

Columbus, Ohio, 43235

United States

Neurology Clinic, PC

Cordova, Tennessee, 38018

United States

Vanderbilt MS Center

Nashville, Tennessee, 37215

United States

The University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229-3900

United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Biogen

Medical Director, STUDY_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 Registration Dates

Study Start Date2023-07-25

Study Completion Date2027-09-07

Study Record Updates

Study Start Date2023-07-25

Study Completion Date2027-09-07

Terms related to this study

Keywords Provided by Researchers

Multiple Sclerosis
Diroximel fumarate
BIIB091

Additional Relevant MeSH Terms

Relapsing Forms of Multiple Sclerosis