A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis
Purpose
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.
Condition
- Relapsing Forms of Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
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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. |
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|
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. |
|
|
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. |
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|
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. |
|
|
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. |
|
Recruiting Locations
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
913-588-6980
913-588-6980
More Details
- Status
- Recruiting
- Sponsor
- Biogen