Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)

This is an interventional treatment trial for Relapsing Multiple Sclerosis Read More

Key Inclusion Criteria:

• Diagnosed with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS)
• Have a Baseline Expanded Disability Status Scale (EDSS) score of 2.0 to 6.0
• Have a MS disease duration of ≤20 years from first MS symptom(s)
• Must have at least one of the following occurring within 12 months prior to

Day 1/Baseline:

(a) ≥1 clinical relapse(s) or objective disability worsening (as per treating neurologist's judgment) (b) ≥1 Gadolinium (Gd)-enhancing T1 lesion(s) on brain or spinal cord Magnetic Resonance Imaging (MRI) (c) ≥1 new T2 lesion(s) on brain or spinal cord MRI (the reference scan used to detect new T2 lesion formation has to be ≤12 months prior to Day 1/Baseline)

• Must have been taking one of the following disease-modifying therapy (DMTs) at a stable dose for at least 12 weeks prior to Day 1/Baseline:

  1. Interferon-beta1 (IFN-β1): Avonex, Plegridy, Betaferon/Betaseron, Extavia, or Rebif

  2. Glatiramer acetate (Copaxone or Glatopa).

     Key Exclusion Criteria:

• A documented history of clinically significant persistent neutralizing antibody against IFN-β1 (applicable only for participants entering the study with IFN-β1 as a background DMT), in the opinion of the Investigator
• Contraindications to MRI, for example, presence of pacemakers or other implanted metal devices (excluding dental braces), an allergy to Gd, renal impairment, or claustrophobia that cannot be medically managed
• History or a positive test result at Screening for human immunodeficiency virus
• Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody and detectable HCV Ribonucleic acid (RNA)). Participants with positive HCV antibody and undetectable HCV RNA are eligible to participate in the study (United States [US] Centers for Disease Control and Prevention)
• Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] or total hepatitis B core antibody [anti-HBc]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study
• History of systemic hypersensitivity reaction to BIIB061
• History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 12 weeks of screening
• Clinically significant (as determined by the Investigator) 12-lead ECG or laboratory assessment abnormalities
• Any condition affecting study treatment absorption (e.g., gastrectomy)
• Treatment with statins (3-hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors) or proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors (e.g., alirocumab and evolocumab) within 8 weeks prior to Day 1/Baseline
• Inability or unwillingness to comply with study requirements
• Other unspecified reasons that, in the opinion of the Investigator or Biogen that make the participant unsuitable for enrollment.

Note: Other protocol defined inclusion/ exclusion criteria may apply.