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Monoclonal Antibodies
A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3
Phase 1
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 267
Summary
This trial tests the safety and effectiveness of BIIB132, an experimental drug, in patients with spinocerebellar ataxia type 3 (SCA3). The drug works by lowering a specific protein to slow disease progression.
Eligible Conditions
- Spinocerebellar Ataxia Type 3
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 267
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 267
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs)
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5: BIIB132 Dose 5 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 5 or matching placebo, IT, either Q4W or every 12 weeks (Q12W), up to Day 85 or every 8 weeks (Q8W) up to Day 57.
Group II: Cohort 4: BIIB132 Dose 4 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 4 or matching placebo, IT, Q4W, up to Day 85.
Group III: Cohort 3: BIIB132 Dose 3 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 3 or matching placebo, IT, Q4W, up to Day 85.
Group IV: Cohort 2: BIIB132 Dose 2 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 2 or matching placebo, IT, Q4W, up to Day 85.
Group V: Cohort 1: BIIB132 Dose 1 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 1 or matching placebo, intrathecally (IT), every 4 weeks (Q4W), up to Day 85.
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Who is running the clinical trial?
BiogenLead Sponsor
648 Previous Clinical Trials
467,494 Total Patients Enrolled
2 Trials studying Spinocerebellar Ataxias
168 Patients Enrolled for Spinocerebellar Ataxias
Medical DirectorStudy DirectorBiogen
2,905 Previous Clinical Trials
8,091,461 Total Patients Enrolled