Status:
TERMINATED
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Biogen
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective is to evaluate the long-term safety and tolerability of BIIB078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (C9ORF72-ALS). The secondar...
Detailed Description
This study is an extension study of NCT03626012.
Eligibility Criteria
Inclusion
- Key
- Participants must have completed study NCT03626012 through the first follow-up clinic visit that follows the final dosing visit without missing more than 1 dose of study treatment.
- Participants taking concomitant riluzole at study entry must be on a stable dose for ≥30 days prior to the first dose of study treatment (Day 1). Participants taking concomitant riluzole must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that riluzole should be discontinued for medical reasons, in which case it may not be restarted during the study.
- Participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (Day 1). Participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study.
- Key
Exclusion
- History of drug abuse or alcoholism ≤6 months before study enrollment that would limit participation in the study, as determined by the Investigator.
- Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter.
- History of or positive test result at Screening for human immunodeficiency virus. The requirement for testing at Screening may be omitted if it is not permitted by local regulations.
- Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs) or biological agent within 1 month of Screening or 5 half-lives of study agent, whichever is longer.
- Note: Other protocol-specific inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04288856
Start Date
April 28 2020
End Date
May 3 2022
Last Update
April 18 2023
Active Locations (21)
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1
Research Site
La Jolla, California, United States, 92037
2
Research Site
Los Angeles, California, United States, 90048
3
Research Site
Palo Alto, California, United States, 94304
4
Research Site
Jacksonville, Florida, United States, 32224