Status:
NOT_YET_RECRUITING
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Biogen
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for people with a certain type of amyotrophic lateral...
Detailed Description
The primary objective of this study is to evaluate the safety of tofersen in participants with SOD1-ALS in post marketing setting in China. The secondary objective of this study is to evaluate the ph...
Eligibility Criteria
Inclusion
- Key
- Age ≥ 18 years at the time of informed consent.
- Must have diagnosis of SOD1-ALS.
- If taking riluzole, participant must be on a stable dose for ≥ 30 days prior to Day 1 and expected to remain at that dose until the final study visit.
- If taking edaravone, participant must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study.
- All women of childbearing potential must practice effective contraception during the study.
- Key
Exclusion
- Hypersensitivity to the active substance or any of the excipients of tofersen injection.
- Current or past administration of tofersen injection, in either a commercial or a clinical study setting.
- Prior or current treatment with small interfering ribonucleic acid (RNA), stem cell therapy, or gene therapy.
- Treatment with another investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer, prior the Baseline Visit.
- Participants who are pregnant or currently breastfeeding, and those intending to become pregnant during the study.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07223723
Start Date
December 2 2025
End Date
December 16 2027
Last Update
November 3 2025
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