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NCT03070119 · ClinicalTrials.gov registry record · Phase 3
Long-Term Evaluation of BIIB067 (Tofersen)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
NCT03070119 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 139 participants.
The verdict
NCT03070119, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), biomarker effects, and efficacy of BIIB067 administered to participants with ALS and a confirmed SOD1 mutation.
Interventions
- DRUG Tofersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03070119
The ClinicalTrials.gov registry entry for NCT03070119 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tofersen is the first listed.
NCT03070119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03070119 about?
NCT03070119 is a clinical study titled "Long-Term Evaluation of BIIB067 (Tofersen)". The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK), pharmacodyna...
What is the current status of trial NCT03070119?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2017-03-08. Estimated completion is 2024-08-12.
What interventions are being tested in trial NCT03070119?
The interventions under investigation include: Tofersen (DRUG).
Who is sponsoring clinical trial NCT03070119?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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