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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: Completed Phase 3 study, sponsored by Biogen.
NCT03070119 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 139 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untowar
Interventions
- DRUG Tofersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 3 |
What the finished NCT03070119 record still lists
NCT03070119 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Tofersen is the first listed.
NCT03070119 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03070119's enrollment target sits among peer trials
139 1577th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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