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NCT01925209 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 251
- Enrollment target
NCT01925209: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01925209 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 251 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925209, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 251 participants
- Enrollment target
Study Summary
This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).
Primary Outcome
The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
Interventions
- DRUG Placebo
- DRUG BYM338/bimagrumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2013-09-26 |
| Est. Completion | 2016-01-06 |
| Phase | Phase 2 |
What the finished NCT01925209 record still lists
NCT01925209 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01925209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01925209 about?
NCT01925209 is a clinical study titled "Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients". This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).
What is the current status of trial NCT01925209?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 251 participants. The study started on 2013-09-26. Estimated completion is 2016-01-06.
What interventions are being tested in trial NCT01925209?
The interventions under investigation include: Placebo (DRUG), BYM338/bimagrumab (DRUG).
Who is sponsoring clinical trial NCT01925209?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01925209's enrollment target sits among peer trials
251 222nd of 2000 higher than 1,779 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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