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NCT02250443 · ClinicalTrials.gov registry record · Phase 2
Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02250443 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 10 participants.
The verdict
NCT02250443, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing. However due to lack of efficacy in patients with sIBM, the study was terminated early.
Interventions
- DRUG BYM338 (Bimagrumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-03-11 |
| Est. Completion | 2016-08-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02250443
The ClinicalTrials.gov registry entry for NCT02250443 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BYM338 (Bimagrumab) is the first listed.
NCT02250443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02250443 about?
NCT02250443 is a clinical study titled "Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis". This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to confirm the efficacy, sa...
What is the current status of trial NCT02250443?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-03-11. Estimated completion is 2016-08-23.
What interventions are being tested in trial NCT02250443?
The interventions under investigation include: BYM338 (Bimagrumab) (DRUG).
Who is sponsoring clinical trial NCT02250443?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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