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NCT02029274 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of BAF312 in Dermatomyositis
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02029274: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02029274 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02029274, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .
Primary Outcome
Each muscles tested was evaluated on a 0 - 10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. The total MMT24 score ranged from 0 - 240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement.
Interventions
- DRUG Placebo
- DRUG BAF312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-08-25 |
| Est. Completion | 2016-02-17 |
| Phase | Phase 2 |
Why NCT02029274 stopped before completion
NCT02029274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02029274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02029274 about?
NCT02029274 is a clinical study titled "Safety and Efficacy of BAF312 in Dermatomyositis". This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind p...
What is the current status of trial NCT02029274?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2013-08-25. Estimated completion is 2016-02-17.
What interventions are being tested in trial NCT02029274?
The interventions under investigation include: Placebo (DRUG), BAF312 (DRUG).
Who is sponsoring clinical trial NCT02029274?
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 NCT02029274's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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