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NCT02279095 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
A Phase 2 study, sponsored by Clementia Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT02279095: Completed Phase 2 study, sponsored by Clementia Pharmaceuticals.
NCT02279095 is a Phase 2 study that has completed, run by Clementia Pharmaceuticals. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02279095, a Phase 2 study, has completed, sponsored by Clementia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP.
Primary Outcome
A responder was defined as a participant with no or minimal new HO at original flare-up site compared with baseline (pre-dose data from PVO-1A-201 study). Minimal new HO was defined as new HO with an HO score \<=3 in both the anterior/posterior (AP) and lateral projections (or if 1 view is noninterpretable or non-evaluable, then remaining evaluable view was used). The HO score ranged from 0 to 6 where, 0 = no HO and 6 = single contiguous HO with longest dimension \>2 diameters of reference normo
Interventions
- DRUG Palovarotene dose level 1
- DRUG Palovarotene dose level 2
- DRUG Palovarotene dose level 3
- DRUG Palovarotene dose level 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-10-09 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 2 |
What the finished NCT02279095 record still lists
NCT02279095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 4 interventions - of which Palovarotene dose level 1 is the first listed.
NCT02279095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02279095 about?
NCT02279095 is a clinical study titled "An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)". Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progres...
What is the current status of trial NCT02279095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-10-09. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT02279095?
The interventions under investigation include: Palovarotene dose level 1 (DRUG), Palovarotene dose level 2 (DRUG), Palovarotene dose level 3 (DRUG), Palovarotene dose level 4 (DRUG).
Who is sponsoring clinical trial NCT02279095?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02279095's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 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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