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NCT03312634 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.

A Phase 3 study, sponsored by Clementia Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
107
Enrollment target

NCT03312634: Completed Phase 3 study, sponsored by Clementia Pharmaceuticals.

NCT03312634 is a Phase 3 study that has completed, run by Clementia Pharmaceuticals. The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03312634, a Phase 3 study, has completed, sponsored by Clementia Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
107 participants
Enrollment target

Study Summary

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movement and disability.

Primary Outcome

The annualized new HO was assessed by low-dose, whole body computed tomography (WBCT), excluding head. The weighted linear mixed effect method without square-root transformation and negatives included was used for annualized new HO analysis.

Interventions

  • DRUG Palovarotene

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2017-11-30
Est. Completion 2022-09-07
Phase Phase 3
Clementia Pharmaceuticals

8 total trials

What the finished NCT03312634 record still lists

NCT03312634 is an interventional study that assigns participants to a tested intervention. The registered 107 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 (86% lower).

The record links to 0 conditions, and to 1 intervention - of which Palovarotene is the first listed.

NCT03312634 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03312634 about?

NCT03312634 is a clinical study titled "An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.". Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movem...

What is the current status of trial NCT03312634?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2017-11-30. Estimated completion is 2022-09-07.

What interventions are being tested in trial NCT03312634?

The interventions under investigation include: Palovarotene (DRUG).

Who is sponsoring clinical trial NCT03312634?

This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03312634's enrollment target sits among peer trials

107 1666th of 2000 higher than 335 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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Source: ClinicalTrials.gov NCT03312634, the US trial registry maintained by the National Library of Medicine. NCT03312634 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.