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NCT03188666 · ClinicalTrials.gov registry record · Phase 2
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT03188666 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 44 participants.
The verdict
NCT03188666, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3). Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in male and female patients with fibrodysplasia ossificans progressiva (FOP). Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of HO lesions by computed tomography (CT). Key Secondary objectives are: * To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the area under the curve (AUC) for pain based on daily pain numeric rating scale (NRS) scores * To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as determined by the number of new HO lesions identified by 18F-NaF PET or by CT * To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET * To assess the effect of REGN2477, between week 28 and week 56, on the number, activity, and volume of HO lesions identified by 18F-NaF PET or by CT in patients who switch from placebo to REGN2477 at week 28 versus the same patients between baseline and week 28 * To assess the effect of REGN2477 versus placebo on the change from baseline in biochemical markers of bone formation * To characterize the concentrations of total activin A at baseline and over time following the first dose of study drug * To characterize the concentration-time profile (pharmacokinetics \[PK\]) of REGN2477 in patients with FOP * To assess the immunogenicity of REGN2477
Interventions
- DRUG Matching placebo
- DRUG REGN2477
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-02-26 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03188666
The ClinicalTrials.gov registry entry for NCT03188666 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT03188666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03188666 about?
NCT03188666 is a clinical study titled "A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva". This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3). Primary safety objective of the study is to assess the safety and tolerab...
What is the current status of trial NCT03188666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2018-02-26. Estimated completion is 2021-09-16.
What interventions are being tested in trial NCT03188666?
The interventions under investigation include: Matching placebo (DRUG), REGN2477 (DRUG).
Who is sponsoring clinical trial NCT03188666?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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