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A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)

Study acronym: OPTIMA-2
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Dec 10, 2028 → Jul 8, 2030
Primary endpoints removed 5 → 3 primary endpoints
See other at-risk trials from Regeneron

Record History

  1. Primary completion pushed from Dec 10, 2028 to Jul 8, 2030 Primary endpoint(s) modified · Completion pushed from Dec 21, 2029 to Jul 8, 2030 · Eligibility criteria expanded, about 55 words · 1 more Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Completion pushed from Dec 21, 2029 to Jul 8, 2030
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints revised (16)
  2. Start date: Jul 30, 2026 to Feb 2, 2027v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Regeneron
151 trials monitored
See 16 trials at risk
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on children and adolescent participants with FOP. For United States: Ages 4 to less than 18 years; for non-US sites only: Ages 2 to less than 18 years. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Trial Details
NCT Number NCT07559513
Lead Sponsor Regeneron Pharmaceuticals
Conditions Fibrodysplasia Ossificans Progressiva, FOP
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov