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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

NCT05090891 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-05-22

No results posted yet for this study

Summary

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

Conditions

  • Fibrodysplasia Ossificans Progressiva (FOP)

Interventions

DRUG

INCB000928

INCBG000928 will be administered QD orally.

DRUG

Placebo

Placebo will be administered QD orally.

Sponsors & Collaborators

Principal Investigators

  • Amanda McBride, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2027-07-30
Completion
2033-01-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090891 on ClinicalTrials.gov