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Tests treatment safety and results for Fibrodysplasia Ossificans Progressiva (FOP)
Official title To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
ClinicalTrials.gov ID: NCT05090891
What this study is testing
What is INCB000928?
INCB000928 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fibrodysplasia ossificans progressiva (fop).
Also referred to as zilurgisertib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 99
You may be able to join if
- Female and male participants:
- Cohort 1: ≥ 12 years of age.
- Cohort 2: 6 to \< 12 years of age.
- Cohort 3: 2 to \< 12 years of age (after eDMC review of safety data from Cohort 2).
- Clinical diagnosis of FOP.
You likely can't join if
- Pregnant or breast-feeding.
- CAJIS score ≥ 24.
- FOP disease severity that in the investigator's opinion precludes participation.
- Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the...
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- HIV, HBV, or HCV infection. Note:
See the full eligibility criteria
- Female and male participants:
- Cohort 1: ≥ 12 years of age.
- Cohort 2: 6 to \< 12 years of age.
- Cohort 3: 2 to \< 12 years of age (after eDMC review of safety data from Cohort 2).
- Clinical diagnosis of FOP.
- Willingness to avoid pregnancy or fathering children based on the criteria below.
- Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.
- Further apply.
- Pregnant or breast-feeding.
- CAJIS score ≥ 24.
- FOP disease severity that in the investigator's opinion precludes participation.
- Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with...
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- HIV, HBV, or HCV infection. Note:
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Philadelphia, Pennsylvania, United States
- Buenos Aires, Argentina
- St Leonards, New South Wales, Australia
- Parkville, Victoria, Australia
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Santiago, Chile
- Beijing, China
- Shanghai, China
- Paris, France
- Cologne, Germany
- Rome, Italy
- Tlalpan, Mexico
- Amsterdam, Netherlands
- Auckland, New Zealand
- Cape Town, South Africa
- Seoul, South Korea
- Madrid, Spain
- Stanmore, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Philadelphia, Pennsylvania, United States; Buenos Aires, Argentina; St Leonards, New South Wales, Australia; Parkville, Victoria, Australia; São Paulo, Brazil and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.