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

(Progress)

Sponsored by Incyte Corporation

Quick Self-Assessment

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Dec 5, 2025

Phase

Clinical Trial

Sponsor

Incyte Corporation

Enrollment Target

98

Start Date

May 2022

๐Ÿ“Š
1 of 98 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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).

Who Can Participate

Inclusion Criteria

Female and male participants:
Cohort 1: โ‰ฅ 12 years of age.
Cohort 2: 6 to \< 12 years of age.
Cohort 3: 2 to \< 6 years of age (after eDMC review of interim 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 inclusion criteria apply.

Exclusion Criteria

Pregnant or breast-feeding.
CAJIS score โ‰ฅ 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 interpretation of study data.
Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
HIV, HBV, or HCV

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

98 participants

๐ŸŽ‚

Age Range

2 Years - 99 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Incyte Corporation

Study Locations

Choose your preferred location or select flexible during enrollment

WITHDRAWN

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page
ACTIVE_NOT_RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Fibrodysplasia Ossificans Progressiva Treatment in San Francisco?

Join others in California exploring innovative treatment options through clinical research

Fibrodysplasia Ossificans Progressiva Treatment Options in San Francisco, California

If you're searching for Fibrodysplasia Ossificans Progressiva treatment in San Francisco, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Francisco, Rochester, Philadelphia and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Fibrodysplasia Ossificans Progressiva. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 98 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Fibrodysplasia Ossificans Progressiva?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Fibrodysplasia Ossificans Progressiva

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Fibrodysplasia Ossificans Progressiva Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05090891. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.