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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (PROGRESS)
EU CTIS ID: 2023-504129-38-00
What this study is testing
To determine the efficacy of INCB000928 for the prevention of new HO lesions in participants with FOP.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent/assent: a. For adult participants (≥ 18 years of age), ability to comprehend and willingness to sign an ICF. b. For children (2 to < 12 years of age) and adolescent participants (12 to < 18 years of age), written informed consent of the parent(s) or legal guardian and written assent from the underage participant.
- Female and male participants: a. Cohort 1: ≥ 12 years of age. b. Cohort 2: 6 to < 12 years of age. Cohort 3: 2 to < 6 years of age
- Clinical diagnosis of FOP (based on findings of congenital malformation of the great toes, episodic soft-tissue swelling, and/or progressive HO).
- Participant-reported FOP disease activity within 1 year of the screening visit.
- Ability to swallow and retain orally administered tablets, either whole or crushed and dispersed in foods or liquids, or ability to receive and retain crushed tablets via a feeding tube
- Willingness to avoid pregnancy or fathering children
You likely can't join if
- Pregnant or breast-feeding
- Participation in an investigational drug study for the treatment of FOP or any other indication within 30 days or 5 half-lives (whichever is longer) before baseline (Day 1 visit).
- Planning to receive a live vaccine during the course of the study or within 6 weeks after the last dose of study drug.
- Known or suspected allergy to INCB000928 or any component of the study drug.
- Known history of clinically significant drug or alcohol abuse as defined by the investigator in the l year before baseline (Day 1 visit).
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
See the full eligibility criteria
Who can join
- Informed consent/assent: a. For adult participants (≥ 18 years of age), ability to comprehend and willingness to sign an ICF. b. For children (2 to < 12 years of age) and adolescent participants (12 to < 18 years of age), written informed consent of the parent(s) or legal guardian and written assent from the underage participant.
- Female and male participants: a. Cohort 1: ≥ 12 years of age. b. Cohort 2: 6 to < 12 years of age. Cohort 3: 2 to < 6 years of age
- Clinical diagnosis of FOP (based on findings of congenital malformation of the great toes, episodic soft-tissue swelling, and/or progressive HO).
- Participant-reported FOP disease activity within 1 year of the screening visit.
- Ability to swallow and retain orally administered tablets, either whole or crushed and dispersed in foods or liquids, or ability to receive and retain crushed tablets via a feeding tube
- Willingness to avoid pregnancy or fathering children
- Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.
- Willing and able to comply with study procedures and requirements and attend all study visits as defined in this Protocol.
What rules you out
- Pregnant or breast-feeding
- Participation in an investigational drug study for the treatment of FOP or any other indication within 30 days or 5 half-lives (whichever is longer) before baseline (Day 1 visit).
- Planning to receive a live vaccine during the course of the study or within 6 weeks after the last dose of study drug.
- Known or suspected allergy to INCB000928 or any component of the study drug.
- Known history of clinically significant drug or alcohol abuse as defined by the investigator in the l year before baseline (Day 1 visit).
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- HIV, HBV, or HCV infection
- Participants with laboratory values at screening defined
- Weight < 30 kg at screening (Cohort 1 only).
- The following participants are excluded in France: a. Vulnerable populations according to article L.1121-6 of the French Public Health Code. b. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code. c. Individuals not affiliated with the social security system.
- CAJIS score ≥ 24.
- FOP disease severity that in the investigator's opinion precludes participation
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- 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.
- Presence of a clinically significant finding on echocardiogram
- Presence of an abnormal finding on ECG at screening that in the investigator's opinion is clinically significant and/or the following ECG parameters: QTcF interval > 450 milliseconds, ECG evidence of Brugada syndrome, atrial fibrillation or atrial flutter, or Mobitz II or higher grade atrioventricular block.
- Current treatment with a potent/strong inhibitor or inducer of CYP3A4 within 5 half-lives before the first dose of study treatment or expected to receive such treatment during the study
- Use of the following medications: a. Imatinib 30 days prior to baseline (Day 1 visit). b. Any medication that might interfere with HO formation in the 30 days or 5 half-lives, whichever is shorter before baseline
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Chile
- Mexico
- Korea, Republic of
- Australia
- Canada
- South Africa
- United States
- United Kingdom
- New Zealand
- Argentina
- Brazil
- China
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, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Chile; Mexico; Korea, Republic of; Australia; Canada and 7 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 EU CTIS; the study team decides eligibility.