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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504129-38-00 | Registry Identifier | EU CT Number | |
| 2021-002286-17 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants (≥ 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks. |
|
| Cohort 2 | Experimental | Participants (6 to < 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks. |
|
| Cohort 3 | Experimental | Participants (2 to < 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB000928 | Drug | INCBG000928 will be administered QD orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Double Blind Period: Occurrence of new heterotopic ossification (HO) lesions from baseline | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Double Blind Period: Number of new HO lesions from baseline | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. | Week 24 |
| Double Blind Period: Total volume of new HO lesions from baseline |
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Inclusion Criteria:
Female and male participants:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Amanda McBride, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States | |
| Children'S Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41360500 | Derived | Yang YO, Fang Y, Wang P, Liu X, Getsy J, Rockich K. Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib. Br J Clin Pharmacol. 2026 May;92(5):1339-1351. doi: 10.1002/bcp.70372. Epub 2025 Dec 8. |
| Label | URL |
|---|---|
| To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (Progress) | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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| Placebo | Drug | Placebo will be administered QD orally. |
|
HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. |
| Week 24 |
| Double Blind Period: Change in the total volume of all HO lesions from baseline | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. | Week 24 |
| Double Blind Period: Number of new flares from baseline | Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT). | Week 24 |
| Number of Participants with Treatment Emergent Adverse Events (TEAE) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to 316 weeks |
| Open-Label Extension: Occurrence of new HO lesions from Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. | Week 48 |
| Open-Label Extension: Number of new HO lesions from Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. | Week 48 |
| Open-Label Extension: Total volume of new HO lesions from Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. | Week 48 |
| Open-Label Extension: Change in the total volume of all HO lesions from Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. | Week 48 |
| Open-Label Extension: Number of new flares from Week 24 | Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. | Week 48 |
| Pharmacokinetics Parameter: Cmax of INCB000928 | Maximum observed concentration. | Baseline, Weeks 12, 24, 48 and 76 |
| Pharmacokinetics Parameter: Tmax of INCB000928 | Time to maximum concentration. | Baseline, Weeks 12, 24, 48 and 76 |
| Pharmacokinetics Parameter: Cmin of INCB000928 | Minimum observed concentration. | Baseline, Weeks 12, 24, 48 and 76 |
| Pharmacokinetics Parameter: AUCt of INCB000928 | Area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration | Baseline, Weeks 12, 24, 48 and 76 |
| Recruiting |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Penn Medicine - Perelman Center For Advanced Medicine | Active, not recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital Italiano de Buenos Aires | Active, not recruiting | Buenos Aires | CO 1181 | Argentina |
| Royal North Shore Hospital | Completed | St Leonards | New South Wales | 02065 | Australia |
| Murdoch Children'S Research Institute | Active, not recruiting | Parkville | Victoria | 03052 | Australia |
| Albert Einstein Israelite Hospital | Active, not recruiting | São Paulo | 05652-900 | Brazil |
| University Health Network Toronto General Hospital | Active, not recruiting | Toronto | Ontario | M5G 2N2 | Canada |
| Centro de Estudios Reumatologicos | Active, not recruiting | Santiago | 7501126 | Chile |
| Beijing Childrens Hospital Capital Medical University | Recruiting | Beijing | 100045 | China |
| Tongji Hospital of Tongji University | Recruiting | Shanghai | 200065 | China |
| Shanghai Childrens Medical Center | Recruiting | Shanghai | 200127 | China |
| Childrens Hospital of Fudan University | Recruiting | Shanghai | 201102 | China |
| Ap-Hp Hopital Lariboisiere | Recruiting | Paris | 75010 | France |
| Hopital Necker-Enfants Malades | Recruiting | Paris | 75015 | France |
| Uniklinik Koln | Recruiting | Cologne | 50931 | Germany |
| Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore | Active, not recruiting | Rome | 00168 | Italy |
| Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra | Active, not recruiting | Tlalpan | 14389 | Mexico |
| Amsterdam Umc - Vu Medisch Centrum (Vumc) | Recruiting | Amsterdam | 1081 HV | Netherlands |
| Starship Childrens Hospital | Active, not recruiting | Auckland | 01023 | New Zealand |
| Groote Schuur Hospital Radiation Oncology | Active, not recruiting | Cape Town | 07925 | South Africa |
| Seoul National University Hospital | Active, not recruiting | Seoul | 03080 | South Korea |
| Hospital Universitario Ramon Y Cajal | Recruiting | Madrid | 28034 | Spain |
| Royal National Orthopaedic Hospital | Active, not recruiting | Stanmore | HA7 4LP | United Kingdom |
| ID | Term |
|---|---|
| D009221 | Myositis Ossificans |
| D009999 | Ossification, Heterotopic |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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