A Phase 2 interventional study of INCB000928 and Placebo in Fibrodysplasia Ossificans Progressiva (FOP), sponsored by Incyte Corporation. Recruiting at 24 sites in 17 countries. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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).
25 studies on the registry are indexed under Myositis Ossificans; 5 are open to participants now.
This study's planned enrollment of 98 is above the median of 48 across 15 interventional studies indexed under Myositis Ossificans.
Browse Myositis Ossificans studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female and male participants:
Exclusion Criteria:
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.
Drug: INCB000928 · Drug: Placebo
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.
Drug: INCB000928 · Drug: Placebo
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.
Drug: INCB000928 · Drug: Placebo
INCBG000928 will be administered QD orally.
Also known as: zilurgisertib
Placebo will be administered QD orally.
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.
Time frame: Week 24
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.
Time frame: Week 24
Double Blind Period: Total volume 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.
Time frame: 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.
Time frame: Week 24
Double Blind Period: Number of new flares from baseline
Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 48
Pharmacokinetics Parameter: Cmax of INCB000928
Maximum observed concentration.
Time frame: Baseline, Weeks 12, 24, 48 and 76
Pharmacokinetics Parameter: Tmax of INCB000928
Time to maximum concentration.
Time frame: Baseline, Weeks 12, 24, 48 and 76
Pharmacokinetics Parameter: Cmin of INCB000928
Minimum observed concentration.
Time frame: 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
Time frame: Baseline, Weeks 12, 24, 48 and 76
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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