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

ConditionFibrodysplasia Ossificans Progressiva (FOP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-99
SponsorIncyte Corporation

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 interpretation of study data.

Trial design

Design model

Parallel

Treatments tested in this trial

  • INCB000928

    Drug

    INCBG000928 will be administered QD orally.

  • Placebo

    Drug

    Placebo will be administered QD orally.

Treatment groups

98 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Double Blind Period: Number of new flares from baseline

Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT).

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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