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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05090891
Registration number
NCT05090891
Ethics application status
Date submitted
8/10/2021
Date registered
25/10/2021
Date last updated
19/04/2024
Titles & IDs
Public title
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
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Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
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Secondary ID [1]
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INCB 00928-201
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Universal Trial Number (UTN)
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Trial acronym
Progress
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fibrodysplasia Ossificans Progressiva (FOP)
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Injuries and Accidents
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INCB000928
Treatment: Drugs - placebo
Experimental: Group A: INCB000928 - Participants will receive INCB000928 for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 52 weeks.
Placebo Comparator: Group B: Placebo followed by INCB000928 - Participants will receive placebo for 24 weeks (double-blind period). Participants who completed the double-blind period will receive INCB000928 in the 52 week open-label extension period.
Treatment: Drugs: INCB000928
INCBG000928 will be administered QD orally.
Treatment: Drugs: placebo
placebo will be administered QD orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Double Blind Period: Total volume of new heterotopic ossification (HO)
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Assessment method [1]
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HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Double-blind Period: Total number of new flares
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Assessment method [1]
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Defined as number of new flares compared to baseline during the double-blind period.
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Timepoint [1]
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Baseline, Week 12 and Week 24
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Secondary outcome [2]
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Double-blind Period: Proportion of participants with a clinically meaningful improvement in the flare-related symptoms
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Assessment method [2]
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Flare related symptoms will be assessed by via an electronic PRO during the double-blind period.
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Timepoint [2]
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Baseline, Week 12 and Week 24
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Secondary outcome [3]
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Number of Participants with Treatment Emergent Adverse Events (TEAE)
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Assessment method [3]
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Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
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Timepoint [3]
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Up to 80 weeks
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Eligibility
Key inclusion criteria
- Female and male adults and adolescents = 12 years of age with a 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.
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Minimum age
12
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
- Chronic or current active infectious disease requiring systemic antibiotic,
antifungal, or antiviral treatment.
- HIV, HBV, or HCV infection. Note:
- Further exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/04/2028
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
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Murdoch Children'S Research Institute - Parkville
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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02065 - St Leonards
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Recruitment postcode(s) [2]
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03052 - Parkville
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Recruitment postcode(s) [3]
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02145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Minnesota
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United States of America
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Pennsylvania
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Argentina
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Ciudad Autonoma Buenos Aires
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Brazil
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San Paolo
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Canada
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Ontario
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Chile
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Santiago
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China
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Beijing
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China
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Shanghai
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France
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Paris
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Germany
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Koln
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Italy
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Genova
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Italy
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Rome
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Korea, Republic of
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Seoul
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Mexico
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Tlalpan
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Netherlands
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Amsterdam
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New Zealand
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Auckland
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Portugal
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Lisbon
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Russian Federation
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Irkutsk
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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South Africa
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Cape Town
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Spain
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Madrid
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Turkey
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Izmir
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United Kingdom
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Manchester
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United Kingdom
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Stanmore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Incyte Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT05090891
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kurt Brown, MD
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Address
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Incyte Corporation
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Incyte Corporation Call Center (US)
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Address
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Country
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Phone
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1.855.463.3463
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05090891
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