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Trial record 1 of 19 for:    Fibrodysplasia Ossificans Progressiva
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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (Progress)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05090891
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Fibrodysplasia Ossificans Progressiva (FOP) Drug: INCB000928 Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 5, 2022
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 2, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: INCB000928
INCBG000928 will be administered QD orally.
Other Name: INB000928 will be administered QD orally

Drug: placebo
placebo will be administered QD orally
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.
 Drug: placebo
placebo will be administered QD orally


Outcome Measures
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Primary Outcome Measures :
  1. Double Blind Period: Total volume of new heterotopic ossification (HO) [ Time Frame: Week 24 ]
    HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period.


Secondary Outcome Measures :
  1. Double-blind Period: Total number of new flares [ Time Frame: Baseline, Week 12 and Week 24 ]
    Defined as number of new flares compared to baseline during the double-blind period.

  2. Double-blind Period: Proportion of participants with a clinically meaningful improvement in the flare-related symptoms [ Time Frame: Baseline, Week 12 and Week 24 ]
    Flare related symptoms will be assessed by via an electronic PRO during the double-blind period.

  3. Number of Participants with Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to 80 weeks ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05090891


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kurt Brown, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05090891    
Other Study ID Numbers: INCB 00928-201
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: 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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
fibrodysplasia ossificans progressiva (FOP)
heterotopic ossification
Additional relevant MeSH terms:
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Myositis Ossificans
Myositis
Muscular Diseases
Musculoskeletal Diseases