To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (Progress)
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|ClinicalTrials.gov Identifier: NCT05090891|
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : April 19, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Fibrodysplasia Ossificans Progressiva (FOP)||Drug: INCB000928 Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
INCBG000928 will be administered QD orally.
Other Name: INB000928 will be administered QD orally
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.
placebo will be administered QD orally
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years to 99 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
|Study Director:||Kurt Brown, MD||Incyte Corporation|
|Responsible Party:||Incyte Corporation|
|Other Study ID Numbers:||
|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.|
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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
fibrodysplasia ossificans progressiva (FOP)