RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2022-05-05
Study Completion:2028-04-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05090891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female and male adults and adolescents ≥ 12 years of age with a diagnosis of FOP.
  2. * Willingness to avoid pregnancy or fathering children based on the criteria below.
  3. * Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.
  4. * Further inclusion criteria apply.
  1. * Pregnant or breast-feeding.
  2. * CAJIS score ≥ 24.
  3. * FOP disease severity that in the investigator's opinion precludes participation.
  4. * 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.
  5. * Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
  6. * HIV, HBV, or HCV infection. Note:
  7. * Further exclusion criteria apply.

Contacts and Locations

Study Contact

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

Principal Investigator

Kurt Brown, MD
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

University of California San Francisco Medical Center
San Francisco, California, 94143
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Penn Medicine - Perelman Center For Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Kurt Brown, MD, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-05
Study Completion Date2028-04-28

Study Record Updates

Study Start Date2022-05-05
Study Completion Date2028-04-28

Terms related to this study

Keywords Provided by Researchers

  • fibrodysplasia ossificans progressiva (FOP)
  • heterotopic ossification

Additional Relevant MeSH Terms

  • Fibrodysplasia Ossificans Progressiva (FOP)