Learn more about the INCB000928 trial that may be of interest to you
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) in the United States.
Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the site (that is, registered) when they begin, and the information on the site is updated throughout the study.
Incyte recently submitted the INCB000928 trial to ClinicalTrials.gov. The trial is a phase II study to assess the efficacy and safety of the oral drug INCB000928.
The randomized, double-blind, placebo-controlled study will recruit 60 participants ages 12 and older. For the first 24 weeks, patients will be randomly assigned to take INCB000928 or placebo. After the first 24 weeks, those on placebo will begin receiving INCB000928 and will continue for a 52-week open-label extension period. The total length of the trial is approximately 19 months.
Trial locations have not yet been announced. The enrollment date when patients can sign up to participate in the trial will be announced at a later date.
Every clinical trial includes inclusion and exclusion criteria. Inclusion criteria are the characteristics that a person must have in order to participate in a trial. Exclusion criteria are the reasons why a person cannot participate in a trial. The initial INCB000928 inclusion/exclusion criteria are listed below. To see full details of the trial, click here.
- 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.
* The cumulative analogue joint involvement scale (CAJIS) is a simple, rapidly-administered functional mobility assessment of FOP performed by a physician. The CAJIS score provides an accurate and reproducible snapshot of total body and regional mobility burden in FOP.