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

Launched by INCYTE CORPORATION · Oct 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INCB000928 for people with Fibrodysplasia Ossificans Progressiva (FOP), a rare condition that causes bone to form in muscles and other soft tissues. This study is in Phase 2, which means it is testing the treatment's effectiveness, safety, and how well it is tolerated by participants. The trial is currently recruiting individuals aged 12 and older who have been diagnosed with FOP and are willing to participate.

Eligible participants must be able to undergo a specific type of imaging test without needing special support, and they should not be pregnant or breastfeeding. Throughout the trial, participants will receive either the treatment or a placebo (a dummy treatment) without knowing which one they have, to ensure the results are fair and reliable. If you or someone you know is considering participation, it’s important to understand both the potential benefits and the requirements of the study, as well as the commitment involved in attending appointments and following safety guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Female and male participants:
• • Cohort 1: ≥ 12 years of age.
• • Cohort 2: 6 to \< 12 years of age.
• • Cohort 3: 2 to \< 6 years of age (after eDMC review of interim data from Cohort 2).
• • Clinical 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.