Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT07301450
Eligibility Criteria:
Key Inclusion Criteria:
1. Adult patients with FOP who must have completed the double-blind treatment period of the parent study OPTIMA (R2477-FOP-2175 \[NCT05394116\]), as defined in the protocol
2. If the patient has progression of disease with Cumulative Analogue Joint Involvement Scale (CAJIS) \>19 at the time of EAP enrollment, the case will require discussion and evaluation between the treating physician and EAP Medical Director to determine final eligibility
Key Exclusion Criteria:
1\. Patients participating in OPTIMA who are considered by the treating physician as inappropriate for this program for any reason
NOTE: Other protocol defined inclusion / exclusion criteria apply
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07301450
Study Brief:
Protocol Section:
NCT07301450