This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.
Willingness to obtain magnetic resonance angiogram (MRA) image at local imaging facility.
A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines.
Patients must be ≥ 15 years of age at the time of randomization.
Able and willing to discontinue use of β-blockers prior to randomization.
Lack of a COL3A1-positive test at screening (e.g., COL3A1 benign, likely benign, variant of unknown significance [VUS] or no variant) or presence of a COL3A1 variant but demonstration of a COL3A1 variant reported to be a haploinsufficiency variant.
Arterial rupture or dissection, uterine rupture, and/or intestinal rupture within 6 months prior to Screening.
Patients unable to discontinue β-blocker treatment prior to randomization.
Unable or unwilling to complete the study procedures.