Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Vascular Ehlers-Danlos Syndrome
In brief
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.
Key facts
- Study ID
- NCT05432466
- Run by
- Acer Therapeutics Inc.
- People needed
- 150
- Starts
- 2022-11-07
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2025-08-24
Who can join
Age: 15 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Breastfeeding, pregnancy, or planned pregnancy during the trial.
- Any medical condition that in the opinion of the Investigator may pose a safety risk to the patient in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
- Use of any prohibited medications
Where it is running
- Science 37 — Culver City, California, United States (enrolling)
Full record on ClinicalTrials.gov
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