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Clinical Trials in the USA / NCT05432466
Recruiting Phase 3

Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome

NCT05432466 · tracked via the Priya Life Science USA tracker
Sponsor
Acer Therapeutics Inc.
Phase
Phase 3
Started
2022-11-07
Last updated
2025-08-24

Condition(s) studied

Vascular Ehlers-Danlos Syndrome

Investigational drug(s) / intervention(s)

ACER-002 (celiprolol) 200 mg BIDPlacebo BID

ACER-002 (celiprolol) 200 mg BID: ACER-002 (celiprolol) 200 mg BID

Placebo BID: placebo for ACER-002

Study summary

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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: 1. Willingness to obtain magnetic resonance angiogram (MRA) image at local imaging facility. 2. A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines. 3. Patients must be ≥ 15 years of age at the time of randomization. 4. Able and willing to discontinue use of β-blockers prior to randomization. Exclusion Criteria: 1. 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. 2. Arterial rupture or dissection, uterine rupture, and/or intestinal rupture within 6 months prior to Screening. 3. Patients unable to discontinue β-blocker treatment prior to randomization. 4. Unable or unwilling to complete the study procedures. 5. Breastfeeding, pregnancy, or planned pregnancy during the trial. 6. 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. 7. Use of any prohibited medications

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Science 37 Culver City California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05432466 on ClinicalTrials.gov ↗ ← All trials in the USA