Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome
Acer Therapeutics Inc. · NCT05432466
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 15–64 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 150
- US sites recruiting
- 1
- Study start
- November 7, 2022
- Record last updated
- August 24, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ACER-002 (celiprolol) 200 mg BID; Placebo BID
Conditions: Vascular Ehlers-Danlos Syndrome
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Recruiting US locations
Science 37
Culver City, CA 90230
Site contact: Sheila Woodhouse, MD · 984-377-3737 · sheila.woodhouse@science37.com
Study contacts (from the official record)
- Sheila Woodhouse, MD; Ph.D. · 984-377-3737 · sheila.woodhouse@science37.com
- Jonathan Cotliar, MD; Ph.D. · 984-377-3737 · jonathan@science37.com