Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome
NCT05432466 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-08-24
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.
Conditions
- Vascular Ehlers-Danlos Syndrome
Interventions
- DRUG
-
ACER-002 (celiprolol) 200 mg BID
ACER-002 (celiprolol) 200 mg BID
- DRUG
-
Placebo BID
placebo for ACER-002
Sponsors & Collaborators
-
Acer Therapeutics Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-07
- Primary Completion
- 2029-03-01
- Completion
- 2029-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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