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

Conditions

• Vascular Ehlers-Danlos Syndrome

Eligibility Criteria

Sex

ALL

Age

15 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• ACER-002 (celiprolol) 200 mg BID — DRUG
  ACER-002 (celiprolol) 200 mg BID
• Placebo BID — DRUG
  placebo for ACER-002

Study Details

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 Dates

Start date

Nov 7, 2022

Status verified

Aug 2025

Primary completion

Mar 1, 2029

Completion

Apr 1, 2029

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ACER-002 (celiprolol) 200 mg BID
  ACER-002 200 mg twice daily (BID) (after titration): 200 mg morning and 200 mg evening: 400 mg total daily dose Titration: Day 1 to Month 1 - 100 mg once daily (QD) evening: 100 mg total daily dose Month 2 to Month 3 - 100 mg morning and 100 mg evening: 200 mg total daily dose Month 3 to Month 4 - 100 mg morning and 200 mg evening: 300 mg total daily dose Month 4 to End of Treatment Period (BID) - 200 mg morning and 200 mg evening: 400 mg total daily dose
• Experimental: Placebo BID
  Placebo twice daily (BID) Placebo given orally to mimic ACER-002 (celiprolol) administration

Primary Outcome Measure

Time to first occurrence of a vEDS-related clinical event requiring medical attention: Fatal/nonfatal cardiac or arterial events [including dissection or rupture], uterine rupture, intestinal rupture, and/or unexplained sudden death [ Time Frame: Over the double-blind period (estimated to be 40 months) ]

Central Contacts

• Sheila Woodhouse, MD; Ph.D.
  984-377-3737
  [email protected]
• Jonathan Cotliar, MD; Ph.D.
  984-377-3737
  [email protected]

Locations (1)

Find similar trials in Culver City, CA

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