A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome (vEDS) Confirmed With COL3A1 Mutations, Followed by an Open Label Extension (OLE)

Status: Suspended
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: No
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• Subjects aged 18 - 60 years old at time of initial screening.

• Adolescent subjects aged 12 - 17 years old, may be considered to enroll later in the clinical trial pending interim analysis.

• Diagnosis for VEDS (vascular Ehlers Danlos Syndrome), with a confirmed and documented COL3A1 genetic variant.

• Subject should be stable, having no VEDS-related vascular events within the past 3 months prior to enrollment.

• Confirmed use of contraception for both male and female participants.

Locations
United States
Colorado
Aytu BioPharma
Englewood
Time Frame
Start Date: January 2024
Completion Date: March 2027
Participants
Target number of participants: 260
Treatments
Active Comparator: Enzastaurin 500 mg QD
Receive 500 mg enzastaurin QD plus background standard of care.
Placebo Comparator: Placebo QD
Matching placebo QD plus background standard of care.
Authors
Shaine Morris, Sherene Shalhub
Sponsors
Leads: Aytu BioPharma, Inc.
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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