Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome.

Paused · Phase 3 · Has a placebo group

Conditions studied: Vascular Ehlers-Danlos Syndrome

In brief

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.

Key facts

Study ID

NCT05463679

Run by

Aytu BioPharma, Inc.

People needed

260

Starts

2025-01-01

Expected to finish

2027-03-01

Last updated by the study team

2024-03-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Inability to swallow or receive intact tablets.
• Currently being treated with CYP3A4 inhibitors within 4 weeks prior to enrollment.
• Known allergy or hypersensitivity to enzastaurin.
• Patient currently pregnant or breast feeding.
• Other criteria will be reviewed at the first study visit to determine if you are able to participate in the study.

Where it is running

• Aytu BioPharma — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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