NCT05018286

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: VectivBio AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Detailed description

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Apraglutide	Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2

Timeline

• Start date: 2021-07-13
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2021-08-24
• Last updated: 2025-07-02

Locations

66 sites across 18 countries: United States, Argentina, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study