NCT05415410

Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)

A Randomized, Single-blind Trial to Evaluate the Safety and Efficacy of Apraglutide in Subjects With Grade II to IV (MAGIC) Steroid Refractory Gastrointestinal (GI) Acute Graft Versus Host Disease on Best Available Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: VectivBio AG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.

Detailed description

This is an international, multicenter, randomized proof-of-concept trial to evaluate safety, tolerability, efficacy, durability of response, and clinical outcomes of apraglutide administration to subjects with steroid-refractory (SR) aGVHD of the lower GI tract being treated with systemic steroids (SS) and ruxolitinib (RUX).

Conditions

• GVHD

Interventions

Type	Name	Description
DRUG	Apraglutide	Apraglutide is a new, synthetic glucagon-like peptide 2 (GLP-2) receptor agonist which acts as a gut targeted regenerative approach that is intestinotrophic with a mode of action that improves absorption and enhances gut barrier function.

Timeline

• Start date: 2022-05-25
• Primary completion: 2024-12-17
• Completion: 2024-12-17
• First posted: 2022-06-13
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

13 sites across 4 countries: United States, Germany, Portugal, Spain

Regulatory

• FDA-regulated drug study