drugset / Trial / NCT05415410
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
RandomizedParallel-groupSingle-blindTreatment
Summary
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
Timeline
- Start
- 2022-05-25
- Primary completion
- 2024-12-17
- Completion
- 2024-12-17
Outcome
Met primary endpoint
Stopped: “Company decision”
release “positive, primary results up to Day 91 for its Phase II exploratory STARGAZE trial evaluating apraglutide in patients with steroid-refractory gastrointestinal acute Graft-versus-Host Disease” ironwoodpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apraglutide | Peptide | 1.4 mg | Subcutaneous |
| Subject | Apraglutide | Peptide | 3.5 mg | Subcutaneous |
| Subject | Apraglutide | Peptide | 7.6 mg | Subcutaneous |