Efficacy and Safety of apraglutide in SBS-IF
Research type
Research Study
Full title
A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)
IRAS ID
281704
Contact name
Farooq Rahman
Contact email
Sponsor organisation
VectivBio AG
Eudract number
2020-001202-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 22 days
Research summary
This phase 3 trial aims to find out whether the study drug, apraglutide, is able to reduce the volume per week of parenteral support (PS) required in adults with short bowel syndrome and intestinal failure.
Apraglutide is a Glucagon-like peptide 2 (GLP-2) analogue, a drug class that facilitates intestinal nutrient absorption by activating pro-absorptive pathways. SBS-IF patients cannot absorb enough nutrients and fluids from the food they eat to stay alive and instead must receive them via injection, so researchers want to see whether apraglutide could help in treating SBS-IF.
Trial participants will be randomly assigned to receive apraglutide or placebo. Participants assigned to the apraglutide treatment group will receive the drug once a week via subcutaneous injection. Participants assigned to the placebo group will receive once-weekly subcutaneous injections of an inactive compound.
The trial will consist of a screening period, comprising an initial screening visit, an optimisation phase and stability testing, followed by a treatment period of 6-12 months and an End of Trial visit 4-6 weeks after the last trial medication dose.
Continuous treatment in a Long-term Safety and Clinical Outcomes Extension Trial (LTE) may be offered to participants at the final planned dosing visit in this trial, allowing participants in the placebo arm to also have the option of receiving apraglutide. The open-label LTE trial will be described in a separate protocol.The trial will be conducted worldwide at about 63 trial clinics, including approximately 2 centres in the UK, with 144 patients participating.
A number of assessments will be performed during the trial including, but not limited to, physical examinations, blood samples, questionnaires, eDiary completion, electrocardiograms and Colonoscopies or Colonographies to determine disease status.
This trial is sponsored by VectivBio AG.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0018
Date of REC Opinion
10 Mar 2021
REC opinion
Further Information Favourable Opinion