Apraglutide Open-Label Phase 3 Extension Trial

  • Research type

    Research Study

  • Full title

    An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome

  • IRAS ID

    1004590

  • Contact name

    Jan Richter

  • Contact email

    jan.richter@vectivbio.com

  • Sponsor organisation

    VectivBio AG

  • Eudract number

    2020-005513-41

  • Clinicaltrials.gov Identifier

    NCT05018286

  • Research summary

    This phase 3 extension trial follows on from the parent trial Efficacy and Safety of apraglutide in SBS-IF (IRAS ID: 281704) and aims to find out how safe, tolerable and effective the trial drug, apraglutide, is when it is given to adults with short bowel syndrome and intestinal failure (SBS-IF) in the long term. Apraglutide is a Glucagon-like peptide 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 infusion. In the abovementioned parent trial, all individuals who will participate in this extension trial received treatment with apraglutide or placebo for 6-12 months, depending on whether they were in the stoma or colon-in-continuity group, and now researchers want to see whether apraglutide could help in treating SBS-IF over an extended period. All participants in this trial will receive treatment with apraglutide once a week via subcutaneous injection regardless of whether they were assigned to receive apraglutide or placebo in the parent trial. This trial will consist of a screening period, where the eligibility of potential participants will be evaluated using results from tests performed at one of the scheduled visits in the final 5 weeks of the parent trial mentioned above, a treatment period of up to two years and an End of Trial visit 3-5 weeks after the last trial medication dose. The trial will be conducted worldwide at about 70 trial clinics, including approximately 3 centres in the UK, with 138 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.

  • REC name

    East of Scotland Research Ethics Service REC 2

  • REC reference

    22/ES/0013

  • Date of REC Opinion

    31 Mar 2022

  • REC opinion

    Favourable Opinion