EASE SBS1 Efficacy And Safety Evaluation of Glepaglutide in SBS
Research type
Research Study
Full title
A PHASE 3, INTERNATIONAL, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF GLEPAGLUTIDE IN PATIENTS WITH SHORT BOWEL SYNDROME (SBS)
IRAS ID
249125
Contact name
Farooq Rahman
Contact email
Sponsor organisation
Zealand Pharma A/S
Eudract number
2017-004394-14
Clinicaltrials.gov Identifier
133151, IND
Duration of Study in the UK
1 years, 10 months, 14 days
Research summary
Research Summary
This study will aim to demonstrate the superiority of once weekly and twice weekly subcutaneous (SC) injections of 10 mg glepaglutide versus placebo in stable patients with short bowel syndrome(SBS). Glepaglutide improves the intestinal function and reduces the need for parenteral support (PS), which improves patients' health status and quality of life.
This study will be performed at NHS hospital sites in England and patients with SBS between the ages of 18 and 90 will potentially be eligible.After providing consent, SBS patients will be screened for eligibility and a drinking menu will be defined (1 week). During screening patients may have to undergo a colonoscopy, CT scan or MRI, dependent on whether their remnant colon is dormant or not. Patients then enter an optimization period(during which the Parenteral Support (PS) might be changed) and followed by a stabilization period (during which stability criteria will be evaluated). This may take between 4 and 8 weeks. Patients are issued with and electronic diary (eDiary)after screening to enter trial data/information.
Baseline measurements are performed prior to dosing on Day 1. All eligible patients will be randomized in a 1:1:1 manner to receive either: a) glepaglutide 10 mg twice weekly, b) glepaglutide 10 mg once weekly and placebo once weekly, or c) placebo SC for the following 24 weeks.
The dosing period will take place over the following 24 weeks during which patients will visit the hospital at least 9 times and receive one phone call on Day 3, administer the drug subcutaneously, measure their urine output (once-monthly 48hr periods), complete e-diaries and provide blood samples during site visits for safety tests.
Questionnaires will be completed at site visits to provide feedback on the impact of glepaglutide on their lives and health.
Exit interviews will be conducted with patients following the End-of-Trial visit, ≤ 7 days from the last visit.Lay summary of study results
The results will soon be verified and published.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0330
Date of REC Opinion
7 Dec 2018
REC opinion
Further Information Favourable Opinion