EASE SBS 3 - Evaluation of Glepaglutide in Treatment of SBS
Research type
Research Study
Full title
A 104-WEEK, MULTICENTER, SINGLE-ARM, LONGTERM,PHASE 3 EXTENSION TRIAL INVESTIGATING THE SAFETY AND EFFICACY OF GLEPAGLUTIDE IN ADULT PATIENTS WITH SHORT BOWEL SYNDROME (SBS) COMPLETING THE EASE SBS 2 TRIAL
IRAS ID
301398
Contact name
Farooq Rahman
Contact email
Sponsor organisation
Zealand Pharma A/S
Eudract number
2020-005502-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
WHO Universal Trial Number (UTN), U1111-1261-3358; IND, 133151
Duration of Study in the UK
2 years, 11 months, 1 days
Research summary
The purpose of this study is to see how well tolerated long-term use of the study drug (glepaglutide) is in patients with Short Bowel Syndrome and to assess the maintenance of the study drug effect and need for parenteral support (PS) after participating in 2 prior studies with glepaglutide.
Participants of the current EASE SBS 2 study will be able to continue in this EASE SBS 3 study and receive glepaglutide 10 mg once weekly subcutaneously by single-use auto-injector, in addition to standard of care, in this extension trial. It is an open-label trial.Between 100 and 145 patients are anticipated to be enrolled in the study, but this will depend on the exact number of participants completing the EASE SBS 2 trial. The period of treatment is 104 weeks and one follow-up visit is conducted approximately 4 weeks after the last dose of glepaglutide.
The last visit of the EASE SBS 2 trial is also the first visit of this trial. Participants are required to attend a total of 11 visits at the clinic and to receive 3 phone calls during the study. Scheduled clinic visits are about 3 months apart.
Information on medical history and demographics, as well as PS regimen will be recorded. Blood sampling for safety labs will be collected at all scheduled clinic visits. Blood will also be sampled for glepaglutide antibodies, citrulline (marker of intestinal function and to see how the study drug moves through the body (PK) during visits at Day 1, W4 and Month 3, 6 12, 18, 24 & Follow-Up.
An ECG is required at 5 occasions on the study and a colonoscopy twice. Participants who have a remnant colon not connected to the passage of food, may need to undergo a CT scan or MRI to document the absence of concern regarding malignancy.
REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0637
Date of REC Opinion
20 Oct 2021
REC opinion
Further Information Favourable Opinion