A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Zealand Pharma
- Enrollment
- 28
- Locations
- 16
- Primary Endpoint
- Number of treatment emergent adverse events (TEAEs)
Study Overview
Brief Summary
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Detailed Description
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has provided signed informed consent and agrees to comply with protocol requirements.
- •Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or
- •Actively treated in the EASE SBS 3 trial.
Exclusion Criteria
- •Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial.
- •Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
- •Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial.
- •Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.)
- •If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception.
- •Has a known or suspected hypersensitivity to glepaglutide or related products.
- •Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.
- •Is an employee of the sponsor or investigator or otherwise dependent on them.
Arms & Interventions
Open-label Glepaglutide
Intervention: Glepaglutide 10 mg (Drug)
Outcomes
Primary Outcomes
Number of treatment emergent adverse events (TEAEs)
Time Frame: From baseline to the safety follow-up visit (A maximum of 25 months)
Secondary Outcomes
- Change in prescribed weekly parenteral support (PS) volume(From baseline to Month 24 (End of Trial))