Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial (EASE SBS 3)

Zealand Pharma

Status and phase: Active, not recruiting; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Drug: Glepaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04881825

U1111-1261-3358 (Other Identifier)

ZP1848-20110

2020-005502-25 (EudraCT Number)

Details and patient eligibility

About

This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

Enrollment: 129 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activity
• Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)

Exclusion criteria

• Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial
• Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator
• Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed
• Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

once-weekly glepaglutide

Experimental group

Description:

All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Treatment:

Drug: Glepaglutide