ong-Term, Extension Trial Investigating the Safety and Efficacy of glepaglutide in patients with short bowel syndrome

Phase 1

• Conditions: Short bowel syndrome; MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-005502-25-DK
• Lead Sponsor: Zealand Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

The patient must meet both of the following inclusion criteria:
1. Signed informed consent
2. Completed the full treatment period of the extension trial EASE SBS 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

The patient must be excluded from this trial if any of the following criteria are met:
1. 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.
2. Not having a colonoscopy performed at EOT 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 EOT 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.
3. 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.
4. Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods.
5. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
6. An employee of the sponsor or Investigator or otherwise dependent on them.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective:<br>• To evaluate the long-term safety of glepaglutide treatment in adult patients with SBS.<br>;Secondary Objective: Secondary Objectives:<br>• To evaluate the maintenance of response with regards to efficacy endpoints with glepaglutide 10 mg once weekly (OW)<br>• To assess the long-term immunogenicity of glepaglutide and its impact on pharmacokinetics (PK), safety, and efficacy maintenance;Primary end point(s): The primary endpoint is the incidence and type of AEs, with onset or worsening following Visit 1 and will be presented by system organ class (SOC) and preferred term (PT) in total and by treatment sequence prior to the EASE SBS 3 trial.;Timepoint(s) of evaluation of this end point: As described under point E 5.1.: With onset or worsening following Visit 1