A 104-Week, Multicenter, Single-Arm, Long-Term, 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
- Conditions
- Short Bowel Syndrome10025477
- Registration Number
- NL-OMON50675
- Lead Sponsor
- Zealand Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For all patients, changes from baseline are relative to the baseline assessment<br /><br>in the lead-in trial, EASE SBS 1, if not otherwise specified.<br /><br><br /><br>Safety Endpoints:<br /><br><br /><br>Primary Endpoint:<br /><br>Incidence and type of adverse events (AEs), with onset or worsening following<br /><br>Visit 1</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety Endpoints:<br /><br><br /><br>Secondary Endpoints:<br /><br>• Incidence and type of serious adverse events (SAEs) and AEs of special<br /><br>interest (AESIs) (with onset or worsening following Visit 1)<br /><br>• Changes from baseline in:<br /><br>- Vital signs<br /><br>- Electrocardiogram<br /><br>• Changes from baseline in:<br /><br>- Hematology<br /><br>- Biochemistry<br /><br>- Urinalysis<br /><br>• Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to<br /><br>ZP18481-34, -cross reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide<br /><br>neutralizing antibodies)<br /><br><br /><br>Efficacy Endpoints:<br /><br><br /><br>The secondary efficacy endpoints are:<br /><br>• Reduction in weekly PS volume (prescribed) from baseline<br /><br>• Reduction of at least 20% in weekly PS volume (prescribed) from baseline<br /><br>• Reduction in days on PS >= 1 day/week from baseline<br /><br>• Reduction in weekly PS volume of 100% (weaned off)</p><br>