Short bowel syndrome MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Glepaglutide
Product Code: ZP1848
Pharmaceutical Form: Solution for injection in pre-filled injector
INN or Proposed INN: GLEPAGLUTIDE
CAS Number: 914009-86-2
Current Sponsor code: ZP184
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: • To evaluate the long-term safety of glepaglutide treatment in adult patients with SBS. ;Secondary Objective: Secondary Objectives: • To evaluate the maintenance of response with regards to efficacy endpoints with glepaglutide 10 mg once weekly (OW) • 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary safety endpoints will be summarized descriptively: • Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) with onset or worsening following Visit 1 • Changes from baseline in: o Vital signs o ECG • Changes from baseline in: o Hematology o Biochemistry o Urinalysis • Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, cross-reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies) The secondary efficacy endpoints are: • Reduction in weekly PS volume (prescribed) from baseline • Reduction of at least 20% in weekly PS volume (prescribed) from baseline • Reduction in days on PS = 1 day/week from baseline • Reduction in weekly PS volume of 100% (weaned off);Timepoint(s) of evaluation of this end point: As specified under point E.5.2. Changes from baseline in this extension trial will be relative to the baseline assessment in the lead-in trial, EASE SBS 1, independent of receiving active or placebo treatment for the first 6 months. | — |
Countries
Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom, United States
Contacts
Public ContactEbru Ucar Kaarup Trial Manager
Zealand Pharma A/S
Outcome results
None listed