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

Primary Purpose

Short Bowel Syndrome

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glepaglutide
Sponsored by
Zealand Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Georgetown University Medical Center
  • University of Nebraska Medical Center
  • Vanderbilt University Medical Center, Nashville
  • Universitair Ziekenhuis Leuven
  • Rigshospitalet
  • Hôpital Beaujon
  • Centre Hospitalier Lyon-Sud
  • Charité - Universitätsmedizin Berlin
  • Asklepios Kliniken Hamburg GmbH
  • Universitätsmedizin Rostock
  • UMC Radboud Nijmegen
  • Solumed
  • Szpital Skawina sp. z o.o. im. Stanley Dudricka
  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
  • St Mark's Hospital
  • UCLH Foundation NHS Trust
  • Norfolk and Norwich University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

once-weekly glepaglutide

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence and type of Adverse Events (AEs)
For AEs with onset or worsening following Visit 1

Secondary Outcome Measures

Incidence and type of Serious Adverse Events (SAEs)
For AEs with onset or worsening following Visit 1
Incidence and type of Adverse Events of Special Interest (AESIs)
For AEs with onset or worsening following Visit 1
Change in body temperature
Change in heart rate
Change in blood pressure
Seated diastolic and systolic blood pressure
Change in body weight
Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)
Change in hematology - hemoglobin
Change in hematology - hematocrit
Change in hematology - white blood cell count
Change in hematology - platelet count
Change in biochemistry - sodium
Change in biochemistry - potassium
Change in biochemistry - chloride
Change in biochemistry - bicarbonate
Change in biochemistry - blood urea nitrogen
Change in biochemistry - creatinine
Change in biochemistry - creatinine clearance
Change in biochemistry - glucose
Change in biochemistry - calcium
Change in biochemistry - phosphorous
Change in biochemistry - alkaline phosphatase
Change in biochemistry - alanine aminotransferase (ALT)
Change in biochemistry - aspartate aminotransferase (AST)
Change in biochemistry - International Normalized Ratio (INR)
Change in biochemistry - gamma-glutamyl transferase (GGT)
Change in biochemistry - lactic dehydrogenase
Change in biochemistry - conjugated bilirubin
Change in biochemistry - total bilirubin
Change in biochemistry - total protein
Change in biochemistry - albumin
Change in biochemistry - amylase
Change in biochemistry - uric acid
Change in biochemistry - C-reactive protein
Change in urinalysis - blood
Change in urinalysis - glucose
Change in urinalysis - leukocytes
Change in urinalysis - pH
Change in urinalysis - osmolality
Change in urinalysis - protein
Change in urinalysis - sodium
Change in urinalysis - potassium
Anti-glepaglutide antibodies
Antibody reactivity to ZP1848
Cross-reactivity to glucagon-like peptide-2 (GLP-2)
Glepaglutide neutralizing antibodies
Reduction in weekly Parenteral Support (PS) volume
Reduction of at least 20 percent in weekly PS volume
Reduction in days on PS greater than or equal to 1 day per week
Reduction in weekly PS volume of 100 percent (weaned off)

Full Information

First Posted
April 22, 2021
Last Updated
August 2, 2023
Sponsor
Zealand Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04881825
Brief Title
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
Acronym
EASE SBS 3
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
once-weekly glepaglutide
Arm Type
Experimental
Arm Description
All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
Intervention Type
Drug
Intervention Name(s)
Glepaglutide
Other Intervention Name(s)
ZP1848
Intervention Description
Glepaglutide will be delivered in a single-use autoinjector.
Primary Outcome Measure Information:
Title
Incidence and type of Adverse Events (AEs)
Description
For AEs with onset or worsening following Visit 1
Time Frame
After 108 weeks
Secondary Outcome Measure Information:
Title
Incidence and type of Serious Adverse Events (SAEs)
Description
For AEs with onset or worsening following Visit 1
Time Frame
After 108 weeks
Title
Incidence and type of Adverse Events of Special Interest (AESIs)
Description
For AEs with onset or worsening following Visit 1
Time Frame
After 108 weeks
Title
Change in body temperature
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in heart rate
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in blood pressure
Description
Seated diastolic and systolic blood pressure
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in body weight
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in hematology - hemoglobin
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in hematology - hematocrit
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in hematology - white blood cell count
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in hematology - platelet count
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - sodium
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - potassium
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - chloride
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - bicarbonate
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - blood urea nitrogen
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - creatinine
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - creatinine clearance
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - glucose
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - calcium
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - phosphorous
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - alkaline phosphatase
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - alanine aminotransferase (ALT)
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - aspartate aminotransferase (AST)
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - International Normalized Ratio (INR)
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - gamma-glutamyl transferase (GGT)
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - lactic dehydrogenase
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - conjugated bilirubin
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - total bilirubin
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - total protein
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - albumin
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - amylase
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - uric acid
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in biochemistry - C-reactive protein
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - blood
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - glucose
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - leukocytes
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - pH
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - osmolality
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - protein
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - sodium
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Change in urinalysis - potassium
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Anti-glepaglutide antibodies
Time Frame
Week 0, Week 108
Title
Antibody reactivity to ZP1848
Time Frame
Week 0, Week 108
Title
Cross-reactivity to glucagon-like peptide-2 (GLP-2)
Time Frame
Week 0, Week 108
Title
Glepaglutide neutralizing antibodies
Time Frame
Week 0, Week 108
Title
Reduction in weekly Parenteral Support (PS) volume
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Reduction of at least 20 percent in weekly PS volume
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Reduction in days on PS greater than or equal to 1 day per week
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108
Title
Reduction in weekly PS volume of 100 percent (weaned off)
Time Frame
Week 0 in lead-in trial (EASE SBS 1), Week 108

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zealand Pharma
Organizational Affiliation
Zealand Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Vanderbilt University Medical Center, Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
68198-3285
Country
United States
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Asklepios Kliniken Hamburg GmbH
City
Hamburg
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
Country
Germany
Facility Name
UMC Radboud Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Solumed
City
Poznań
Country
Poland
Facility Name
Szpital Skawina sp. z o.o. im. Stanley Dudricka
City
Skawina
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
City
Łódź
Country
Poland
Facility Name
St Mark's Hospital
City
Harrow
Country
United Kingdom
Facility Name
UCLH Foundation NHS Trust
City
London
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

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