Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS (EASE SBS 2)
Primary Purpose
Short Bowel Syndrome
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
glepaglutide
Sponsored by
About this trial
This is an interventional treatment trial for Short Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activity
- Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)
Exclusion Criteria:
- Withdrawal of consent from the lead-in trial
- Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results
- Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening
- Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods
Sites / Locations
- Mayo Clinic
- Georgetown University Medical CenterRecruiting
- Miami Transplant Institute
- Division of Gastroenterology and Hepatology
- University of Chicago Children's HospitalRecruiting
- University of Louisville
- Mayo Clinic College of MedicineRecruiting
- University of Nebraska Medical CenterRecruiting
- Mount Sinai HospitalRecruiting
- Cleveland ClinicRecruiting
- Vanderbilt University Medical Center, NashvilleRecruiting
- Houston Methodist Hospital
- Hôpital Erasme
- UZ LeuvenRecruiting
- The Royal Alexandra HospitalRecruiting
- Western UniversityRecruiting
- University Health Network - Toronto General HospitalRecruiting
- RigshospitaletRecruiting
- Hôpital BeaujonRecruiting
- CHRU de Lille
- CHRU Nancy
- Hôpital de l'Archet
- Centre Hospitalier Lyon-SudRecruiting
- Charité - Universitätsmedizin BerlinRecruiting
- Universitätsklinikum BonnRecruiting
- Universitätsklinikum Frankfurt - Med. Klinik IRecruiting
- Asklepios Kliniken Hamburg GmbHRecruiting
- Universitätsmedizin RostockRecruiting
- Universitätsklinikum Tübingen - Innere Medizin I
- Azienda Ospedaliero-Universitaria
- Azienda Ospedaliero Universitaria Federico II
- UMC Radboud NijmegenRecruiting
- SolumedRecruiting
- Szpital Skawina sp. z o.o. im. Stanley DudrickaRecruiting
- Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w LodziRecruiting
- St Mark's HospitalRecruiting
- UCLH Foundation NHS TrustRecruiting
- Salford Royal NHS Foundation Trust
- University of East AngliaRecruiting
- University Hospital Southampton NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glepaglutide SC injections twice weekly
Glepaglutide SC injections once weekly and placebo once weekly
Arm Description
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm.
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly. In this long term safety study, there is no placebo arm.
Outcomes
Primary Outcome Measures
Safety - Adverse Events
Incidence and type of Adverse Events
Secondary Outcome Measures
Safety - Serious Adverse Events
Incidence and type of Serious Adverse Events
Safety - Adverse Events of Special Interest
Incidence and type of Adverse Events of Special Interest
Safety - Changes in blood pressure from baseline
Changes in systolic and diastolic blood pressure will be reported
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)
Number of patients with clinically significant changes in ECG will be reported
Immunogenicity - Occurrence of anti-drug antibodies
Occurrence of antibodies against glepaglutide
Change in weekly Parenteral Support (PS) volume
Change in weekly PS volume from baseline
Number of patients with 20 percent reduction in PS volume
Achieving at least 20 percent reduction in weekly PS volume from baseline
Days off PS
Achieving 1 or more days per week off PS
Weaned off PS
Reduction in weekly PS volume of 100 percent (weaned off)
Changes in fluid composite effect
Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Energy content (lipids)
Change in lipids content (in kcal/L or kjoule/L) of PS from baseline
Energy content (glucose)
Change in glucose content (in kcal/L or kjoule/L) of PS from baseline
Energy content (amino acids)
Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline
Days on PS
Change in number of days on PS per week from baseline
Number of patients with 40 percent change in PS volume per week
Achieving 40 percent in PS volume from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03905707
Brief Title
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
Acronym
EASE SBS 2
Official Title
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (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
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
Detailed Description
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glepaglutide SC injections twice weekly
Arm Type
Experimental
Arm Description
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.
In this long term safety study, there is no placebo arm.
Arm Title
Glepaglutide SC injections once weekly and placebo once weekly
Arm Type
Experimental
Arm Description
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly.
In this long term safety study, there is no placebo arm.
Intervention Type
Drug
Intervention Name(s)
glepaglutide
Other Intervention Name(s)
ZP1848
Intervention Description
Glucagon-Like Peptide-2 (GLP-2) analog
Primary Outcome Measure Information:
Title
Safety - Adverse Events
Description
Incidence and type of Adverse Events
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety - Serious Adverse Events
Description
Incidence and type of Serious Adverse Events
Time Frame
2 years
Title
Safety - Adverse Events of Special Interest
Description
Incidence and type of Adverse Events of Special Interest
Time Frame
2 years
Title
Safety - Changes in blood pressure from baseline
Description
Changes in systolic and diastolic blood pressure will be reported
Time Frame
2 years
Title
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)
Description
Number of patients with clinically significant changes in ECG will be reported
Time Frame
2 years
Title
Immunogenicity - Occurrence of anti-drug antibodies
Description
Occurrence of antibodies against glepaglutide
Time Frame
2 years
Title
Change in weekly Parenteral Support (PS) volume
Description
Change in weekly PS volume from baseline
Time Frame
2 years
Title
Number of patients with 20 percent reduction in PS volume
Description
Achieving at least 20 percent reduction in weekly PS volume from baseline
Time Frame
2 years
Title
Days off PS
Description
Achieving 1 or more days per week off PS
Time Frame
2 years
Title
Weaned off PS
Description
Reduction in weekly PS volume of 100 percent (weaned off)
Time Frame
2 years
Title
Changes in fluid composite effect
Description
Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Time Frame
2 years
Title
Energy content (lipids)
Description
Change in lipids content (in kcal/L or kjoule/L) of PS from baseline
Time Frame
2 years
Title
Energy content (glucose)
Description
Change in glucose content (in kcal/L or kjoule/L) of PS from baseline
Time Frame
2 years
Title
Energy content (amino acids)
Description
Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline
Time Frame
2 years
Title
Days on PS
Description
Change in number of days on PS per week from baseline
Time Frame
2 years
Title
Number of patients with 40 percent change in PS volume per week
Description
Achieving 40 percent in PS volume from baseline
Time Frame
2 years
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 lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)
Exclusion Criteria:
Withdrawal of consent from the lead-in trial
Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results
Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening
Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director
Phone
+4588773600
Email
mag@zealandpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Senior Clinical Trial Manager
Phone
+4588773600
Email
teg@zealandpharma.com
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
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Withdrawn
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Miami Transplant Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Division of Gastroenterology and Hepatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Chicago Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic College of Medicine
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3285
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Vanderbilt University Medical Center, Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
68198-3285
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hôpital Erasme
City
Bruxelles
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
The Royal Alexandra Hospital
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Western University
City
London
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@Zealandpharma.com
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
CHRU de Lille
City
Lille
Country
France
Individual Site Status
Withdrawn
Facility Name
CHRU Nancy
City
Nancy
Country
France
Individual Site Status
Withdrawn
Facility Name
Hôpital de l'Archet
City
Nice
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Universitätsklinikum Frankfurt - Med. Klinik I
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Asklepios Kliniken Hamburg GmbH
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Universitätsmedizin Rostock
City
Rostock
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Universitätsklinikum Tübingen - Innere Medizin I
City
Tübingen
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero-Universitaria
City
Bologna
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero Universitaria Federico II
City
Napoli
Country
Italy
Individual Site Status
Withdrawn
Facility Name
UMC Radboud Nijmegen
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Solumed
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Szpital Skawina sp. z o.o. im. Stanley Dudricka
City
Skawina
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
City
Łódź
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
St Mark's Hospital
City
Harrow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
UCLH Foundation NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
Salford Royal NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
University of East Anglia
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical Director
Email
mag@zealandpharma.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
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