Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Short Bowel Syndrome Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905707
• Other study ID #: ZP1848-17127
• Status: Recruiting
• Phase: Phase 3
• Start date: May 7, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Zealand Pharma
• Contact: Medical Director
• Phone: +4588773600
• Email: lbg[@]zealandpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Bruxelles
Belgium	UZ Leuven	Leuven
Canada	The Royal Alexandra Hospital	Edmonton
Canada	Western University	London
Canada	University Health Network - Toronto General Hospital	Toronto
Denmark	Rigshospitalet	Copenhagen
France	Hôpital Beaujon	Clichy
France	CHRU de Lille	Lille
France	CHRU Nancy	Nancy
France	Hôpital de l'Archet	Nice
France	Centre Hospitalier Lyon-Sud	Pierre-Bénite
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Frankfurt - Med. Klinik I	Frankfurt
Germany	Asklepios Kliniken Hamburg GmbH	Hamburg
Germany	Universitätsmedizin Rostock	Rostock
Germany	Universitätsklinikum Tübingen - Innere Medizin I	Tübingen
Italy	Azienda Ospedaliero-Universitaria	Bologna
Italy	Azienda Ospedaliero Universitaria Federico II	Napoli
Netherlands	UMC Radboud Nijmegen	Nijmegen
Poland	Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi	Lódz
Poland	Solumed	Poznan
Poland	Szpital Skawina sp. z o.o. im. Stanley Dudricka	Skawina
United Kingdom	St Mark's Hospital	Harrow
United Kingdom	UCLH Foundation NHS Trust	London
United Kingdom	Salford Royal NHS Foundation Trust	Manchester
United Kingdom	University of East Anglia	Norwich
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United States	Division of Gastroenterology and Hepatology	Chicago	Illinois
United States	University of Chicago Children's Hospital	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Miami Transplant Institute	Miami	Florida
United States	Vanderbilt University Medical Center, Nashville	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Mayo Clinic College of Medicine	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Zealand Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Adverse Events	Incidence and type of Adverse Events	2 years
Secondary	Safety - Serious Adverse Events	Incidence and type of Serious Adverse Events	2 years
Secondary	Safety - Adverse Events of Special Interest	Incidence and type of Adverse Events of Special Interest	2 years
Secondary	Safety - Changes in blood pressure from baseline	Changes in systolic and diastolic blood pressure will be reported	2 years
Secondary	Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)	Number of patients with clinically significant changes in ECG will be reported	2 years
Secondary	Immunogenicity - Occurrence of anti-drug antibodies	Occurrence of antibodies against glepaglutide	2 years
Secondary	Change in weekly Parenteral Support (PS) volume	Change in weekly PS volume from baseline	2 years
Secondary	Number of patients with 20 percent reduction in PS volume	Achieving at least 20 percent reduction in weekly PS volume from baseline	2 years
Secondary	Days off PS	Achieving 1 or more days per week off PS	2 years
Secondary	Weaned off PS	Reduction in weekly PS volume of 100 percent (weaned off)	2 years
Secondary	Changes in fluid composite effect	Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline	2 years
Secondary	Energy content (lipids)	Change in lipids content (in kcal/L or kjoule/L) of PS from baseline	2 years
Secondary	Energy content (glucose)	Change in glucose content (in kcal/L or kjoule/L) of PS from baseline	2 years
Secondary	Energy content (amino acids)	Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline	2 years
Secondary	Days on PS	Change in number of days on PS per week from baseline	2 years
Secondary	Number of patients with 40 percent change in PS volume per week	Achieving 40 percent in PS volume from baseline	2 years