Clinical trial NCT04881825: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Short Bowel Syndrome
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence and type of Adverse Events (AEs)
timeFrame: After 108 weeks
Secondary outcomes:
measure: Incidence and type of Serious Adverse Events (SAEs)
timeFrame: After 108 weeks
measure: Incidence and type of Adverse Events of Special Interest (AESIs)
timeFrame: After 108 weeks
measure: Change in body temperature
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in heart rate
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in blood pressure
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in body weight
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in hematology - hemoglobin
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in hematology - hematocrit
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in hematology - white blood cell count
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in hematology - platelet count
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - sodium
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - potassium
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - chloride
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - bicarbonate
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - blood urea nitrogen
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - creatinine
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - creatinine clearance
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - glucose
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - calcium
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - phosphorous
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - alkaline phosphatase
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - alanine aminotransferase (ALT)
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - aspartate aminotransferase (AST)
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - International Normalized Ratio (INR)
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - gamma-glutamyl transferase (GGT)
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - lactic dehydrogenase
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - conjugated bilirubin
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - total bilirubin
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - total protein
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - albumin
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - amylase
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - uric acid
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in biochemistry - C-reactive protein
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - blood
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - glucose
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - leukocytes
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - pH
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - osmolality
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - protein
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - sodium
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Change in urinalysis - potassium
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Anti-glepaglutide antibodies
timeFrame: Week 0, Week 108
measure: Antibody reactivity to ZP1848
timeFrame: Week 0, Week 108
measure: Cross-reactivity to glucagon-like peptide-2 (GLP-2)
timeFrame: Week 0, Week 108
measure: Glepaglutide neutralizing antibodies
timeFrame: Week 0, Week 108
measure: Reduction in weekly Parenteral Support (PS) volume
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Reduction of at least 20 percent in weekly PS volume
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Reduction in days on PS greater than or equal to 1 day per week
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
measure: Reduction in weekly PS volume of 100 percent (weaned off)
timeFrame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Rochester
country: United States
facility: Mayo Clinic College of Medicin
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Nashville
state: Tennessee
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Clichy
country: France
facility: Hôpital Beaujon
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Nijmegen
country: Netherlands
facility: UMC Radboud Nijmegen
city: Skawina
country: Poland
facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka
city: Łódź
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
city: London
country: United Kingdom
facility: UCLH Foundation NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals
Study officials:
affiliation: Zealand Pharma
name: Zealand Pharma
role: STUDY_DIRECTOR
References: