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

Sponsor
Zealand Pharma (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04881825
Collaborator
(none)
129
Enrollment
12
Locations
1
Arm
45.5
Anticipated Duration (Months)
10.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
129 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 16, 2021
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: once-weekly glepaglutide

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

Drug: Glepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
Other Names:
  • ZP1848

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and type of Adverse Events (AEs) [After 108 weeks]

      For AEs with onset or worsening following Visit 1

    Secondary Outcome Measures

    1. Incidence and type of Serious Adverse Events (SAEs) [After 108 weeks]

      For AEs with onset or worsening following Visit 1

    2. Incidence and type of Adverse Events of Special Interest (AESIs) [After 108 weeks]

      For AEs with onset or worsening following Visit 1

    3. Change in body temperature [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    4. Change in heart rate [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    5. Change in blood pressure [Week 0 in lead-in trial (EASE SBS 1), Week 108]

      Seated diastolic and systolic blood pressure

    6. Change in body weight [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    7. Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG) [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    8. Change in hematology - hemoglobin [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    9. Change in hematology - hematocrit [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    10. Change in hematology - white blood cell count [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    11. Change in hematology - platelet count [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    12. Change in biochemistry - sodium [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    13. Change in biochemistry - potassium [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    14. Change in biochemistry - chloride [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    15. Change in biochemistry - bicarbonate [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    16. Change in biochemistry - blood urea nitrogen [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    17. Change in biochemistry - creatinine [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    18. Change in biochemistry - creatinine clearance [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    19. Change in biochemistry - glucose [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    20. Change in biochemistry - calcium [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    21. Change in biochemistry - phosphorous [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    22. Change in biochemistry - alkaline phosphatase [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    23. Change in biochemistry - alanine aminotransferase (ALT) [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    24. Change in biochemistry - aspartate aminotransferase (AST) [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    25. Change in biochemistry - International Normalized Ratio (INR) [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    26. Change in biochemistry - gamma-glutamyl transferase (GGT) [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    27. Change in biochemistry - lactic dehydrogenase [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    28. Change in biochemistry - conjugated bilirubin [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    29. Change in biochemistry - total bilirubin [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    30. Change in biochemistry - total protein [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    31. Change in biochemistry - albumin [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    32. Change in biochemistry - amylase [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    33. Change in biochemistry - uric acid [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    34. Change in biochemistry - C-reactive protein [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    35. Change in urinalysis - blood [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    36. Change in urinalysis - glucose [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    37. Change in urinalysis - leukocytes [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    38. Change in urinalysis - pH [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    39. Change in urinalysis - osmolality [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    40. Change in urinalysis - protein [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    41. Change in urinalysis - sodium [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    42. Change in urinalysis - potassium [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    43. Anti-glepaglutide antibodies [Week 0, Week 108]

    44. Antibody reactivity to ZP1848 [Week 0, Week 108]

    45. Cross-reactivity to glucagon-like peptide-2 (GLP-2) [Week 0, Week 108]

    46. Glepaglutide neutralizing antibodies [Week 0, Week 108]

    47. Reduction in weekly Parenteral Support (PS) volume [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    48. Reduction of at least 20 percent in weekly PS volume [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    49. Reduction in days on PS greater than or equal to 1 day per week [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    50. Reduction in weekly PS volume of 100 percent (weaned off) [Week 0 in lead-in trial (EASE SBS 1), Week 108]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Nebraska Medical Center Omaha Nebraska United States 68198
    2 Universitair Ziekenhuis Leuven Leuven Belgium
    3 Rigshospitalet Copenhagen Denmark
    4 Hôpital Beaujon Clichy France
    5 Centre Hospitalier Lyon-Sud Pierre-Bénite France
    6 Charité - Universitätsmedizin Berlin Berlin Germany
    7 Asklepios Kliniken Hamburg GmbH Hamburg Germany
    8 UMC Radboud Nijmegen Nijmegen Netherlands
    9 Solumed Poznań Poland
    10 Szpital Skawina sp. z o.o. im. Stanley Dudricka Skawina Poland
    11 Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi Łódź Poland
    12 UCLH Foundation NHS Trust London United Kingdom

    Sponsors and Collaborators

    • Zealand Pharma

    Investigators

    • Study Director: Zealand Pharma, Zealand Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zealand Pharma
    ClinicalTrials.gov Identifier:
    NCT04881825
    Other Study ID Numbers:
    • ZP1848-20110
    • 2020-005502-25
    • U1111-1261-3358
    First Posted:
    May 11, 2021
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Short Bowel Syndrome
    Syndrome

    Study Results

    No Results Posted as of Mar 8, 2022