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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS (EASE SBS 1)

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ClinicalTrials.gov Identifier: NCT03690206
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Tracking Information
First Submitted Date  ICMJE September 17, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date September 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Change in weekly Parenteral Support (PS) volume [ Time Frame: 24 weeks ]
Change in weekly PS volume from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Clinical response in Parenteral Support (PS) volume [ Time Frame: 20 and 24 weeks ]
Achieving at least 20 percent reduction in weekly PS volume from baseline
Change History Complete list of historical versions of study NCT03690206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Clinical response in PS volume [ Time Frame: 20 and 24 weeks ]
    Achieving at least 20 percent reduction in weekly PS volume from baseline
  • Days off PS [ Time Frame: 24 weeks ]
    Achieving 1 or more days per week off PS
  • Clinical response in PS volume [ Time Frame: 12 and 24 weeks ]
    Reduction of at least 20 percent in PS volume from baseline
  • Weaned off PS [ Time Frame: 24 weeks ]
    Reduction in weekly PS volume of 100 percent (weaned off)
  • Fluid composite effect [ Time Frame: 24 weeks ]
    Change in fluid composite effect from baseline
  • Energy content [ Time Frame: 24 weeks ]
    Change in energy content of PS from baseline
  • Days on PS [ Time Frame: 24 weeks ]
    Change in number of days on PS per week from baseline
  • Change in PS volume per week [ Time Frame: 20 and 24 weeks ]
    Achieving 40 percent in PS volume from baseline
  • Patient Global Impression of Change scale (PGIC) [ Time Frame: 24 weeks ]
    Change PGIC
  • Safety - Adverse Events [ Time Frame: 28 weeks ]
    Incidence and type of Adverse Events
  • Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG) [ Time Frame: 28 weeks ]
    Number of patients with clinically significant changes in ECG will be reported
  • Safety - Changes in blood pressure from baseline [ Time Frame: 28 weeks ]
    Changes in blood pressure will be reported
  • Safety - Changes in body temperature from baseline [ Time Frame: 28 weeks ]
    Changes in body temperature will be reported
  • Immunogenicity - Occurrence of anti-drug antibodies [ Time Frame: 28 weeks ]
    Occurrence of antibodies against glepaglutide
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Change in weekly PS volume [ Time Frame: 24 weeks ]
    Change in weekly PS volume from baseline
  • Days off PS [ Time Frame: 24 weeks ]
    Achieving 1 or more days per week off PS
  • Clinical response in PS volume [ Time Frame: 12 and 24 weeks ]
    Reduction of at least 20 percent in PS volume from baseline
  • Weaned off PS [ Time Frame: 24 weeks ]
    Reduction in weekly PS volume of 100 percent (weaned off)
  • Fluid composite effect [ Time Frame: 24 weeks ]
    Change in fluid composite effect from baseline
  • Energy content [ Time Frame: 24 weeks ]
    Change in energy content of PS from baseline
  • Days on PS [ Time Frame: 24 weeks ]
    Change in number of days on PS per week from baseline
  • Change in PS volume per week [ Time Frame: 20 and 24 weeks ]
    Achieving 40 percent in PS volume from baseline
  • Patient Global Impression of Change scale (PGIC) [ Time Frame: 24 weeks ]
    Change PGIC
  • Safety - Adverse Events [ Time Frame: 28 weeks ]
    Incidence and type of Adverse Events
  • Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG) [ Time Frame: 28 weeks ]
    Number of patients with clinically significant changes in ECG will be reported
  • Safety - Changes in blood pressure from baseline [ Time Frame: 28 weeks ]
    Changes in blood pressure will be reported
  • Safety - Changes in body temperature from baseline [ Time Frame: 28 weeks ]
    Changes in body temperature will be reported
  • Immunogenicity - Occurrence of anti-drug antibodies [ Time Frame: 28 weeks ]
    Occurrence of antibodies against glepaglutide
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Official Title  ICMJE A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)
Brief Summary

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Detailed Description A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Short Bowel Syndrome
Intervention  ICMJE
  • Drug: glepaglutide
    Glucagon-Like Peptide-2 (GLP-2) analog
    Other Name: ZP1848
  • Drug: Placebo
    Placebo for glepaglutide
Study Arms  ICMJE
  • Experimental: Glepaglutide SC injections twice weekly
    Intervention: Glepaglutide
    Intervention: Drug: glepaglutide
  • Experimental: Glepaglutide SC injections once weekly and placebo once weekly
    Intervention: Glepaglutide
    Intervention: Drug: glepaglutide
  • Placebo Comparator: Placebo SC injections twice weekly
    Intervention: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
129
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2020
Estimated Primary Completion Date September 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent obtained before any trial-related activity.
  • Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.
  • Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.
  • In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.

Exclusion Criteria:

  • More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.
  • Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
  • Bowel obstruction.
  • Known radiation enteritis or significant villous atrophy.
  • Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening.
  • Clinically significant abnormal ECG.
  • Repeated systolic blood pressure measurements > 180 mm Hg.
  • Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.
  • Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
  • Estimated creatinine clearance < 30 mL/min.
  • Severe hepatic impairment.
  • Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.
  • Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
  • Unstable systemic immunosuppressive therapy within 3 months prior to Screening.
  • Unstable biological therapy within 6 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.
  • Previous exposure to glepaglutide.
  • Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Senior Clinical Trial Manager +45 88 77 36 00 cll@zealandpharma.com
Contact: Clinical Trial Manager +45 88 77 36 00 teg@zealandpharma.com
Listed Location Countries  ICMJE Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03690206
Other Study ID Numbers  ICMJE ZP1848-17111
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zealand Pharma
Study Sponsor  ICMJE Zealand Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Zealand Pharma
PRS Account Zealand Pharma
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP