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EASE SBS 2 (Evaluation of the efficacy and safety of Glepaglutide in the treatment of short bowel syndrome) (SBS)
EU CTIS ID: 2024-513374-22-00
What this study is testing
To evaluate the long-term safety of glepaglutide treatment in short bowel syndrome (SBS) patients
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients rolling over from the lead-in trial: Signed informed consent
- Patients rolling over from the lead-in trial: A) Completed the full Treatment Phase of the lead-in trial (ZP1848-17111), regardless of treatment adherence OR B) Eligible based on the same inclusion/exclusion criteria as in the lead-in trial (patients may be directly screened into this trial)
You likely can't join if
- Patients rolling over from the lead-in trial: Withdrew consent from lead-in trial.
- Patients screened directly to the Extension Trial: Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease.
- Patients screened directly to the Extension Trial: Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and.
- Patients screened directly to the Extension Trial: Clinically significant abnormal ECG as judged by the Investigator.
- Patients screened directly to the Extension Trial: Repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure measurements > 180 mm Hg.
- Patients screened directly to the Extension Trial: Human immunodeficiency virus (HIV) positive, acute liver disease, or unstable chronic liver disease.
See the full eligibility criteria
Who can join
- Patients rolling over from the lead-in trial: Signed informed consent
- Patients rolling over from the lead-in trial: A) Completed the full Treatment Phase of the lead-in trial (ZP1848-17111), regardless of treatment adherence OR B) Eligible based on the same inclusion/exclusion criteria as in the lead-in trial (patients may be directly screened into this trial)
What rules you out
- Patients rolling over from the lead-in trial: Withdrew consent from lead-in trial.
- Patients screened directly to the Extension Trial: Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease.
- Patients screened directly to the Extension Trial: Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and.
- Patients screened directly to the Extension Trial: Clinically significant abnormal ECG as judged by the Investigator.
- Patients screened directly to the Extension Trial: Repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure measurements > 180 mm Hg.
- Patients screened directly to the Extension Trial: Human immunodeficiency virus (HIV) positive, acute liver disease, or unstable chronic liver disease.
- Patients screened directly to the Extension Trial: Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years.
- Patients screened directly to the Extension Trial: Estimated creatinine clearance (CrCL; by the Cockcroft-Gault formula) < 30 mL/min.
- Patients screened directly to the Extension Trial: Hepatic impairment defined as: a. Total bilirubin ≥ 2 × the upper limit of normal (ULN), or b. Aspartate aminotransferase (AST) ≥ 5 × ULN, or c. Alanine aminotransferase (ALT) ≥ 5× ULN
- Patients screened directly to the Extension Trial: Use of GLP-1, GLP-2, HGH, somatostatin, or analogs thereof, within 3 months prior to Screening.
- Patients screened directly to the Extension Trial: Use of DPP-4 inhibitors within 3 months prior to Screening.
- Patients rolling over from the lead-in trial: 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 confounds planned assessments of the trial.
- Patients screened directly to the Extension Trial: Systemic immunosuppressive therapy that has been introduced or has been unstable within 3 months prior to Screening.
- Patients screened directly to the Extension Trial: Unstable biological therapy (e.g. anti-tumor necrosis factor alpha [TNF-α], natalizumab, etc.) within 6 months prior to Screening, including significant changes in doses or switch of drug.
- Patients screened directly to the Extension Trial: Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. Highly effective contraception methods and definition of child-bearing potential are described in Section 11.4.4.
- Patients screened directly to the Extension Trial: Known or suspected hypersensitivity to glepaglutide or related products.
- Patients screened directly to the Extension Trial: Previous exposure to glepaglutide.
- Patients screened directly to the Extension Trial: Previous participation (randomization) in this trial.
- Patients screened directly to the Extension Trial: Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
- Patients screened directly to the Extension Trial: Mental incapacity or language barriers which preclude adequate understanding or cooperation, or unwillingness to comply with trial requirements.
- Patients screened directly to the Extension 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.
- Patients screened directly to the Extension Trial: Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- Patients rolling over from the lead-in trial: Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, citrulline, somatostatin, or analogs thereof within 3 months. Note: Prior glepaglutide trial drug is allowed.
- Patients screened directly to the Extension Trial: An employee of the Sponsor or Investigator or otherwise dependent on them.
- Patients rolling over from the lead-in trial: Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Highly effective contraception methods and definition of child-bearing potential are described in Section 11.4.4.
- Patients rolling over from the lead-in trial: Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- Patients rolling over from the lead-in trial: An employee of the sponsor or Investigator or otherwise dependent on them.
- Patients screened directly to the Extension Trial: More than More than 2 SBS-related or PS-related hospitalizations (e.g., catheter related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to Screening.
- Patients screened directly to the Extension Trial: Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
- Patients screened directly to the Extension Trial: Bowel obstruction.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.