EASE SBS 3 (Evaluation of the efficacy and safety of Glepaglutide in the treatment of short bowel syndrome (SBS)
EU CTIS ID: 2024-513373-43-00
What this study is testing
To evaluate the long-term safety of glepaglutide treatment
- 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
- Signed informed consent
- Completed the full treatment period of the extension trial EASE SBS 2.
You likely can't join if
- 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 EOT 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 EOT 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. Please refer to Section 11.4.4. for the definition of highly effective contraception.
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- An employee of the sponsor or Investigator or otherwise dependent on them.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States. 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.