Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
Purpose
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
Condition
- Short Bowel Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed informed consent for this trial prior to any trial specific assessment. 2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC). 3. Subject must require PS at least 3 days per work and be considered stable. 4. No restorative surgery intended to change PS requirements in the trial period. 5. Age ≥18 years at screening.
Exclusion Criteria
- Pregnancy or lactation. 2. Major abdominal surgery in the last 6 months prior to screening. 3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer. 4. Evidence of active inflammatory GI conditions in the previous 6 months. 5. Evidence of decompensated heart failure. 6. Evidence of severe renal or hepatic impairment. 7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Apraglutide SC injections, once weekly |
Peptide analogue of GLP-2 |
|
Placebo Comparator Placebo |
Placebo for apraglutide, SC injection once weekly |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- VectivBio AG
Study Contact
Detailed Description
This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue. The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.