A Parallel-group Treatment, Phase 3, Double-blind, Randomized, 2-arm Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)
VectivBio AG
Summary
This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.
Description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to investigate the efficacy, safety, and tolerability of apraglutide compared with placebo in adults with SBS-IF. The study population will be representative of the SBS-IF general population and will include adult participants (≥18 years of age) who are dependent on, and who are receiving, PS at least 3 days per week. Eligible participants will be randomized 1:1 to receive SC apraglutide or placebo once weekly for 24 weeks stratified by anatomy (i.e., colon-in-continuity \[CIC\] or stoma) and bas…