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NCT04627025 (Apraglutide in Short Bowel Syndrome with Intestinal Failure): BVCT ex-ante prediction vs. reported outcome

On 5 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 29 Feb 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant; once-weekly apraglutide commercially sufficient non-inferior to once-daily teduglutide.

Clinical Trial

NCTID
NCT04627025
Acronym
STARS
Drug Name
Apraglutide
Drug MoA
GLP2R agonist
Drug Modality
peptide drug
Drug Class
Best-In-Class
Therapeutic Area
Digestive System Diseases
Indication
Short Bowel Syndrome with Intestinal Failure (SBS-IF)
Human Patients
164
Sponsor
Ironwood Pharmaceuticals
Phase
Phase 3

Prediction of , index 463

Prospective Prediction
Prediction Index
463
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
55 days in advance
Readout Data Interpretation
13% placebo-adjusted actual weekly PS volume change (p=0.001) & at least 1 day/week (p=0.04) at week 24 vs 17% actual weekly PS volume change (p<0.001) for once-daily teduglutide; effective for stoma population but not effective for colon-in-continuity population with less intestine resection.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant; once-weekly apraglutide commercially sufficient non-inferior to once-daily teduglutide
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)
Phase
Phase 3
Status
Completed
Enrollment
164
Lead sponsor
VectivBio AG
Conditions
Short Bowel Syndrome
Interventions
DRUG: apraglutide
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-01-26
Primary completion
2024-01-02
Completion
2024-02-22
Primary outcomes
  • Relative change from baseline in actual weekly PS volume at Week 24. (At week 24 of treatment)

NCT04627025 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials