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NCT05415410 (Apraglutide in Graft Versus Host Disease.): BVCT ex-ante prediction vs. reported outcome

On 5 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 28 Mar 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD.

Clinical Trial

NCTID
NCT05415410
Acronym
STARGAZE
Drug Name
Apraglutide
Drug MoA
GLP2R agonist
Drug Modality
peptide drug
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Graft Versus Host Disease (GVHD).
Human Patients
31
Sponsor
Ironwood Pharmaceuticals
Phase
Phase 2

Prediction of , index 466

Prospective Prediction
Prediction Index
466
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
83 days in advance
Readout Data Interpretation
phase 2a safety primary endpoint met and showed sustained response.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Single-blind Trial to Evaluate the Safety and Efficacy of Apraglutide in Subjects With Grade II to IV (MAGIC) Steroid Refractory Gastrointestinal (GI) Acute Graft Versus Host Disease on Best Available Therapy
Phase
Phase 2
Status
Terminated
Enrollment
31
Lead sponsor
VectivBio AG
Conditions
GVHD
Interventions
DRUG: Apraglutide
Design
Randomized · Parallel · Single
Primary purpose
Treatment
Start
2022-05-25
Primary completion
2024-12-17
Completion
2024-12-17
Results first posted
2025-10-20
Primary outcomes
  • Number of Participants With Adverse Events (AEs) (Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks)
  • Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) (From first dose of study drug through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks)
  • Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs (Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial)
  • Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, Weeks 26, 52, 104/End of Trial)
  • Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) (Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial)

NCT05415410 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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