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NCT04851964 (tezepelumab in pancreas Neoplasm Stomach Neoplasm Gastrointestinal Neoplasms…): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

Acronym
WAYPOINT
Drug Name
tezepelumab
Drug MoA
anti-TSLP inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
pancreas Neoplasm Stomach Neoplasm Gastrointestinal Neoplasms Digestive System Neoplasm Neoplasms by Site Neoplasms
Human Patients
416
Sponsor
Amgen / AstraZeneca
Phase
Phase 3

Prediction of , index 1444

Prospective Prediction
Prediction Index
1444
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient yet moderate additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant yet moderate additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
277 days in advance
Readout Data Interpretation
tezepelumab achieved the efficacy primary endpoint of total endoscopic nasal polyp score at week 52 and mean nasal obstruction score by week 52
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)
Phase
Phase 3
Status
Completed
Enrollment
416
Lead sponsor
AstraZeneca
Conditions
Chronic Rhinosinusitis With Nasal Polyps
Interventions
BIOLOGICAL: Experimental: Tezepelumab; OTHER: Placebo; DRUG: Mometasone furoate or equivalent intranasal corticosteroid
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-04-22
Primary completion
2024-09-23
Completion
2024-12-11
Results first posted
2026-01-27
Primary outcomes
  • Change From Baseline in Total Nasal Polyp Score at Week 52 (Baseline to Week 52)
  • Change From Baseline in Bi-weekly Mean Nasal Congestion Score (NCS) at Week 52 (Baseline to Week 52)

NCT04851964 on ClinicalTrials.gov

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