BioinvestGPT

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NCT04039113 (Tezepelumab in Chronic Obstructive Pulmonary Disease): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 19 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04039113
Acronym
COURSE
Drug Name
Tezepelumab
Drug MoA
anti-TSLP alarmin mAb inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Chronic Obstructive Pulmonary Disease (COPD)
Human Patients
337
Sponsor
Amgen
Phase
Phase 2

Prediction of , index 1443

Prospective Prediction
Prediction Index
1443
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
104 days in advance
Readout Data Interpretation
17% reduced annualized rate of COPD exacerbation compared with placebo (p=0.1042).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)
Phase
Phase 2
Status
Completed
Enrollment
337
Lead sponsor
AstraZeneca
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
BIOLOGICAL: Tezepelumab; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-07-30
Primary completion
2023-11-10
Completion
2024-01-31
Results first posted
2025-02-18
Primary outcomes
  • Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD. (From randomisation up to Week 52)

NCT04039113 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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