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NCT04133909 (mepolizumab in Chronic Obstructive Pulmonary Disease): BVCT ex-ante prediction vs. reported outcome

On 13 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 Sep 2024 readout is classified on the dashboard as False Negative (FN), a missed prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04133909
Acronym
MATINEE
Drug Name
mepolizumab
Drug MoA
anti-IL5 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Chronic Obstructive Pulmonary Disease (COPD)
Human Patients
806
Sponsor
GSK
Phase
Phase 3

Prediction of , index 1749

Prospective Prediction
Prediction Index
1749
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in exacerbation ratio)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in exacerbation ratio)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
24 days in advance
Readout Data Interpretation
primary endpoint of annualized exacerbation reduction was met with statistically significant and clinically meaningful efficacy.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of eosinophil count in the clinical setting of COPD.
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
False Negative (FN)

ClinicalTrials.gov record

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

Official title
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)
Phase
Phase 3
Status
Completed
Enrollment
806
Lead sponsor
GlaxoSmithKline
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
BIOLOGICAL: Mepolizumab; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2019-10-30
Primary completion
2024-08-08
Completion
2024-08-08
Results first posted
2025-08-15
Primary outcomes
  • Annualized Rate of Moderate or Severe Exacerbations (Up to Week 104)

NCT04133909 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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