BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04540497 (Inebilizumab in IgG4 Related 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 5 Jun 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
NCT04540497
Acronym
MITIGATE
Drug Name
Inebilizumab
Drug MoA
anti-CD19 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
IgG4 Related Disease
Human Patients
135
Sponsor
Amgen
Phase
Phase 3

Prediction of , index 1447

Prospective Prediction
Prediction Index
1447
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
121 days in advance
Readout Data Interpretation
-87% risk reduction in IgG4-RD flare compared with placebo.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal IgG4-RD disease model that has been permanently corrected.
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 Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Phase
Phase 3
Status
Active not recruiting
Enrollment
135
Lead sponsor
Amgen
Conditions
IgG4 Related Disease
Interventions
DRUG: Inebilizumab; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-12-04
Primary completion
2024-04-09
Completion
2028-10-31
Results first posted
2025-06-25
Primary outcomes
  • RCP: Time to Disease Flare (Up to Week 52)

NCT04540497 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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