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NCT04524273 (Inebilizumab in generalized myasthenia gravis): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Sep 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

NCTID
NCT04524273
Acronym
MINT
Drug Name
Inebilizumab
Drug MoA
anti-CD19 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
generalized myasthenia gravis (gMG)
Human Patients
238
Sponsor
Amgen
Phase
Phase 3

Prediction of , index 1446

Prospective Prediction
Prediction Index
1446
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
232 days in advance
Readout Data Interpretation
inebilizumab achieved 1.9 placebo-adjusted MG-ADL score reduction at week 26 (p < 0.0001); numerically superior to efgartigimod's 1.6-1.7 placebo-adjusted MG-ADL score reduction at week 8-11 (doi- 10.1212/WNL.0000000000007600); commercially sufficient for unsaturated market.
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 Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
Phase
Phase 3
Status
Active not recruiting
Enrollment
238
Lead sponsor
Amgen
Conditions
Myasthenia Gravis
Interventions
DRUG: inebilizumab; DRUG: IV Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-10-15
Primary completion
2024-05-28
Completion
2029-06-07
Results first posted
2026-03-10
Primary outcomes
  • Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population (Baseline and Week 26)

NCT04524273 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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