BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04973137 (Birtamimab in AL amyloidosis): BVCT ex-ante prediction vs. reported outcome

On 14 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 23 May 2025 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
NCT04973137
Acronym
AFFIRM-AL
Drug Name
Birtamimab
Drug MoA
anti-mis-light-chain
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
AL amyloidosis
Human Patients
220
Sponsor
Prothena Biosciences
Phase
Phase 3

Prediction of , index 1270

Prospective Prediction
Prediction Index
1270
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
313 days in advance
Readout Data Interpretation
birtamimab failed to meet the primary endpoint of time to all-cause mortality or the secondary endpoints
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 Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis
Phase
Phase 3
Status
Terminated
Enrollment
208
Lead sponsor
Prothena Biosciences Ltd.
Conditions
Light Chain (AL) Amyloidosis
Interventions
DRUG: Birtamimab; OTHER: Placebo; DRUG: Standard of Care Chemotherapy
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-08-30
Primary completion
2025-04-02
Completion
2025-06-20
Results first posted
2025-12-16
Primary outcomes
  • Time to All-cause Mortality for the Double Blind Phase (Time from the first dose of study drug until the pre-defined number of events (all-cause mortality) have been reached, assessed up to 39 months.)

NCT04973137 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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