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NCT04512235 (CAEL-101 in AL amyloidosis): BVCT ex-ante prediction vs. reported outcome

On 11 Apr 2025, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 16 Jul 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
NCT04512235
Acronym
CARES
Drug Name
CAEL-101 (anselamimab)
Drug MoA
IgG1 monoclonal antibody that binds to a conformational neoepitope contained with the first 18 amino acids of misfolded human immunoglobulin light chains
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
AL amyloidosis
Human Patients
281
Sponsor
AstraZeneca
Phase
Phase 3

Prediction of , index 1967

Prospective Prediction
Prediction Index
1967
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to CyBorD in all-cause mortality/frequency of hospitalization/KCCQ/6MWT inferior to daratumumab + CyBorD)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit to CyBorD in all-cause mortality/frequency of hospitalization/KCCQ/6MWT compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
96 days in advance
Readout Data Interpretation
Anselamimab failed to achieve the primary endpoint
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, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis
Phase
Phase 3
Status
Active not recruiting
Enrollment
281
Lead sponsor
Alexion Pharmaceuticals, Inc.
Conditions
AL Amyloidosis
Interventions
DRUG: CAEL-101; OTHER: Placebo; DRUG: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-11-03
Primary completion
2025-04-08
Completion
2027-04-08
Results first posted
2026-06-17
Primary outcomes
  • A Hierarchical Combination of Time to All-cause Mortality and Frequency of Cardiovascular Hospitalizations (CVHs) Analyzed by Win Ratio (Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-49 months after the study randomization.))
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-49 months after the study randomization.))

NCT04512235 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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