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NCT04701164 (ANX005 in Guillain-Barre Syndrome): BVCT ex-ante prediction vs. reported outcome

On 22 Dec 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 4 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically mostly insignificant (negative dose-response relationship) and commercially insufficient.

Clinical Trial

NCTID
NCT04701164
Drug Name
ANX005
Drug MoA
C1q mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Guillain-Barre Syndrome
Human Patients
216
Sponsor
Annexon
Phase
Phase 3

Prediction of , index 344

Prospective Prediction
Prediction Index
344
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
165 days in advance
Readout Data Interpretation
primary endpoint (GBS-DS) with lower dosage 30mg/kg yet not met with higher dosage 75mg/kg; none of the secondary endpoints met.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically mostly insignificant (negative dose-response relationship) and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects With Guillain-Barré Syndrome
Phase
Phase 3
Status
Completed
Enrollment
242
Lead sponsor
Annexon, Inc.
Conditions
Guillain-Barre Syndrome
Interventions
DRUG: ANX005; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-12-17
Primary completion
2024-04-20
Completion
2024-04-20
Primary outcomes
  • GBS Disability Score (GBS-DS) at Week 8 (Week 8)
  • Number of Participants with Adverse Events (Through Month 6)

NCT04701164 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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