BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05225675 (ARGX-117 in Multifocal Motor Neuropathy): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Jan 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (no approved SoC for reducing IVIg rescue.

Clinical Trial

NCTID
NCT05225675
Acronym
ARDA
Drug Name
ARGX-117
Drug MoA
C2 mAb inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Multifocal Motor Neuropathy
Human Patients
54
Sponsor
argenx
Phase
Phase 2

Prediction of , index 961

Prospective Prediction
Prediction Index
961
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
39 days in advance
Readout Data Interpretation
91% placebo-adjusted reduction in the need for IVIg rescue.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (no approved SoC for reducing IVIg rescue
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
Phase
Phase 2
Status
Completed
Enrollment
54
Lead sponsor
argenx
Conditions
Multifocal Motor Neuropathy
Interventions
BIOLOGICAL: ARGX-117; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-03-31
Primary completion
2024-06-04
Completion
2024-06-04
Results first posted
2026-05-08
Primary outcomes
  • Number of Participants With AEs and SAEs (Up to 80 weeks)

NCT05225675 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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