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NCT04598451 (Efgartigimod in Pemphigus): BVCT ex-ante prediction vs. reported outcome

On 4 Jul 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 20 Dec 2023 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
NCT04598451
Acronym
ADDRESS
Drug Name
Efgartigimod
Drug MoA
anti-FcRn antibody fragment
Drug Modality
antibody fragment biologic
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Pemphigus
Human Patients
222
Sponsor
argenx
Phase
Phase 3

Prediction of , index 963

Prospective Prediction
Prediction Index
963
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
169 days in advance
Readout Data Interpretation
primary or secondary endpoints not met.
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 Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)
Phase
Phase 3
Status
Completed
Enrollment
222
Lead sponsor
argenx
Conditions
Pemphigus Vulgaris; Pemphigus Foliaceus
Interventions
BIOLOGICAL: efgartigimod PH20 SC; OTHER: Placebo; DRUG: prednisone
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-12-01
Primary completion
2023-08-22
Completion
2023-08-22
Results first posted
2024-10-01
Primary outcomes
  • Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy (up to 30 weeks treatment period)

NCT04598451 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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