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NCT05817669 (Efgartigimod in Primary Sjögren's Syndrome): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 11 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05817669
Acronym
rho
Drug Name
Efgartigimod
Drug MoA
anti-FcRn antibody fragment
Drug Modality
antibody fragment biologic
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Primary Sjögren's Syndrome
Human Patients
34
Sponsor
argenx
Phase
Phase 2

Prediction of , index 1351

Prospective Prediction
Prediction Index
1351
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
559 days in advance
Readout Data Interpretation
efgartigimod failed to achieve statistical significance in ESSDAI compared with placebo (-7.0 vs -4.0)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome
Phase
Phase 2
Status
Completed
Enrollment
34
Lead sponsor
argenx
Conditions
Primary Sjögren's Syndrome
Interventions
BIOLOGICAL: Efgartigimod; BIOLOGICAL: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-04-04
Primary completion
2024-01-29
Completion
2024-02-12
Results first posted
2025-07-18
Primary outcomes
  • Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 (Week 24)

NCT05817669 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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