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NCT05350072 (Ianalumab in Sjögren Syndrome): BVCT ex-ante prediction vs. reported outcome

On 2 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 29 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically borderline significant and commercially probably insufficient (inferior to iscalimab).

Clinical Trial

NCTID
NCT05350072
Acronym
NEPTUNUS-1
Drug Name
Ianalumab (VAY736)
Drug MoA
anti-BAFFR inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Sjögren Syndrome
Human Patients
276
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3

Prediction of , index 1642

Prospective Prediction
Prediction Index
1642
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit inferior to iscalimab that’s further inferior to rituximab in ESSDAI as an adjunctive treatment to background therapies)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in ESSDAI as an adjunctive treatment to background therapies)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
484 days in advance
Readout Data Interpretation
Ianalumab achieved -1.3 placebo-adjusted difference in ESSDAI score at week 48 (p=0.05); inferior to iscalimab 300mg that achieved -3.0 placebo-adjusted difference in ESSDAI score at week 24 (p=0.0090; see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically borderline significant and commercially probably insufficient (inferior to iscalimab)
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, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)
Phase
Phase 3
Status
Completed
Enrollment
275
Lead sponsor
Novartis Pharmaceuticals
Conditions
Sjogren Syndrome
Interventions
BIOLOGICAL: VAY736; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-07-28
Primary completion
2025-05-07
Completion
2026-06-02
Primary outcomes
  • Change from baseline in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo (48 weeks)

NCT05350072 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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