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NCT03905525 (iscalimab in Sjogren's Syndrome): BVCT ex-ante prediction vs. reported outcome

On 1 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 31 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially insignificant (cohort 1) and commercially insufficient (cohort 2).

Clinical Trial

NCTID
NCT03905525
Acronym
TWINSS
Drug Name
iscalimab (CFZ533)
Drug MoA
anti-CD40 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Sjogren's Syndrome
Human Patients
273
Sponsor
Novartis
Phase
Phase 2

Prediction of , index 1631

Prospective Prediction
Prediction Index
1631
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in ESSDAI or ESSPRI inferior to efgartigimod that’s further inferior to rituximab)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in ESSDAI or ESSPRI)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
214 days in advance
Readout Data Interpretation
iscalimab in cohort 1 failed to achieve statistical significance in dose-response relationship for ESSDAI in 3/4 models; iscalimab 600mg in cohort 2 failed to achieve statistical significance in ESSPRI improvement compared with placebo (p=0.12). Hence; iscalimab hasn't met the efficacy threshold and further development discontinued
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially insignificant (cohort 1) and commercially insufficient (cohort 2)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)
Phase
Phase 2
Status
Completed
Enrollment
273
Lead sponsor
Novartis Pharmaceuticals
Conditions
Sjögren Syndrome
Interventions
DRUG: CFZ533; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-10-01
Primary completion
2022-09-28
Completion
2023-06-06
Results first posted
2026-05-18
Primary outcomes
  • Cohort 1: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) Score From Baseline at 24 Weeks as Compared to Placebo (Baseline, Week 24)
  • Cohort 2: Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) Score From Baseline at 24 Weeks as Compared to Placebo. (Baseline, Week 24)

NCT03905525 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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