Sjögren's syndrome
Conditions
Brief summary
Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (EOT)
Detailed description
Occurrence of treatment emergent adverse events (both serious and non-serious) during the study and occurrence of treatment emergent abnormal vital signs, laboratory and ECG data over the study period., Change from baseline in SGUS parameters over the study period, Serum ianalumab concentrations during treatment and follow up. PK parameters AUCtau, AUClast, AUCinf, Cmax, Tmax, T1/2 after the last dose (if data permits) and any other parameters as required, Serum anti-ianalumab antibody (ADA assay) and incidence of ADA positive patients over the study period, Change from baseline in mean stimulated and unstimulated salivary flow rate changes over the study period
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (EOT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of treatment emergent adverse events (both serious and non-serious) during the study and occurrence of treatment emergent abnormal vital signs, laboratory and ECG data over the study period., Change from baseline in SGUS parameters over the study period, Serum ianalumab concentrations during treatment and follow up. PK parameters AUCtau, AUClast, AUCinf, Cmax, Tmax, T1/2 after the last dose (if data permits) and any other parameters as required, Serum anti-ianalumab antibody (ADA assay) and incidence of ADA positive patients over the study period, Change from baseline in mean stimulated and unstimulated salivary flow rate changes over the study period | — |
Countries
France
Outcome results
None listed