Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CFZ533 active - Cohort 1, CFZ533 active- Cohort 1
CFZ533 active · 1 trial · 1 indication
The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
| Arm | Type | Description |
|---|---|---|
| CFZ533 active- Cohort 2 | EXPERIMENTAL | multiple doses of CFZ533 intravenous infusion |
| CFZ533 placebo- Cohort 2 | PLACEBO_COMPARATOR | multiple doses of placebo intravenous infusion |
| CFZ533 active - Cohort 1 | EXPERIMENTAL | multiple doses of CFZ533 s.c. injection |
| CFZ533 placebo - Cohort 1 | PLACEBO_COMPARATOR | multiple doses of placebo s.c. injection |
| CFZ533 Treatment Arm 1 - Cohort 3 | EXPERIMENTAL | multiple doses of CFZ533 s.c. injection |
| CFZ533 Treatment Arm 2 - Cohort 3 | EXPERIMENTAL | Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection |
| Name | Type | Description |
|---|---|---|
| CFZ533 active - Cohort 1 | DRUG | multiple doses of CFZ533 s.c. injection |
| CFZ533 placebo- Cohort 1 | DRUG | multiple doses of placebo s.c. injection |
| CFZ533 active - Cohort 2 | DRUG | multiple doses of CFZ533 intravenous infusion |
| CFZ533 placebo - Cohort 2 | DRUG | multiple doses of placebo intravenous infusion |
| CFZ533 active -Cohort 3 | DRUG | multiple doses of CFZ533 s.c. injection |
| CFZ533 active - Cohort 3 | DRUG | Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection |
Inclusion Criteria: * Diagnosis of primary Sjögren's syndrome * ESSDAI score ≥ 6 Exclusion Criteria: * Secondary Sjögren's syndrome * Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives. * At significant risk for thromboembolic ...