Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
Phase 2
Completed
NCT03905525
| Condition | Sjögren Syndrome |
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| Phase | Phase 2 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Completed |
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| Enrollment | 273 participants |
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| Interventions | CFZ533 |
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| Start date | Oct 1, 2019 |
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| Completion date | Sep 28, 2022 |
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| Results posted | May 18, 2026 |
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Summary
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
Cohort 1: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) Score From Baseline at 24 Weeks as Compared to Placebo
Baseline, Week 24 · Unit on a scale
| Cohort 1 / Arm D (Period 1): Placebo | -4.0 ± 0.73 Unit on a scale |
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| Cohort 1/Arm C: CFZ533 150 mg | -7.0 ± 0.70 Unit on a scale |
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| Cohort 1/Arm B: CFZ533 300 mg | -5.4 ± 0.71 Unit on a scale |
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| Cohort 1/Arm A: CFZ533 600 mg | -6.9 ± 0.73 Unit on a scale |
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| p-value | 0.0025 |
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| LS Mean difference CFZ533-Placebo | -3.0 (95% CI -4.9–-1.1) |
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Cohort 2: Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) Score From Baseline at 24 Weeks as Compared to Placebo.
Baseline, Week 24 · Unit on a scale
| Cohort 2/Arm F: Placebo | -1.21 ± 0.271 Unit on a scale |
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| Cohort 2/Arm E: CFZ533 600 mg | -1.79 ± 0.258 Unit on a scale |
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| p-value | 0.1210 |
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| LS Mean difference CFZ533-Placebo | -0.57 (95% CI -1.30–0.15) |
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Open in BENITIONS
View on ClinicalTrials.gov
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