Phase 2
Completed N=69
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Source: ClinicalTrials.gov NCT02291029 ↗Enrolled (actual)
69
Serious AEs
4.4%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) — 12.0; 11.8; 10.6; 11.0 units on a scale — p=0.397
Summary
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) |
12.0; 11.8; 10.6; 11.0; 12.7; 10.4 | 0.397 |
| SECONDARY Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) |
6.75; 7.00; 6.71; 7.18; 7.00; 6.00 | 0.205 |
| SECONDARY Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS) |
57.9; 57.8; 51.9; 47.9; 50.4; 47.1 | 0.161 |
| SECONDARY Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) |
47.13; 73.00; 58.43; 54.91; 63.69; 52.08 | 0.456 |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score |
42.218; 31.215; 38.163; 38.819; 40.374; 36.123 | 0.172 |
| SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score |
46.838; 43.118; 37.071; 39.512; 48.076; 43.660 | 0.986 |
| SECONDARY Change From Baseline in Multidimensional Fatigue Inventory (MFI) |
54.1; 78.0; 70.0; 66.2; 53.5; 69.8 | 0.807 |
Eligibility Criteria
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 event
- Clinically significant systemic infection
- Significant elevated risk for infection
Data sourced from ClinicalTrials.gov (NCT02291029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.