Phase 2
Completed N=30
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
Source: ClinicalTrials.gov NCT02775916 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 — 20; 8; 1; 0 count of participants
Summary
This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 |
20; 8; 1; 0; 0; 0 | — |
| PRIMARY Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85 |
-1.778; -0.741 | — |
| SECONDARY Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85 |
-2.82; -3.34 | — |
| SECONDARY Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85 |
4.82; 4.42; 5.43; 1.10 | — |
| SECONDARY Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85) |
-8.80; -2.25 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (Physician VAS) After 12 Weeks of Treatment Day 85 |
-10.06; 0.91 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85 |
-4.83; 2.87 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary Sjögren's syndrome (pSS)
- ESSDAI score ≥ 6 at screening visit
Exclusion Criteria
- Secondary Sjögren's syndrome
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02775916). 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.