Phase 2
N=30
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
Primary Sjögren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02775916 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 — 20; 8; 1; 0 count of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CDZ173 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2017
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 | — |
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.
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.