EUCTR2014-004616-12-DE
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary Sjögren's syndrome
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of primary Sjögren’s syndrome
- •ESSDAI score \= 6 at screening visit;
- •Other protocol\-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 25
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 5
Exclusion Criteria
- •Secondary Sjögren’s syndrome
- •Other protocol\-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Not specified
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