Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173

Phase 1

Active, not recruiting

• Conditions: Primary Sjögren's syndrome; MedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-004616-12-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-17
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To assess the safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome.<br>• To compare the effect of CDZ173 versus placebo on the patient-reported outcomes of primary Sjögren’s syndrome patients after 12 weeks of treatment (study week 13).<br>;Secondary Objective: • To assess the pharmacokinetics of CDZ173 in primary Sjögren’s<br>syndrome patients<br>• To evaluate the effect of CDZ173 versus placebo on clinical disease<br>outcomes in primary Sjögren’s syndrome patients after 12 weeks of<br>treatment<br>• To evaluate the changes in the physician global assessment of the<br>patient’s overall disease activity after 12 weeks of treatment.<br>• To evaluate the changes in the patients global assessment of their<br>disease activity after 12 weeks of treatment;Primary end point(s): EULAR Sjögren’s Syndrome Patient Reported Intensity (ESSPRI) change from baseline;Timepoint(s) of evaluation of this end point: Primary endpoint evaluation after 12 week treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) change from baseline<br>? Physician global assessment of the patient's overall disease activity (VAS) change from baseline<br>? Patient’s global assessment of their disease activity (VAS) change from baseline;Timepoint(s) of evaluation of this end point: Secondary endpoint evaluation after 12 week treatment.