Safety, Pharmacokinetics and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

Last updated: February 5, 2016
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT02679612
CCDZ173X2203
  • Ages 18-75
  • Both

Study Summary

This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K Delta inhibitor, for 12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide basis for further development of the compound for the treatment of primary Sjögren's syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of primary Sjögren's syndrome (pSS)

  • ESSDAI score ≥ 6;

Exclusion

Exclusion Criteria:

  • Secondary Sjögren's syndrome Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 27
Study Start date:
May 01, 2016
Estimated Completion Date:
December 31, 2017

Study Description

This study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K delta inhibitor, for 12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide the basis for further development of the compound for the treatment of primary Sjögren's syndrome.