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

Novartis

Status and phase: Completed; Phase 2

Conditions: Primary Sjögren's Syndrome

Treatments: Drug: CDZ173; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02775916

CCDZ173X2203

2014-004616-12 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

CDZ173

Experimental group

Description:

Capsule

Treatment:

Drug: CDZ173

Placebo

Placebo Comparator group

Description:

Capsule matching Placebo

Treatment:

Drug: Placebo