Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome

NCT ID: NCT02495129

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-09-30

Brief Summary

This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected [Zr-89]-rituximab PET/CT method is a valid method to assess B cells in salivary glands of pSS patients. In Part 1 and Part 2 no IMP will be applied to the subjects. In Part 3, pSS patients (n=12) will receive the IMP, VAY736. Posted information will be focused on Part 3.

The overarching purpose of this study is to test a new drug (VAY736) for the treatment of pSS. In pSS, the salivary glands (the glands that produce saliva) and other organs are affected by inflammation. A certain type of white blood cells called B cells prominently infiltrate the salivary glands in pSS, whereas they are not present in healthy salivary glands. Scientific evidence suggests that B cells may be involved in the disease process in pSS and that eliminating B cells may benefit patients with pSS. This study will test a new imaging method and a new treatment for pSS. Both the imaging method and the treatment are specific for B cells.

Conditions

Primary Sjögren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

VAY736 lower dose

12 evaluable patients will be enrolled and randomized (at a ratio of 1:1) to receive either a lower dose or a higher dose of the study drug (VAY736)

Group Type: EXPERIMENTAL

VAY736 lower dose

Intervention Type: DRUG

Patients will receive a total number of 3 monthly subcutaneous injections with the lower dose of VAY736

VA736 higher dose

12 evaluable patients will be enrolled and randomized (at a ratio of 1:1) to receive either a lower dose or a higher dose of the study drug (VAY736)

Group Type: EXPERIMENTAL

VAY736 higher dose

Intervention Type: DRUG

Patients will receive a total number of 3 monthly subcutaneous injections with the higher dose of VAY736

Interventions

VAY736 lower dose

Patients will receive a total number of 3 monthly subcutaneous injections with the lower dose of VAY736

Intervention Type: DRUG

VAY736 higher dose

Patients will receive a total number of 3 monthly subcutaneous injections with the higher dose of VAY736

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Fullfilled consensus criteria for primary Sjögren's syndrome
• Patients must have elevated serum levels for some Sögren Syndorme specific parameters such as antinuclear antibodies (ANA), rheumatoid factor (RF) etc.

• healthy male and female people 18-75 years of age

Exclusion Criteria

• Patients that are suffering from Secondary Sjögren's syndrome.
• Patients previously treated with monoclonal antibody treatments such as rituximab, infliximab, adalimumab, etc.

Part 2

• Use of other investigational drugs at the time of enrollment
• Exposure to a sizeable degree of radiation (≥ 5 mSv) in an investigational research study in the past year prior to this study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CVAY736X2103

Identifier Type: -

Identifier Source: org_study_id