Primary Sjögren's Syndrome Clinical Trial
Official title:
A Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CT
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.
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