Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223583

Enrollment

Registered

2017-07-06

Start date

2017-06-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren's Syndrome

Interventions

investigational material(s) Generic name etc : VAY736 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Fulfilled revised European US consensus criteria for pSS * Seropositive at screening for anti-Ro/SSA antibodies * Documented salivary/lacrimal gland biopsy result confirming pSS diagnosis prior to the baseline visit

Exclusion criteria

Exclusion criteria: * Secondary Sjogren's syndrome * Use of other investigational drugs * Active viral, bacterial or other infections * Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening Other protocol defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy Dose response [ Time Frame: 24 weeks ] Dose response measured by change multi-dimensional disease activity as assessed by the physician	—

Secondary

Measure	Time frame
efficacy Dose response [ Time Frame: 24 weeks ] Dose response measured by change in patient-reported disease activity measures other Quality of Life [ Time Frame: 24 weeks ] Change in quality of life measure by PRO efficacy Salivary gland function [ Time Frame: 24 weeks ] Change in salivary gland function measure by flow rate safety Safety [ Time Frame: 24 weeks ] Incidence of Adverse events and Serious Adverse Events	—

Measure

Time frame

efficacy Dose response [ Time Frame: 24 weeks ] Dose response measured by change in patient-reported disease activity measures other Quality of Life [ Time Frame: 24 weeks ] Change in quality of life measure by PRO efficacy Salivary gland function [ Time Frame: 24 weeks ] Change in salivary gland function measure by flow rate safety Safety [ Time Frame: 24 weeks ] Incidence of Adverse events and Serious Adverse Events

—

Countries

Europe, Japan, North America

Contacts

Public ContactHiroyuki Yamada

Novartis Pharma K. K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026