A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

• Status: Recruiting
• Trial end date: 2024-07-19
• Target enrollment: 0
• Participant gender: All

Summary

LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor. This study is an adaptive phase 2 study designed to establish safety and efficacy and characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosis of SjS according to the 2016 ACR/EULAR criteria

• Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains

• Screening ESSPRI ≥ 5

• Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to screening

• Unstimulated salivary flow > 0 mL/min.

Exclusion Criteria:

• Sjögren's Syndrome overlap syndromes with another autoimmune disease as primary illness

• DMARDs or kinase inhibitors within 3 months prior to baseline above certain doses OR maintained during study

• Rituximab or other B cell depleting drug within 12 months of Screening .

• Current use of prednisone or equivalent > 15mg/d or dose change within 2 weeks prior to Screening

• Use of medication known to cause, as a major side effect, dry mouth / eyes

• HIV, Hepatitis C, Hepatitis B, known or suspected history of an ongoing, chronic or recurrent infectious disease such as tuberculosis

Other protocol-defined inclusion/exclusion criteria may apply at the end