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

An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)

ClinicalTrials.gov Identifier: NCT04035668

Novartis Reference Number: CLOU064E12201

Last Update: Nov 16, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Sjögren Syndrome

Phase

Phase 2

Overall status

Recruiting

Enrollment count

252 participants

Start date

Jul 12, 2019

Completion date

Aug 18, 2023

Gender

All

Age(s)

18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

LOU064

10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules

Drug

Placebo

0mg hard gelatin capsule

Eligibility 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