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

  • End date
    Jul 19, 2024
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 July 2021


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 Sjgren's syndrome.

Condition Sicca Syndrome, Sjogren's Syndrome
Treatment Placebo, LOU064
Clinical Study IdentifierNCT04035668
SponsorNovartis Pharmaceuticals
Last Modified on21 July 2021


Yes No Not Sure

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

Sjgren'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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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