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

  • STATUS
    Recruiting
  • End date
    Aug 18, 2023
  • participants needed
    252
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 January 2021

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 Sjgren's syndrome.

Details
Condition Sicca Syndrome, Sjogren's Syndrome
Treatment Placebo, LOU064
Clinical Study IdentifierNCT04035668
SponsorNovartis Pharmaceuticals
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Sjogren's Syndrome or Sicca Syndrome?
Do you have any of these conditions: Sicca Syndrome or Sjogren's Syndrome?
Do you have any of these conditions: Sjogren's Syndrome or Sicca Syndrome?
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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