Status:
TERMINATED
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Sjögren Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome. LOU064 is an oral Br...
Detailed Description
This study was planned as an adaptive Phase 2 randomized, double-blind, placebo-controlled, multi-center, integrated dose-ranging study to evaluate the safety and efficacy of multiple remibrutinib dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04035668
Start Date
July 12 2019
End Date
November 23 2021
Last Update
January 30 2023
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
2
Novartis Investigative Site
Woodville, South Australia, Australia, 5011
3
Novartis Investigative Site
Hobart, Tasmania, Australia, 7000
4
Novartis Investigative Site
Clayton, Victoria, Australia, 3168