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

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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

Study Locations

United States
Novartis Investigative Site
Recruiting
Boston, 02111
Massachusetts
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73104
Oklahoma
United States
Novartis Investigative Site
Recruiting
San Antonio, 78284
Texas
United States
Australia
Novartis Investigative Site
Recruiting
Woodville, 5011
South Australia
Australia
Novartis Investigative Site
Recruiting
Hobart, 7000
Tasmania
Australia
Novartis Investigative Site
Recruiting
Clayton, 3168
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1612
-
Bulgaria
China
Novartis Investigative Site
Recruiting
Hefei, 230001
Anhui
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Denmark
Novartis Investigative Site
Recruiting
Glostrup, 2600
-
Denmark
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Spain
Novartis Investigative Site
Recruiting
Sabadell, 08208
Barcelona
Spain
Novartis Investigative Site
Recruiting
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Vigo, 36200
Pontevedra
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08041
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4031
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1011
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung, 81346
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40447
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40705
-
Taiwan
United Kingdom
Novartis Investigative Site
Recruiting
Liverpool, L9 7AL
-
United Kingdom
Novartis Investigative Site
Recruiting
Swindon, SN3 6BB
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]