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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04035668
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Bulgaria, China, Denmark, Germany, Hungary, Spain, Switzerland, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sjögren Syndrome
Arms & Interventions

Arms

Experimental: LOU064 Dose 1

high orally

Experimental: LOU064 Dose 2

high orally

Experimental: LOU064 Dose 3

middle orally

Experimental: LOU064 Dose 4

low orally

Placebo Comparator: Placebo

0 mg orally

Interventions

Drug: - LOU064

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

Drug: - Placebo

0mg hard gelatin capsule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Boston, Massachusetts

Status

Recruiting

Address

Novartis Investigative Site

Boston, Massachusetts, 02111

Novartis Investigative Site, Oklahoma City, Oklahoma

Status

Recruiting

Address

Novartis Investigative Site

Oklahoma City, Oklahoma, 73104

International Sites

Novartis Investigative Site, Woodville, South Australia, Australia

Status

Recruiting

Address

Novartis Investigative Site

Woodville, South Australia, 5011

Novartis Investigative Site, Hobart, Tasmania, Australia

Status

Recruiting

Address

Novartis Investigative Site

Hobart, Tasmania, 7000

Novartis Investigative Site, Clayton, Victoria, Australia

Status

Recruiting

Address

Novartis Investigative Site

Clayton, Victoria, 3168

Novartis Investigative Site, Gent, Belgium

Status

Recruiting

Address

Novartis Investigative Site

Gent, , 9000

Novartis Investigative Site, Sofia, Bulgaria

Status

Recruiting

Address

Novartis Investigative Site

Sofia, , 1612

Novartis Investigative Site, Hefei, Anhui, China

Status

Recruiting

Address

Novartis Investigative Site

Hefei, Anhui, 230001

Novartis Investigative Site, Nanjing, Jiangsu, China

Status

Recruiting

Address

Novartis Investigative Site

Nanjing, Jiangsu, 210008

Novartis Investigative Site, Chengdu, Sichuan, China

Status

Recruiting

Address

Novartis Investigative Site

Chengdu, Sichuan, 610041

Novartis Investigative Site, Glostrup, Denmark

Status

Recruiting

Address

Novartis Investigative Site

Glostrup, , 2600

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 10117

Novartis Investigative Site, Debrecen, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Debrecen, , 4032

Novartis Investigative Site, Sabadell, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Sabadell, Barcelona, 08208

Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain

Status

Recruiting

Address

Novartis Investigative Site

Valencia, Comunidad Valenciana, 46010

Novartis Investigative Site, Vigo, Pontevedra, Spain

Status

Recruiting

Address

Novartis Investigative Site

Vigo, Pontevedra, 36200

Novartis Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, , 08041

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28041

Novartis Investigative Site, Basel, Switzerland

Status

Recruiting

Address

Novartis Investigative Site

Basel, , 4031

Novartis Investigative Site, Lausanne, Switzerland

Status

Recruiting

Address

Novartis Investigative Site

Lausanne, , 1011

Novartis Investigative Site, Kaohsiung, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Kaohsiung, , 81346

Novartis Investigative Site, Taichung, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taichung, , 40447

Novartis Investigative Site, Taichung, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taichung, , 40705

Novartis Investigative Site, Swindon, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Swindon, , SN3 6BB