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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Sjögren Syndrome

In brief

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 Bruton's tyrosine kinase (BTK) inhibitor.

Key facts

Study ID

NCT04035668

Run by

Novartis Pharmaceuticals

People needed

73

Starts

2019-07-12

Expected to finish

2021-11-23

Last updated by the study team

2023-01-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Woodville, South Australia, Australia
• Novartis Investigative Site — Hobart, Tasmania, Australia
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Hefei, Anhui, China
• Novartis Investigative Site — Nanjing, Jiangsu, China
• Novartis Investigative Site — Chengdu, Sichuan, China
• Novartis Investigative Site — Glostrup Municipality, Denmark
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Sabadell, Barcelona, Spain
• Novartis Investigative Site — Vigo, Pontevedra, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Basel, Switzerland
• Novartis Investigative Site — Lausanne, Switzerland
• Novartis Investigative Site — Taichung, Taiwan ROC, Taiwan
• Novartis Investigative Site — Kaohsiung City, Taiwan
• Novartis Investigative Site — Taichung, Taiwan
• Novartis Investigative Site — Taichung, Taiwan
• Novartis Investigative Site — Liverpool, United Kingdom
• Novartis Investigative Site — Swindon, United Kingdom

Full record on ClinicalTrials.gov

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