A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
NCT ID: NCT04035668
Last Updated: 2023-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
73 participants
INTERVENTIONAL
2019-07-12
2021-11-23
Brief Summary
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Detailed Description
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Of the initially planned two parts, only Part 1 of the study was conducted. In Part 1, the highest expected biologically active single dose of remibrutinib (100 mg) was tested in two different dosing regimens, a once daily dose (qd) or twice daily dose (bid), and compared to the placebo group. Each patient in Part 1 of the study underwent a screening period of up to 6 weeks, a treatment period of 24 weeks, and a follow-up period of 30 days post-treatment before the End of Study (EOS) visit. The total duration for each patient in the study, including Screening, was up to 35 weeks. For the treatment period, patients were randomized in a 1:1:1 ratio to one of the 3 treatment groups: remibrutinib 100 mg bid, remibrutinib 100 mg qd and placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Remibrutinib 100 mg bid
Remibrutinib 100 mg twice daily (bid)
Remibrutinib
Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.
Remibrutinib 100 mg qd
Remibrutinib 100 mg once daily (qd)
Remibrutinib
Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.
Placebo
Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.
Placebo
Placebo group
Placebo
Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.
Interventions
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Remibrutinib
Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.
Placebo
Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Tyne and Wear, , United Kingdom
Countries
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References
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Dorner T, Kaul M, Szanto A, Tseng JC, Papas AS, Pylvaenaeinen I, Hanser M, Abdallah N, Grioni A, Santos Da Costa A, Ferrero E, Gergely P, Hillenbrand R, Avrameas A, Cenni B, Siegel RM. Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjogren's syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial. Ann Rheum Dis. 2024 Feb 15;83(3):360-371. doi: 10.1136/ard-2023-224691.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
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2018-004387-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLOU064E12201
Identifier Type: -
Identifier Source: org_study_id
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