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BTK Inhibitor
Remibrutinib 100 mg bid for Sjögren's Syndrome (LOUiSSe Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of SjS according to the 2016 ACR/EULAR criteria
Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4, week 8, week 12, week 16, week 20 and week 24
Awards & highlights
LOUiSSe Trial Summary
This trial is testing a new pill to see if it's safe and effective for treating Sjögren's syndrome, a chronic autoimmune disease.
Eligible Conditions
- Sjögren's Syndrome
LOUiSSe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLOUiSSe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 4, week 8, week 12, week 16, week 20 and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, week 8, week 12, week 16, week 20 and week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score at Week 24
Secondary outcome measures
Area Under the Blood Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4h) of Remibrutinib at Week 24
Area Under the Blood Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4h) of Remibrutinib at Week 4
Area Under the Blood Concentration-time Curve Within a Dosing Interval (Tau) at Steady-state (AUCtau) of Remibrutinib at Week 24
+13 moreLOUiSSe Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Remibrutinib 100 mg qdExperimental Treatment2 Interventions
Remibrutinib 100 mg once daily (qd)
Group II: Remibrutinib 100 mg bidExperimental Treatment1 Intervention
Remibrutinib 100 mg twice daily (bid)
Group III: PlaceboPlacebo Group1 Intervention
Placebo group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,568 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
1,681 Patients Enrolled for Sjögren's Syndrome
Frequently Asked Questions
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