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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 below

LOUiSSe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, week 8, week 12, week 16, week 20 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 4, week 8, week 12, week 16, week 20 and week 24 for reporting.

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 more

LOUiSSe 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

Find a Location

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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby Mar 2025