Phase 2
N=152
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Sjogren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03100942 ↗Enrolled (actual)
152
Serious AEs
6.6%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline — 42.9; 43.2; 35.1; 26.5 percentage of participants — p=0.1597
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lanraplenib (Drug); Filgotinib (Drug); Tirabrutinib (Drug); Lanraplenib placebo (Drug); Filgotinib placebo (Drug); Tirabrutinib placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline |
42.9; 43.2; 35.1; 26.5 | 0.1597 |
| SECONDARY Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12 |
-2.5; -4.7; -3.2; -3.9 | 0.2066 |
| SECONDARY Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12 |
-1.0; -1.4; -1.4; -1.0 | 0.9446 |
| SECONDARY Change From Baseline in ESSDAI at Week 24 |
-4.3; -5.4; -4.0; -4.2 | 0.9564 |
| SECONDARY Change From Baseline in ESSPRI at Week 24 |
-1.1; -0.8; -1.2; -0.9 | 0.6782 |
Summary
The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).
Eligibility Criteria
Key Inclusion Criteria
- Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification
- Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) ≥ 5
- Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB)
Key Exclusion Criteria
- Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03100942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.