Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
- Conditions
- Sjogren's Syndrome
- Interventions
- Registration Number
- NCT03100942
- Lead Sponsor
- Gilead Sciences
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirabrutinib Tirabrutinib Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks. Lanraplenib Tirabrutinib placebo Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks. Filgotinib Lanraplenib placebo Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks. Placebo, then active treatment Lanraplenib placebo Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo Placebo, then active treatment Tirabrutinib placebo Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo Tirabrutinib Lanraplenib placebo Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks. Tirabrutinib Filgotinib placebo Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks. Placebo, then active treatment Filgotinib placebo Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo Lanraplenib Filgotinib placebo Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks. Filgotinib Tirabrutinib placebo Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks. Lanraplenib Lanraplenib Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks. Filgotinib Filgotinib Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks. Placebo, then active treatment Filgotinib Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo Placebo, then active treatment Tirabrutinib Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo Placebo, then active treatment Lanraplenib Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo
- Primary Outcome Measures
Name Time Method Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline Week 12 Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
- Secondary Outcome Measures
Name Time Method Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12 Baseline; Week 12 The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Change From Baseline in ESSPRI at Week 24 Baseline; Week 24 The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12 Baseline; Week 12 The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Change From Baseline in ESSDAI at Week 24 Baseline; Week 24 The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Trial Locations
- Locations (52)
AARR Arizona Arthritis & Rheumatology Research
🇺🇸Phoenix, Arizona, United States
Medvin Clinical Research
🇺🇸Covina, California, United States
Inland Rheumatology Clinical Trials, Inc.
🇺🇸Upland, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Omega Research Consultants LLC
🇺🇸DeBary, Florida, United States
Center for Rheumatology Immunology and Arthritis
🇺🇸Fort Lauderdale, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
IRIS Research and Development, LLC
🇺🇸Plantation, Florida, United States
North Georgia Rheumatology Group, PC
🇺🇸Lawrenceville, Georgia, United States
Scroll for more (42 remaining)AARR Arizona Arthritis & Rheumatology Research🇺🇸Phoenix, Arizona, United States