The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
1 x 30 mg tablet administered orally once daily
1 x 200 mg tablet administered orally once daily
1 x 40 mg tablet administered orally once daily
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
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).
Time frame: Week 12
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at 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.
Time frame: Baseline; Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at 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.
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1 x tablet administered orally once daily
1 x tablet administered orally once daily
1 x tablet administered orally once daily
AARR Arizona Arthritis & Rheumatology Research
Mesa, Arizona, United States
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
...and 43 more locations
Time frame: Baseline; Week 12
Change From Baseline in ESSDAI at 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.
Time frame: Baseline; Week 24
Change From Baseline in ESSPRI at 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.
Time frame: Baseline; Week 24