Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögren's Disease with moderate or high systemic disease activity according to the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). The objectives of the study are to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
humanized monoclonal antibody
sterile preservative-free solution
Medvin Clinical Research
Menifee, California, United States
BioSolutions Clinical Research Center
Poway, California, United States
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24
Time frame: Baseline, Week 24
Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24
Time frame: Week 24
Proportion of STAR Responders (≥ 5 points) Over Time
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in EULAR Sjögren's Syndrome Disease Patient Reported Index (ESSPRI) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in ESSPRI Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Schirmer's Test at Week 24
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Medvin Clinical Research
Whittier, California, United States
International Medical Research
Daytona Beach, Florida, United States
Omega Research Debary, LLC
DeBary, Florida, United States
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Schaumburg, Illinois, United States
Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.
Skokie, Illinois, United States
Springfield Clinic Rheumatology
Springfield, Illinois, United States
Accurate Clinical Research, Inc
Lake Charles, Louisiana, United States
Accellacare (Salisbury)
Salisbury, North Carolina, United States
...and 6 more locations
Time frame: Baseline, Week 24
Change From Baseline in Schirmer's Test Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in clinESSDAI Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in FACIT-Fatigue Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D 5L) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in EQ-5D 5L Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56