The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
631
subcutaneous efgartigimod PH20 SC given by prefilled syringe
subcutaneous placebo PH20 SC given by prefilled syringe
Change from baseline in clinESSDAI score at week 48
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
Time frame: Up to 48 weeks
Change from baseline in ESSDAI score at week 48
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).
Time frame: Up to 48 weeks
Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
Time frame: Up to 48 weeks
Proportion of responders on STAR (defined as ≥ 5 points) at week 48
Sjögren's Tool for Assessing Response ( STAR) has been developed as a composite score to assess the efficacy of treatments for PSjD in 5 domains. Patients are classified as STAR responders when they reach ≥ 5 of 9 points.
Time frame: Up to 48 weeks
Change from baseline in DiSSA joint pain item at week 48
Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).
Time frame: Up to 48 weeks
Change from baseline in DiSSA total score at week 48
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Providence Medical Foundation
Fullerton, California, United States
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Clearwater, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
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Greenacres City, Florida, United States
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Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).
Time frame: Up to 48 weeks
Change from baseline in DiSSA sicca domain at week 48
Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).
Time frame: Up to 48 weeks
Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).
Time frame: Up to 48 weeks
Change from baseline in clinESSDAI score at week 24
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
Time frame: Up to 24 weeks