This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS). The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Ss0004 34
Brest, France
Ss0004 30
Le Kremlin-Bicêtre, France
Ss0004 35
Strasbourg, France
Ss0004 20
L’Aquila, Italy
Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
Time frame: Week 12
Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
Time frame: Week 4
Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
Time frame: Week 8
Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)
Time frame: Week 4
Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)
Time frame: Week 8
Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)
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Ss0004 21
Palermo, Italy
Ss0004 22
Udine, Italy
Ss0004 42
Córdoba, Spain
Ss0004 40
Villajoyosa, Spain
Ss0004 50
Stockholm, Sweden
Ss0004 01
Birmingham, United Kingdom
...and 4 more locations
Time frame: Week 12
Change from Baseline to Week 4 in the stimulated salivary flow
The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant
Time frame: Week 4
Change from Baseline to Week 8 in the stimulated salivary flow
The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant
Time frame: Week 8
Change from Baseline to Week 12 in the stimulated salivary flow
The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant
Time frame: Week 12
Change from Baseline to Week 4 in the unstimulated salivary flow
The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation
Time frame: Week 4
Change from Baseline to Week 8 in the unstimulated salivary flow
The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation.
Time frame: Week 8
Change from Baseline to Week 12 in the unstimulated salivary flow
The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation
Time frame: Week 12
Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia)
The Schirmer's test measures basic tear function. A 35 mm x 5mm size paper strip is inserted into each eye for a period of 5 minutes to measure the production of tears.
Time frame: Week 12