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This study evaluates the safety and efficacy of multiple doses of CFZ533 compared with placebo in two distinct groups of patients with Sjögren's syndrome. It included patients aged 18 and older diagnosed with Sjögren's syndrome per the ACR/EULAR 2016 criteria and positive for anti-Ro/SSA antibodies. It was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Signed informed consent * Male or female patient ≥ 18 years of age * Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017) * Seropositive for anti-Ro/SSA antibodies * Stimulated whole salivary flow rate of ≥ 0.1 mL/min Inclusion criteria specific for Cohort 1: * ESSDAI ≥ 5 within the 8 predefined organ domains * ESSPRI score of ≥5 Inclusion criteria specific for Cohort 2: * ESSDAI \< 5 within 8 domains scored for inclusion criterion for Cohort 1 * ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5 Exclusion Criteria: * Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness * Use of other investigational drugs * Prior use of B cell depleting therapies, abatacept or any other immunosuppressants unless specifically allowed be the protocol. * Use of steroids at dose \>10 mg/day. * Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or Meibomian gland disease (this criterion applies only to patients considered for Cohort 2) * Active viral, bacterial or other infections requiring systemic treatment * Receipt of live/attenuated vaccine within a 2-month period prior to randomization. * Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). * Evidence of active tuberculosis (TB) infection.