UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome

Exclusion Criteria

• •Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögren's syndrome (eg, rheumatoid arthritis, systemic lupus erythematosus
• •Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host disease)
• •Subject has significant fibromyalgia syndrome as defined by the American College of Rheumatology 2010 classification criteria
• •Subject has significant depression as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders
• •Subject has oral candidiasis
• •Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months after the final dose of the investigational medicinal product (IMP)
• •Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, T-cell deficiencies, or human T-cell leukemia virus type 1 (HTLV-1)
• •o Positive testing for HIV-1/2 at Screening (Visit 1)
• •Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B (HBV) or hepatitis C (HCV)
• •* Positive testing for HBV at Screening (Visit 1)
• •* Positive testing for HCV at Screening (Visit 1)
• •A subject with a history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening (Visit 1) to randomization, as per the Investigator's clinical judgment is also excluded Subject must have completed any prior anti-infective therapy prior to the first dose of study drug with the exception of anti-infectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be used for these purposes
• •Subject is at a particularly high risk of significant infection due to their lifestyle and/or occupation
• •Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1)
• •Subject has significant hematologic abnormalities of hemoglobin \<10.0 g/dL, or white blood cell (WBC) \<2000 /mm\^3, or absolute neutrophil count \<1000 /mm\^3, or platelets \<100,000 /mm\^3 at Screening (Visit 1)
• •Subject has a history of cancer