Clinical trial NCT02610543 (phase 2, status: terminated)
Conditions: primary sjögren's syndrome
ICD codes: D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0
Drugs: ucb5857, placebo
SMILES: [O-][N+]1=CC(=CC=C1)C1=NC2=C(Cl)C=CC=C2C=C1[C@@H](NC1=NC=NC2=CC=CN=C12)C(F)(F)F, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    study stopped prematurely due to enrolment challenges.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be between 18 years and 75 years of age

          -  Women of childbearing potential must agree to use a highly effective method of birth
             control during the study and for a period of 3 months after their final dose of study
             drug. Women not agreeing to use birth control must be of non-childbearing potential
             defined as; permanently sterile, congenitally sterile or postmenopausal for at least 2
             years prior to Screening (Visit 1). Women of childbearing potential are required to
             have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be
             negative by urine testing prior to the first dose of study drug at Week 1 (Visit 2)
             Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active during the study and for 3 months after the last dose of study
             drug In addition female partner of childbearing potential of male subject must be
             willing to use a highly effective method of contraception for duration of study and
             for 3 months after last dose of study drug

          -  Subject must meet the 2002 AECG (American-European Consensus Group) criteria for
             Primary Sjӧgren's Syndrome

          -  Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti
             SSB/La autoantibodies

        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