A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Placebo; RO5459072
Intervention description: Matching-placebo capsules will be administered orally, 2 times a day with food.; RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
Intervention MeSH terms: Petesicatib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group
      study designed to evaluate the effects of RO5459072 treatment on disease activity and
      symptoms of Sjogren's syndrome in adult participants with moderate to severe primary
      Sjogren's syndrome. The total duration of the study for each participant will be
      approximately 18 weeks (including screening).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of primary Sjogren's syndrome according to the revised American-European
             Consensus Group (AECG) criteria

          -  ESSDAI score greater than or equal to (>/=) 5

          -  ESSPRI score >/=5

          -  Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or
             anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening

          -  Negative pregnancy test at screening and baseline (for women only)

          -  Willing to comply with the study procedures and restrictions, including measures to
             prevent pregnancy and restrictions on sperm donation

        Exclusion Criteria:

          -  A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria

          -  Severe complications of Sjogren's syndrome

          -  Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy
             within 6 months prior to the screening visit

          -  Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day

          -  A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human
             immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal,
             yeast or bacterial infection at screening

          -  A history suggesting reduced immune function or any other conditions predisposing
             participants to serious infection

          -  A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance
             (MGUS), or any other malignancies within the past 5 years

          -  A diagnosis of fibromyalgia or significant depression

          -  Having any concomitant disease or condition that could interfere with the conduct of
             the study, or that would pose an unacceptable risk to the individual

          -  Participation in an investigational drug or device study within 3 months prior to
             screening

          -  Inability to comply with the study protocol for any other reason

          -  Women who are lactating, breastfeeding or planning to nurse

          -  Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong
             inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp];
             sensitive substrates of CYP3A4 with a narrow therapeutic index)