A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome

  • Autoimmune Disorder
  • Sjogren's Syndrome
Please note that the recruitment status of the trial at your site may differ.
Trial Status:

Completed

This trial runs in
Cities
  • Ann Arbor
  • Baltimore
  • Baton Rouge
  • Berlin
  • Beverly Hills
  • Birmingham
  • Bobigny
  • Boulogne-Billancourt
  • Brest
  • Bydgoszcz
  • Cleveland
  • Denver
  • Duncansville
  • Durham
  • Lisboa
  • London
  • Memphis
  • Mineola
  • Montpellier
  • Newcastle upon Tyne
  • Pittsburgh
  • Porto
  • Poznań
  • Reading
  • Sheffield
  • Swindon
  • Warszawa
Trial Identifier:

NCT02701985 2015-004476-30 BP30037

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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).

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02701985,BP30037,2015-004476-30 Trial Identifier
      Placebo, RO5459072 Treatments
      Sjogren's Syndrome Condition
      Official Title

      A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      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)

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