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A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

  • Clinical Trial Information

    Trial Contact: Garcia de Djuro, Ginette

    Trial Phone: 321.841.6649

  • IRB No: W21.150.09

    Protocol Abbrev: Quasar

    Principal Investigator: Udayakumar Navaneethan, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CNTO1959UCO3001

    Treatment: IV Guselkumab

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04033445

  • Objective

    Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

  • Key Eligibility

    Documented diagnosis of ulcerative colitis (UC)
    Moderately to severely active UC, defined by modified Mayo score
    Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
    Screening laboratory test results within the parameters specified in the protocol