Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)

  • Autoimmune Disorder
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Cities
  • Balatonfüred
  • Budapest
  • Chișinău
  • Dmytrivka
  • Jacksonville
  • Kyiv
  • T'bilisi
  • Tbilisi
Trial Identifier:

NCT03943550 WP40161

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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

      The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03943550,WP40161 Trial Identifier
      RO7049665, Placebo Treatments
      Ulcerative Colitis Condition
      Official Title

      A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis

      Eligibility criteria

      All Gender
      ≥18 Years & ≤ 70 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosed with UC for at least 12 weeks prior to screening
      • Screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years
      • Evidence of disease activity at time of screening
      • Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC
      Exclusion Criteria
      • Diagnosis of Crohn's disease or indeterminate colitis
      • History of infection with hepatitis B, human immunodeficiency virus (HIV), active hepatitis C virus (HCV) infection, or other chronic infection
      • Active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before Day -1
      • History of primary or acquired immunodeficiency
      • Abnormal hematologic values
      • Abnormal hepatic enzyme or hepatic function values

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