A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

  • 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:

Completed

This trial runs in
Countries
  • Australia
  • Belgium
  • Bulgaria
  • Colombia
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Thailand
  • Türkiye
  • Ukraine
  • United Kingdom
  • United States
Trial Identifier:

NCT04090411 TL1A Tuscany 2 2019-002698-74 B7541007

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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 phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04090411, B7541007, TL1A,Tuscany 2,2019-002698-74 Trial Identifier
      Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, Induction- PF-06480605 450 mg SC Q4W, Induction- Placebo SC Q4W, Chronic- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W Treatments
      Moderate to Severe Ulcerative Colitis Condition
      Official Title

      A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis

      Eligibility Criteria

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

      Inclusion Criteria:-

      • A diagnosis of UC for ≥3 months.
      • Participants with moderate to severe active UC as defined by a Total Mayo Score of

      ≥6, and an endoscopic subscore of ≥2.

      • Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
      • Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.
      Exclusion Criteria
      • Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
      • Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
      • Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
      • 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
      • Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
      • Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

      For the latest version of this information please go to www.forpatients.roche.com

       

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