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

  • STATUS
    Recruiting
  • End date
    Feb 5, 2023
  • participants needed
    240
  • sponsor
    Pfizer
Updated on 3 August 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC (0.0 mi away) Contact
+248 other location

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.

Details
Condition Moderate to Severe Ulcerative Colitis
Treatment 50 mg, 450 mg, 150 mg, 0 mg
Clinical Study IdentifierNCT04090411
SponsorPfizer
Last Modified on3 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A diagnosis of UC for 3 months
Participants with moderate to severe active UC as defined by a Total Mayo Score of
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, antiIL -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
-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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