An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

  • End date
    Sep 11, 2023
  • participants needed
  • sponsor
Updated on 29 January 2021
AstraZeneca Clinical Study Information Center
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The present study D5272C00001 (Legacy # 3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.

Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Placebo, Vedolizumab, Brazikumab
Clinical Study IdentifierNCT04718818
Last Modified on29 January 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of UC for at least 3 months
Inadequate response or intolerance to conventional therapy for the treatment of ulcerative colitis
Evidence of active UC based on the modified Mayo score
No known history of active TB
Agree to practicing abstinence or adhering to specific birth control requirements

Exclusion Criteria

Participant has UC limited to the rectum
History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitis specific complication of UC, including toxic megacolon
Previous intolerance or non-response to vedolizumab
Participants receiving exclusionary treatment within specified time periods
History of cancer, except for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
Clinically significant infections
Clinically significant cardiovascular conditions
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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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