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

  • STATUS
    Recruiting
  • End date
    Sep 11, 2023
  • participants needed
    225
  • sponsor
    AstraZeneca
Updated on 29 January 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (2.2 mi away) Contact
+67 other location

Summary

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.

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note