A 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Expedition Lead-in

Ageishi Yuji0 sites21 target enrollmentAugust 30, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Ageishi Yuji

•1\. Ability to provide informed consent
•2\. Aged 18 to 80 years of age
•3\. Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening
•4\. Evidence of UC extending proximal to the rectum ( 15 cm of involved colon or more)
•5\. Moderately to severely active UC as defined by:
•a. Average daily mMS Stool Frequency subscore 1 or more AND Average daily mMS Rectal Bleeding subscore 1 or more.
•b. Modified Mayo endoscopic subscore of 2 or more based on a full colonoscopy within 14 days prior to randomization.
•6\. Participant had an inadequate response or intolerance to intervention with conventional treatment or prior biological treatment or demonstrated CS dependence for the treatment of UC. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.
•7\. Participants taking 5\-aminosalicylates, oral prednisone (or equivalent), oral budesonide, or immunomodulators must be at a stable dose or discontinued. Topical (rectal) aminosalicylic acid or topical (rectal) steroids should be discontinued.
•8\. Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control throughout the study and for at least 18 weeks after the last dose of study intervention.

•1\. Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
•2\. Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded.
•3\. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
•4\. Participant has received the following treatment:
•a. Infliximab: within 8 weeks prior to randomization.
•b. Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization.
•c. Vedolizumab or ustekinumab within 12 weeks of randomization.
•d. Other prohibited medication, biologic or small molecule treatment within 5 half\-lives prior to randomization.
•e. Fecal microbiota transplantation: within 8 weeks prior to randomization.
•5\. Criterion deleted as part of Amendment 5 v6\.0