A 54-Week, Multicenter, Randomized, Double-blind, Placebo controlled, 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) - EXPEDITION LEAD-I

ASTRAZENECA AB0 sites0 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\) Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent
•2\) Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening
•3\) Evidence of UC extending proximal to the rectum
•4\) Moderately to severely active UC
•5\) Participant had an inadequate response or intolerance to intervention with conventional
•6\) Participant has no known history of active TB

•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 within12 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\.Participants who received IV or intramuscular steroids within 2 weeks prior to Screening
•5\.Except for ustekinumab, prior exposure to any biologic agent targeting IL\-12 or IL\-23
•6\.Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy
•7\.Participant has known or suspected history of chronic use of NSAIDs
•8\.Clinically significant cardiovascular conditions

Not specified