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) - Phase 2 Dose-finding UC Study

AstraZeneca AB0 sites255 target enrollmentMay 5, 2020

Overview

No summary available.

Registry

who.int

Start Date

May 5, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Ability to provide informed consent prior to any study procedures and willing and able to attend all study visits.
•2\.Aged 18 to 80 years of age at the time of signing the informed consent.
•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).
•5\.Moderately to severely active UC as defined by (5a and 5b must be met):
•(a) Stool Frequency and Rectal Bleeding subscores will be obtained during Screening on an eDiary. The following criteria must also be met:
•i. Average daily mMS Stool Frequency subscore \= 1 AND
•ii. Average daily mMS Rectal Bleeding subscore \= 1
•(b) Modified Mayo endoscopic subscore of \= 2 based on a full colonoscopy within 14 days prior to initial IRT randomization.
•6\.Participant had an inadequate response or intolerance to intervention with conventional treatment (oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6 mercaptopurine) 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.

•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\.Except for ustekinumab, prior exposure to any biologic agent targeting IL\-12 or IL\-23 (risankizumab, brazikumab, mirikizumab, guselkumab, tildrakizumab).