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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
This protocol has two independent parts. In Part 1, participants will be randomized to one of three Tulisokibart arms of treatment or placebo. Tretment will include induction, maintenance, and extension. When the maximum number of participants with prior exposure to advanced therapies has been reached, Part 2 will open for enrollment. In Part 2, the participants will be randomized to one of two dosing arms of Tulisokibart or a placebo.
The participants will be required to sign the inform consent and understand the requirements. They must have in person visits, comply with the procedures (blood test), colonoscopy, and to complete daily dairy about their symptoms. They must provide specimens such as blood, stool, and urine.
$100 per completed visit, $250 per endoscopy
Individual of any sex/gender from 18 years to 75 years of age inclusive,
Has had disease more than 3 months and has moderately active disease with one of the standard therapies
Average daily very soft or liquid SF ≥4 and/or average daily APS ≥2 at Baseline.
Demostrates loss of response, intolerance or inadequate response to standard therapy
Has CD without colonic involvement
Has known colonic stricture or colonic stenosis
Has current stoma
Is missing more than two colonic segments or has short bowel syndrome