A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
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Lead
AbbVie
Age
16–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female aged \>=18 to \<= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
You may not be if
Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
Participant receiving prohibited medications and treatment.
Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
Participant with currently known complications of UC (e.g., megacolon).
No known active Coronavirus Disease - 2019 (COVID-19) infection.
Clareo Health | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
