An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

1. Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period.
2. Aged 18 to 80 years of age, inclusive, at screening.
3. Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
4. Evidence of UC extending proximal to the rectum (= 15 cm of involved colon).
5. Moderately to severely active UC as defined by Stool Frequency and Rectal Bleeding subscores and Modified Mayo endoscopic subscore.
6. Participant had an inadequate, failed response, or intolerance to intervention with oral corticosteroids, azathioprine, methotrexate, or 6-mercaptopurine, or demonstrated corticosteroid dependence for the treatment of ulcerative colitis.
7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 acceptable methods of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

1. Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge)
2. History of fulminant colitis, a diagnosis of Crohn’s disease or indeterminate colitis, presence or history of a fistula consistent with Crohn’s disease, primary sclerosing cholangitis, celiac disease, or bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening.
3. History of subtotal colectomy with ileorectostomy or colectomy with ileonal 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:
- Infliximab: within 8 weeks prior to Baseline (Visit 2)
- Adalimumab, certolizumab pegol, or golimumab: within 10 weeks prior to Baseline (Visit 2)
- Vedolizumab within 18 weeks prior to Baseline (Visit 2)
- Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to Baseline (Visit 2)
5. Participant has previously received vedolizumab, and was intolerant to intervention or
had met the criteria for primary or secondary non-response to intervention.

6. Participant is pregnant, breastfeeding, or plans to become pregnant during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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