Purpose

The present study (3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of UC for at least 3 months.
  • Inadequate response or intolerance to conventional therapy for the treatment of ulcerative colitis
  • Evidence of active UC based on the modified Mayo score
  • No known history of active TB
  • Agree to practicing abstinence or adhering to specific birth control requirements

Exclusion Criteria

  • Participant has UC limited to the rectum
  • History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitis specific complication of UC, including toxic megacolon
  • Previous intolerance or non-response to vedolizumab
  • Participants receiving exclusionary treatment within specified time periods
  • History of cancer, except for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix.
  • Clinically significant infections
  • Clinically significant cardiovascular conditions

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brazikumab Dose 1
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71
  • Drug: Brazikumab
    Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
Experimental
Brazikumab Dose 2
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
  • Drug: Brazikumab
    Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
Experimental
Brazikumab Dose 3
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
  • Drug: Brazikumab
    Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
Active Comparator
Vedolizumab
Intravenous vedolizumab on day 1, day 15, and day 43 followed by IV vedolizumab every 8 weeks beginning at day 99.
  • Drug: Vedolizumab
    Intravenous vedolizumab on day 1, day 15, and day 43 followed by Intravenous vedolizumab every 8 weeks beginning at day 99.
Placebo Comparator
Placebo
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning at day 71.
  • Drug: Placebo
    Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning at day 71.

Recruiting Locations

UT Health
Houston, Texas 77030
Contact:
713-500-6676

More Details

Status
Recruiting
Sponsor
Allergan

Study Contact

Clinical Trials Registry Team
877-277-8566
IR-CTRegistration@Allergan.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.