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

Last updated: January 19, 2021
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Ulcerative Colitis

Crohn's Disease

Ulcers

Treatment

N/A

Clinical Study ID

NCT04718818
D5272C00001
2018-001605-93
  • Ages 18-80
  • All Genders

Study Summary

The present study D5272C00001 (Legacy # 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of UC for at least 3 months.
  • Inadequate response or intolerance to conventional therapy for the treatment ofulcerative 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

Exclusion Criteria:

  • Participant has UC limited to the rectum
  • History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitisspecific 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, orcarcinoma in situ of the cervix.
  • Clinically significant infections
  • Clinically significant cardiovascular conditions

Study Design

Total Participants: 225
Study Start date:
August 07, 2018
Estimated Completion Date:
September 11, 2023

Connect with a study center

  • Research Site

    Vaughan, Ontario L4L 4Y7
    Canada

    Suspended

  • Research Site

    Ahemdabad, 380054
    India

    Site Not Available

  • Research Site

    Bangalore, 560054
    India

    Site Not Available

  • Research Site

    Hyderabad, 500032
    India

    Site Not Available

  • Research Site

    Jaipur, 302004
    India

    Site Not Available

  • Research Site

    Nagpur, 440010
    India

    Site Not Available

  • Research Site

    New Delhi, 110017
    India

    Site Not Available

  • Research Site

    Rajkot, 360004
    India

    Site Not Available

  • Research Site

    Secunderabad, 500003
    India

    Site Not Available

  • Research Site

    Surat, 395002
    India

    Site Not Available

  • Research Site

    Wardha, 442004
    India

    Site Not Available

  • Research Site

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Research Site

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Research Site

    Wonju-si, 26426
    Korea, Republic of

    Site Not Available

  • Research Site

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Research Site

    Cluj Napoca, 400380
    Romania

    Site Not Available

  • Research Site

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 40201
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 114
    Taiwan

    Site Not Available

  • Research Site

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Research Site

    Little Rock, Arkansas 72212
    United States

    Active - Recruiting

  • Research Site

    Chula Vista, California 91911
    United States

    Active - Recruiting

  • Research Site

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Research Site

    Lincoln, California 95648
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90073
    United States

    Site Not Available

  • Research Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • Research Site

    Poway, California 92064
    United States

    Active - Recruiting

  • Research Site

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Research Site

    Clearwater, Florida 33621
    United States

    Active - Recruiting

  • Research Site

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Research Site

    Lakeland, Florida 33813
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Research Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Research Site

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • Research Site

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33626
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Research Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Research Site

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Research Site

    Brownsburg, Indiana 46112
    United States

    Active - Recruiting

  • Research Site

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • Research Site

    Shawnee Mission, Kansas 66226
    United States

    Active - Recruiting

  • Research Site

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Research Site

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Research Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Research Site

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Research Site

    Biloxi, Mississippi 39531
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89123
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    Sunnyside, New York 11104
    United States

    Active - Recruiting

  • Research Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Research Site

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Research Site

    Springfield, Ohio 45503
    United States

    Active - Recruiting

  • Research Site

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Research Site

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • Research Site

    Amarillo, Texas 79109
    United States

    Active - Recruiting

  • Research Site

    Carrollton, Texas 75007
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77017
    United States

    Active - Recruiting

  • Research Site

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Research Site

    Spring, Texas 77388
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23236
    United States

    Active - Recruiting

  • Research Site

    Seattle, Washington 98195
    United States

    Site Not Available

  • Research Site

    Spokane, Washington 99202
    United States

    Site Not Available

  • Research Site

    Huntington, West Virginia 25701
    United States

    Site Not Available

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