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



Status:Recruiting
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/21/2019
Start Date:August 7, 2018
End Date:February 14, 2021
Contact:Clinical Trials Registry Team
Email:IR‐CTRegistration@Allergan.com
Phone:877‐277‐8566

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A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

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.


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
We found this trial at
46
sites
611 North 35th Street
Morehead City, North Carolina 28557
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
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Albuquerque, New Mexico 87108
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Amarillo, Texas 79106
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Amarillo, TX
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Astoria, New York 11104
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Astoria, NY
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Baton Rouge, Louisiana 70809
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Biloxi, Mississippi 39531
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Biloxi, MS
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Boca Raton, Florida 33487
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Brooklyn, New York 11230
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Brownsburg, Indiana 46112
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Brownsburg, IN
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Camarillo, California 93012
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Camarillo, CA
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Carrollton, Texas 75007
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Chula Vista, California 91911
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Chula Vista, CA
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Cincinnati, OH
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Clearwater, Florida 33756
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Clearwater, FL
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Cutler Bay, Florida 33157
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Cutler Bay, FL
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Cutler Bay, Florida 33189
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Edmonton, Alberta
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Edmonton,
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12772 Valley View Street
Garden Grove, California 92845
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Garden Grove, CA
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Gurnee, Illinois 60031
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Gurnee, IL
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8206 Northwest 103rd Street
Hialeah, Florida 33016
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Hialeah, FL
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14903 El Camino Real
Houston, Texas 77062
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Houston, TX
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4671 South Congress Avenue
Lake Worth, Florida 33461
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Lake Worth, FL
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Lancaster, California 93534
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Lancaster, CA
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Las Vegas, Nevada 89106
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Little Rock, Arkansas 72212
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Los Angeles, California 90036
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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Marrero, LA
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3400 Southwest 107th Avenue
Miami, Florida 33165
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Miami, Florida 33157
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Miami, FL
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New Port Richey, Florida 34653
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New York, New York 10024
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Norman, Oklahoma 73069
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Norman, OK
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Poway, California 92064
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Poway, CA
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Richmond, Virginia
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Richmond, VA
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San Bernardino, California 92408
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San Diego, California 92103
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San Diego, California 92117
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San Diego, California 92114
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San Pablo, California 94806
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Tampa, Florida 33626
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Topeka, Kansas 66614
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Tucson, Arizona 85710
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Wayne, California 95648
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Wayne, CA
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