An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - 80
Updated:4/3/2019
Start Date:December 7, 2018
End Date:December 4, 2022
Contact:Clinical Trial Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:877-277-8566

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A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I)
and versus an active comparator (Stage 2) in participants with moderately to severely active
CD and will include assessments of clinical response as demonstrated by improvement of
symptoms and colonic mucosal appearance as observed on endoscopy


Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however,
participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.

Inclusion Criteria:

- Aged 16 to 80 years, inclusive, at Screening. For participants less than 18 years of
age, the participant must weigh at least 40 kg

- Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum
of 3 months prior to screening

- Moderately to severely active Crohn's Disease

Exclusion Criteria:

- Participant is unable or unwilling to have endoscopic procedures performed during the
study.

- History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic
colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis,
or untreated bile acid malabsorption.

- Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma
within 3 months prior to screening.

- Participant has known history of drug (including opiates) or alcohol abuse.

- Currently enrolled in another investigational device or drug study.

- Participant is pregnant, breastfeeding, or plans to become pregnant during the study.
We found this trial at
39
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New York, New York 10024
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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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Astoria, New York 11104
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Beachwood, Ohio 44122
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Boca Raton, Florida 33487
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Brooklyn, New York 11230
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Brownsburg, Indiana
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Camarillo, California 93012
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Carrollton, Texas 75007
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Chesterfield, Michigan 48098
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Chula Vista, California 91911
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Clearwater, Florida 33756
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Colorado Springs, Colorado 80907
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Cutler Bay, Florida 33189
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Gurnee, Illinois 60031
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8206 Northwest 103rd Street
Hialeah, Florida 33016
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14903 El Camino Real
Houston, Texas 77062
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Lancaster, California 93534
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Lincoln, California 95648
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Little Rock, Arkansas 72212
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Los Alamitos, California 90720
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Los Angeles, California 90067
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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Miami, Florida 33157
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611 North 35th Street
Morehead City, North Carolina 28557
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New Port Richey, Florida 34653
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Norman, Oklahoma 73069
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Oklahoma City, Oklahoma 73112
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Poway, California 92064
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Richmond, Virginia
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San Bernardino, California 92408
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San Diego, California 92103
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San Diego, California 92114
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Springfield, Ohio 45504
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Tampa, Florida 33626
Phone: 727-347-0536
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Topeka, Kansas 66614
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