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
sites
New Port Richey, Florida 34653
1091
mi
from
New Port Richey, FL
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
961
mi
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Las Vegas, NV
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Albuquerque, New Mexico 87108
520
mi
from
Albuquerque, NM
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Amarillo, Texas 79106
283
mi
from
Amarillo, TX
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Astoria, New York 11104
1290
mi
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Astoria, NY
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Beachwood, Ohio 44122
903
mi
from
Beachwood, OH
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Boca Raton, Florida 33487
1299
mi
from
Boca Raton, FL
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Brooklyn, New York 11230
1056
mi
from
Brooklyn, NY
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Brownsburg, Indiana
631
mi
from
Brownsburg, IN
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Camarillo, California 93012
1208
mi
from
Camarillo, CA
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Carrollton, Texas 75007
335
mi
from
Carrollton, TX
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Chesterfield, Michigan 48098
842
mi
from
Chesterfield, MI
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Chula Vista, California 91911
1140
mi
from
Chula Vista, CA
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Clearwater, Florida 33756
1100
mi
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Clearwater, FL
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Colorado Springs, Colorado 80907
386
mi
from
Colorado Springs, CO
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Cutler Bay, Florida 33189
1324
mi
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Cutler Bay, FL
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Gurnee, Illinois 60031
613
mi
from
Gurnee, IL
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8206 Northwest 103rd Street
Hialeah, Florida 33016
1310
mi
from
Hialeah, FL
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14903 El Camino Real
Houston, Texas 77062
585
mi
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Houston, TX
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Lancaster, California 93534
1149
mi
from
Lancaster, CA
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Lincoln, California 95648
1271
mi
from
Lincoln, CA
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Little Rock, Arkansas 72212
372
mi
from
Little Rock, AR
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Los Alamitos, California 90720
?
mi
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Los Alamitos, CA
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Los Angeles, California 90067
1177
mi
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Los Angeles, CA
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
700
mi
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Marrero, LA
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Miami, Florida 33157
1321
mi
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Miami, FL
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1321
mi
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Miami, FL
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611 North 35th Street
Morehead City, North Carolina 28557
1189
mi
from
Morehead City, NC
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New York, New York 10024
1225
mi
from
New York, NY
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Norman, Oklahoma 73069
175
mi
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Norman, OK
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Oklahoma City, Oklahoma 73112
158
mi
from
Oklahoma City, OK
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Poway, California 92064
1129
mi
from
Poway, CA
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Richmond, Virginia
1113
mi
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Richmond, VA
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San Bernardino, California 92408
1115
mi
from
San Bernardino, CA
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San Diego, California 92103
1142
mi
from
San Diego, CA
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San Diego, California 92114
1142
mi
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San Diego, CA
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Springfield, Ohio 45504
766
mi
from
Springfield, OH
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Tampa, Florida 33626
Phone: 727-347-0536
1117
mi
from
Tampa, FL
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Topeka, Kansas 66614
146
mi
from
Topeka, KS
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