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
Chula Vista, California 91911
115
mi
from 91732
Chula Vista, CA
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
212
mi
from 91732
Las Vegas, NV
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Albuquerque, New Mexico 87108
653
mi
from 91732
Albuquerque, NM
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Amarillo, Texas 79106
922
mi
from 91732
Amarillo, TX
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Astoria, New York 11104
2436
mi
from 91732
Astoria, NY
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Beachwood, Ohio 44122
2041
mi
from 91732
Beachwood, OH
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Boca Raton, Florida 33487
2312
mi
from 91732
Boca Raton, FL
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Brooklyn, New York 11230
2186
mi
from 91732
Brooklyn, NY
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Brownsburg, Indiana
1780
mi
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Brownsburg, IN
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Camarillo, California 93012
59
mi
from 91732
Camarillo, CA
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Carrollton, Texas 75007
1217
mi
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Carrollton, TX
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Chesterfield, Michigan 48098
1963
mi
from 91732
Chesterfield, MI
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Clearwater, Florida 33756
2116
mi
from 91732
Clearwater, FL
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Colorado Springs, Colorado 80907
802
mi
from 91732
Colorado Springs, CO
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Cutler Bay, Florida 33189
2319
mi
from 91732
Cutler Bay, FL
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Gurnee, Illinois 60031
1721
mi
from 91732
Gurnee, IL
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8206 Northwest 103rd Street
Hialeah, Florida 33016
2311
mi
from 91732
Hialeah, FL
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14903 El Camino Real
Houston, Texas 77062
1375
mi
from 91732
Houston, TX
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Lancaster, California 93534
43
mi
from 91732
Lancaster, CA
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Lincoln, California 95648
380
mi
from 91732
Lincoln, CA
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Little Rock, Arkansas 72212
1463
mi
from 91732
Little Rock, AR
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Los Alamitos, California 90720
?
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Los Alamitos, CA
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Los Angeles, California 90067
22
mi
from 91732
Los Angeles, CA
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
1656
mi
from 91732
Marrero, LA
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Miami, Florida 33157
2322
mi
from 91732
Miami, FL
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2322
mi
from 91732
Miami, FL
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611 North 35th Street
Morehead City, North Carolina 28557
2335
mi
from 91732
Morehead City, NC
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New Port Richey, Florida 34653
2114
mi
from 91732
New Port Richey, FL
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New York, New York 10024
2351
mi
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New York, NY
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Norman, Oklahoma 73069
1169
mi
from 91732
Norman, OK
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Oklahoma City, Oklahoma 73112
1165
mi
from 91732
Oklahoma City, OK
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Poway, California 92064
95
mi
from 91732
Poway, CA
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Richmond, Virginia
2268
mi
from 91732
Richmond, VA
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San Bernardino, California 92408
41
mi
from 91732
San Bernardino, CA
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San Diego, California 92103
103
mi
from 91732
San Diego, CA
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San Diego, California 92114
106
mi
from 91732
San Diego, CA
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Springfield, Ohio 45504
1916
mi
from 91732
Springfield, OH
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Tampa, Florida 33626
Phone: 727-347-0536
2136
mi
from 91732
Tampa, FL
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Topeka, Kansas 66614
1282
mi
from 91732
Topeka, KS
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