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
2731
mi
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Miami, FL
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
882
mi
from 98109
Las Vegas, NV
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Albuquerque, New Mexico 87108
1187
mi
from 98109
Albuquerque, NM
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Amarillo, Texas 79106
1358
mi
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Amarillo, TX
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Astoria, New York 11104
2403
mi
from 98109
Astoria, NY
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Beachwood, Ohio 44122
2030
mi
from 98109
Beachwood, OH
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Boca Raton, Florida 33487
2708
mi
from 98109
Boca Raton, FL
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Brooklyn, New York 11230
2129
mi
from 98109
Brooklyn, NY
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Brownsburg, Indiana
1854
mi
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Brownsburg, IN
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Camarillo, California 93012
942
mi
from 98109
Camarillo, CA
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Carrollton, Texas 75007
1668
mi
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Carrollton, TX
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Chesterfield, Michigan 48098
1920
mi
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Chesterfield, MI
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Chula Vista, California 91911
1074
mi
from 98109
Chula Vista, CA
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Clearwater, Florida 33756
2511
mi
from 98109
Clearwater, FL
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Colorado Springs, Colorado 80907
1067
mi
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Colorado Springs, CO
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Cutler Bay, Florida 33189
2735
mi
from 98109
Cutler Bay, FL
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Gurnee, Illinois 60031
1706
mi
from 98109
Gurnee, IL
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8206 Northwest 103rd Street
Hialeah, Florida 33016
2721
mi
from 98109
Hialeah, FL
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14903 El Camino Real
Houston, Texas 77062
1909
mi
from 98109
Houston, TX
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Lancaster, California 93534
919
mi
from 98109
Lancaster, CA
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Lincoln, California 95648
605
mi
from 98109
Lincoln, CA
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Little Rock, Arkansas 72212
1782
mi
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Little Rock, AR
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Los Alamitos, California 90720
?
mi
from 98109
Los Alamitos, CA
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Los Angeles, California 90067
959
mi
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Los Angeles, CA
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
2101
mi
from 98109
Marrero, LA
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Miami, Florida 33157
2731
mi
from 98109
Miami, FL
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611 North 35th Street
Morehead City, North Carolina 28557
2490
mi
from 98109
Morehead City, NC
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New Port Richey, Florida 34653
2501
mi
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New Port Richey, FL
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New York, New York 10024
2262
mi
from 98109
New York, NY
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Norman, Oklahoma 73069
1537
mi
from 98109
Norman, OK
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Oklahoma City, Oklahoma 73112
1523
mi
from 98109
Oklahoma City, OK
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Poway, California 92064
1050
mi
from 98109
Poway, CA
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Richmond, Virginia
2351
mi
from 98109
Richmond, VA
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San Bernardino, California 92408
970
mi
from 98109
San Bernardino, CA
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San Diego, California 92103
1063
mi
from 98109
San Diego, CA
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San Diego, California 92114
1065
mi
from 98109
San Diego, CA
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Springfield, Ohio 45504
1970
mi
from 98109
Springfield, OH
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Tampa, Florida 33626
Phone: 727-347-0536
2527
mi
from 98109
Tampa, FL
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Topeka, Kansas 66614
1456
mi
from 98109
Topeka, KS
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