Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:August 25, 2016
End Date:March 11, 2022
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants
with moderately to severely active Crohn's disease.


Inclusion Criteria:

- Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration,
with colitis, ileitis, or ileocolitis, confirmed at any time in the past by
radiography, histology, and/or endoscopy

- A woman of childbearing potential must have a negative highly sensitive serum
(beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a
negative urine pregnancy test result at Week 0

- Adhere to the following requirements for concomitant medication for the treatment of
Crohn's disease, which are permitted provided that doses meeting these requirements
are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0),
unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral
corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day
(mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c)
Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional
immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or
Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and
at a stable dose for at least 4 weeks before baseline

- A participant who has had extensive colitis for greater than or equal to (>=) 8 years,
or disease limited to the left side of the colon for >= 12 years, must either have had
a colonoscopy to assess for the presence of dysplasia within 1 year before the first
administration of study agent or a colonoscopy to assess for the presence of
malignancy at the screening visit, with no evidence of malignancy

- Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index
(CDAI) score of >= 220 but <= 450

Exclusion Criteria:

- Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks
or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents
(example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or
eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received
Vedolizumab <16 weeks before the first administration of study drug

- Woman who is pregnant or planning pregnancy or is a man who plans to father while
randomized in the study or within 16 weeks after the last administration of study
agent

- Participants with certain complications of Crohn's disease that would make it hard to
assess response to study drug

- Participants with a history of or ongoing chronic or recurrent infectious disease

- Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23,
including but not limited to ustekinumab or briakinumab (ABT-874)
We found this trial at
65
sites
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
2320
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Miami, FL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
2101
mi
from 91732
Charlotte, NC
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2035
mi
from 91732
Cleveland, OH
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
2104
mi
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Gainesville, FL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1357
mi
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Houston, TX
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
2135
mi
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Jacksonville, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
1762
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Nashville, TN
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
2244
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
572
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Salt Lake City, UT
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
961
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701 West Morse Boulevard
Winter Park, Florida 32789
2184
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Asheville, North Carolina 28801
2002
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Athens, Georgia 30607
1967
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Athens, GA
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Boston, Massachusetts 02114
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Boston, MA
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39 Brewster Road
Bristol, Connecticut 06010
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2001 Oriental Boulevard
Brooklyn, New York 11235
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322 Rue Haute
Bruxelles, 1000
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Charlottesville, Virginia 22903
(434) 924-0311
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45220
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Cleveland, OH
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Columbia, Maryland 21045
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Columbia, South Carolina 29203
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370 Minorca Avenue
Coral Gables, Florida 33134
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599 West State Street
Doylestown, Pennsylvania 18901
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1301 Central Street
Evanston, Illinois 60201
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Fairfax, VA
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Gainesville, Florida 32605
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1000 Northern Boulevard
Great Neck, New York 11021
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Greenville, South Carolina 29615
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441-N American General Ctr
Hermitage, Tennessee 37076
1763
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1026 School Street
Houma, Louisiana 70360
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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1792
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Indianapolis, IN
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1000 West South Boulder Road
Lafayette, Colorado 80026
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1 Lakeshore Drive
Lake Charles, Louisiana 70601
1470
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10101 RidgeGate Parkway
Lone Tree, Colorado 80124
817
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Madison, Wisconsin 53715
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Marietta, Georgia 30060
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8370 West Flagler Street
Miami, Florida 33144
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Miramar, Florida 33025
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435 South Street
Morristown, New Jersey 07960
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New York, New York 10003
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New York, New York 10016
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New York, New York 10021
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Palmetto Bay, Florida
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Philadelphia, Pennsylvania 19104
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Richardson, Texas 75082
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Richmond, Virginia 23249
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Saint Augustine, Florida 32086
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San Antonio, Texas 78229
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325 9th Avenue
Seattle, Washington 98104
961
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Shreveport, Louisiana 71103
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Southlake, Texas 76092
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Stanford, California 94305
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Tyler, Texas 75701
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