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 |
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.
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
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Utah Research is a major component in the life of the U benefiting...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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8901 Rockville Pike
Bethesda, Maryland 20889
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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39 Brewster Road
Bristol, Connecticut 06010
Bristol, Connecticut 06010
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1000 Northern Boulevard
Great Neck, New York 11021
Great Neck, New York 11021
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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University of Louisville The University of Louisville is a state supported research university located in...
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435 South Street
Morristown, New Jersey 07960
Morristown, New Jersey 07960
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Florida Hospital Florida Hospital is one of the country
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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