A Study of the Efficacy and Safety of Guselkumab 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:April 13, 2018
End Date:October 23, 2024
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this program is to evaluate the efficacy and safety of guselkumab in
participants with Crohn's disease.

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1)
and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and
efficacy of guselkumab dose regimens will be evaluated to support the selection of induction
and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who
complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term
extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety
will be assessed.

Inclusion Criteria:

- Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration
(defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed
at any time in the past by radiography, histology, and/or endoscopy

- Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal
pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)

- Have screening laboratory test results within the protocol specified parameters

- A female participant of childbearing potential must have a negative urine pregnancy
test result at screening and baseline

- Demonstrated intolerance or inadequate response to conventional or to biologic therapy
for CD

Exclusion Criteria:

- Current diagnosis of ulcerative colitis or indeterminate colitis

- Has complications of Crohn's disease, such as symptomatic strictures or stenoses,
short gut syndrome, or any other manifestation

- Unstable doses of concomitant Crohn's disease therapy

- Receipt of Crohn's disease approved biologic agents, investigational agents, or
procedures outside of permitted timeframe as specified in the protocol

- Prior exposure to p40 inhibitors or p19 inhibitors

- Any medical contraindications preventing study participation
We found this trial at
67
sites
New Orleans, Louisiana 70124
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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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...
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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...
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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...
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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...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Anaheim, California 92805
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Asheville, North Carolina 28801
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Atlanta, Georgia 30342
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Baton Rouge, Louisiana 70809
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425 Medical Drive
Bountiful, Utah 84010
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Channelview, Texas 77530
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Charleston, South Carolina 29406
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Charlottesville, Virginia 22903
(434) 924-0311
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Chesterfield, Michigan 48098
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246 Clayton Road
Clayton, 3168
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Columbus, OH
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Fayetteville, North Carolina 28304
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Fort Lauderdale, Florida 33308
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Greenville, North Carolina 27834
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8001 West 26th Avenue
Hialeah, Florida 33016
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Houston, Texas 77084
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Houston, Texas 77030
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Houston, Texas 77079
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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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Indianapolis, Indiana 46202
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Jackson Heights, New York 11372
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Kissimmee, Florida 34759
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Lafayette, Louisiana 70503
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Lancaster, California 93534
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Marietta, Georgia 30060
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Miami, Florida 33180
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3001 Broadway Street Northeast
Minneapolis, Minnesota 55413
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435 South Street
Morristown, New Jersey 07960
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New Orleans, Louisiana 70121
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New York, New York 10016
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Oklahoma City, Oklahoma 73112
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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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Petersburg, Virginia 23805
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Pinellas Park, Florida 33781
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Pratt, Kansas 67124
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Providence, Rhode Island 02903
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Rialto, California 92377
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Richardson, Texas 75082
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Saginaw, Michigan 48603
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San Antonio, Texas 78229
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Sayre, Pennsylvania 18840
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Shreveport, Louisiana 71103
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Southlake, Texas 76092
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Syracuse, New York 13210
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5115 North Armenia Avenue
Tampa, Florida 33603
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Tampa, Florida 33613
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tyler, TX
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Urbana, Illinois 61801
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Victoria, Texas 77904
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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