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

Use our guide to learn which trials are right for you!

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
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
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...
?
mi
from
Weston, FL
Click here to add this to my saved trials
Anaheim, California 92805
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
425 Medical Drive
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Channelview, Texas 77530
?
mi
from
Channelview, TX
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
246 Clayton Road
Clayton, 3168
?
mi
from
Clayton,
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
8001 West 26th Avenue
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77084
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77079
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jackson Heights, New York 11372
?
mi
from
Jackson Heights, NY
Click here to add this to my saved trials
Kissimmee, Florida 34759
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lafayette, Louisiana 70503
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Miami, Florida 33180
?
mi
from
Miami, FL
Click here to add this to my saved trials
3001 Broadway Street Northeast
Minneapolis, Minnesota 55413
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
435 South Street
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana 70124
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Petersburg, Virginia 23805
?
mi
from
Petersburg, VA
Click here to add this to my saved trials
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Pratt, Kansas 67124
?
mi
from
Pratt, KS
Click here to add this to my saved trials
Providence, Rhode Island 02903
?
mi
from
Providence, RI
Click here to add this to my saved trials
Rialto, California 92377
?
mi
from
Rialto, CA
Click here to add this to my saved trials
Richardson, Texas 75082
?
mi
from
Richardson, TX
Click here to add this to my saved trials
Saginaw, Michigan 48603
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sayre, Pennsylvania 18840
?
mi
from
Sayre, PA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Southlake, Texas 76092
?
mi
from
Southlake, TX
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
5115 North Armenia Avenue
Tampa, Florida 33603
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Urbana, Illinois 61801
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Victoria, Texas 77904
?
mi
from
Victoria, TX
Click here to add this to my saved trials
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...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials