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

Description

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.

Study Start Date

August, 25 2016

Estimated Completion Date

October 2020

Interventions

  • Drug: Placebo
  • Drug: Ustekinumab
  • Drug: JNJ-64304500

Study ID

Janssen Research & Development, LLC -- CR108136

Status

Recruiting

Trial ID

NCT02877134

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

450

Sponsor

Janssen Research & Development, LLC

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 enrolled 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)

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (180)

Study Location Distance Name Phone Email
Massachusetts General HospitalBoston - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalBoston - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalBoston - Boston, Massachusetts 2.8 miles None None None
Massachusetts General HospitalBoston - Boston, Massachusetts 2.8 miles None None None
Connecticut Gastroenterology Clinical Research Foundation - Bristol, Connecticut 105.6 miles None None None
Long Island Clinical Research AssociatesPeak Research LTD - Great Neck, New York 174.4 miles None None None
Long Island Clinical Research AssociatesPeak Research LTD - Great Neck, New York 174.4 miles None None None
Long Island Clinical Research AssociatesPeak Research LTD - Great Neck, New York 174.4 miles None None None
Long Island Clinical Research AssociatesPeak Research LTD - Great Neck, New York 174.4 miles None None None
Columbia University Medical Center - New York, New York 184.1 miles None None None
Columbia University Medical Center - New York, New York 184.1 miles None None None
Columbia University Medical Center - New York, New York 184.1 miles None None None
Weill Cornell Medical College - New York, New York 184.8 miles None None None
Weill Cornell Medical College - New York, New York 184.8 miles None None None
Weill Cornell Medical College - New York, New York 184.8 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
NY Scientific - Brooklyn, New York 192.5 miles None None None
NY Scientific - Brooklyn, New York 192.5 miles None None None
NY Scientific - Brooklyn, New York 192.5 miles None None None
Atlantic Digestive Health Institute Atlantic IBD Center - Morristown, New Jersey 206.4 miles None None None
Atlantic Digestive Health Institute Atlantic IBD Center - Morristown, New Jersey 206.4 miles None None None
Atlantic Digestive Health Institute Atlantic IBD Center - Morristown, New Jersey 206.4 miles None None None
Atlantic Digestive Health Institute Atlantic IBD Center - Morristown, New Jersey 206.4 miles None None None
Central Bucks SpecialistsGI - Doylestown, Pennsylvania 251.7 miles None None None
Central Bucks SpecialistsGI - Doylestown, Pennsylvania 251.7 miles None None None
Central Bucks SpecialistsGI - Doylestown, Pennsylvania 251.7 miles None None None
Central Bucks SpecialistsGI - Doylestown, Pennsylvania 251.7 miles None None None
Philadelphia VA Medical Center - Philadelphia, Pennsylvania 270.8 miles None None None
Philadelphia VA Medical Center - Philadelphia, Pennsylvania 270.8 miles None None None
Philadelphia VA Medical Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Gastro Center Of Maryland - Columbia, Maryland 371.5 miles None None None
Gastro Center Of Maryland - Columbia, Maryland 371.5 miles None None None
Gastro Center Of Maryland - Columbia, Maryland 371.5 miles None None None
Gastroenterology Associates of Northern Virginia - Fairfax, Virginia 404.7 miles None None None
Gastroenterology Associates of Northern Virginia - Fairfax, Virginia 404.7 miles None None None
Gastroenterology Associates of Northern Virginia - Fairfax, Virginia 404.7 miles None None None
McGuire Research Institute - Richmond, Virginia 477.2 miles None None None
McGuire Research Institute - Richmond, Virginia 477.2 miles None None None
McGuire Research Institute - Richmond, Virginia 477.2 miles None None None
University of Virginia - Charlottesville, Virginia 493.4 miles None None None
University of Virginia - Charlottesville, Virginia 493.4 miles None None None
University of Virginia - Charlottesville, Virginia 493.4 miles None None None
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles None None None
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles None None None
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Wake Research Associates - Raleigh, North Carolina 607.5 miles None None None
Wake Research Associates - Raleigh, North Carolina 607.5 miles None None None
Wake Research Associates - Raleigh, North Carolina 607.5 miles None None None
Carolinas GI Research - Raleigh, North Carolina 610.5 miles None None None
Carolinas GI Research - Raleigh, North Carolina 610.5 miles None None None
Carolinas GI Research - Raleigh, North Carolina 610.5 miles None None None
Carolinas GI Research - Raleigh, North Carolina 610.5 miles None None None
Center for Digestive Health - Troy, Michigan 616.5 miles None None None
Center for Digestive Health - Troy, Michigan 616.5 miles None None None
Center for Digestive Health - Troy, Michigan 616.5 miles None None None
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles None None None
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles None None None
Carolinas Medical Center - Charlotte, North Carolina 720.9 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati Hospital - Cincinnati, Ohio 737.6 miles None None None
Consultants for Clinical Research - Cincinnati, Ohio 737.9 miles None None None
Consultants for Clinical Research - Cincinnati, Ohio 737.9 miles None None None
Consultants for Clinical Research - Cincinnati, Ohio 737.9 miles None None None
Asheville Gastroenterology Associates - Asheville, North Carolina 773.5 miles None None None
Asheville Gastroenterology Associates - Asheville, North Carolina 773.5 miles None None None
Asheville Gastroenterology Associates - Asheville, North Carolina 773.5 miles None None None
Consultants in Gastroenterology - Columbia, South Carolina 786.3 miles None None None
Consultants in Gastroenterology - Columbia, South Carolina 786.3 miles None None None
Consultants in Gastroenterology - Columbia, South Carolina 786.3 miles None None None
Gastroenterology Associates PA - Greenville, South Carolina 797.4 miles None None None
Gastroenterology Associates PA - Greenville, South Carolina 797.4 miles None None None
Gastroenterology Associates PA - Greenville, South Carolina 797.4 miles None None None
Gastroenterology Associates PA - Greenville, South Carolina 797.4 miles None None None
Indianapolis Gastroenterology and Hepatology - Indianapolis, Indiana 804.9 miles None None None
Indianapolis Gastroenterology and Hepatology - Indianapolis, Indiana 804.9 miles None None None
Indianapolis Gastroenterology and Hepatology - Indianapolis, Indiana 804.9 miles None None None
University of Louisville - Louisville, Kentucky 823.2 miles None None None
University of Louisville - Louisville, Kentucky 823.2 miles None None None
University of Louisville - Louisville, Kentucky 823.2 miles None None None
Northshore Universite Healthsystem - Evanston, Illinois 850.4 miles None None None
Northshore Universite Healthsystem - Evanston, Illinois 850.4 miles None None None
Rush University Medical Center - Chicago, Illinois 851.3 miles None None None
Rush University Medical Center - Chicago, Illinois 851.3 miles None None None
Summit Clinical Research LLC - Athens, Georgia 885.0 miles None None None
Summit Clinical Research LLC - Athens, Georgia 885.0 miles None None None
Summit Clinical Research LLC - Athens, Georgia 885.0 miles None None None
Summit Clinical Research LLC - Athens, Georgia 885.0 miles None None None
Atlanta Gastroenterology Specialists PC - Suwanee, Georgia 909.1 miles None None None
Atlanta Gastroenterology Specialists PC - Suwanee, Georgia 909.1 miles None None None
Dean St Marys Outpatient Center - Madison, Wisconsin 930.4 miles None None None
Dean St Marys Outpatient Center - Madison, Wisconsin 930.4 miles None None None
Dean St Marys Outpatient Center - Madison, Wisconsin 930.4 miles None None None
Dean St Marys Outpatient Center - Madison, Wisconsin 930.4 miles None None None
AIG Research Services - Hermitage, Tennessee 932.8 miles None None None
AIG Research Services - Hermitage, Tennessee 932.8 miles None None None
AIG Research Services - Hermitage, Tennessee 932.8 miles None None None
Gastrointestinal Specialists of Georgia - Marietta, Georgia 933.9 miles None None None
Gastrointestinal Specialists of Georgia - Marietta, Georgia 933.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
East Coast Institute for Research - San Agustín, Florida 1,041.7 miles None None None
Florida Research Network LLC - Gainesville, Florida 1,080.1 miles None None None
Florida Research Network LLC - Gainesville, Florida 1,080.1 miles None None None
Florida Research Network LLC - Gainesville, Florida 1,080.1 miles None None None
Florida Research Network LLC - Gainesville, Florida 1,080.1 miles None None None
University of Florida - Gainesville, Florida 1,081.3 miles None None None
Shafran Gastroenterology Center - Winter Park, Florida 1,113.3 miles None None None
Florida Hospital - Orlando, Florida 1,115.8 miles None None None
FQL Research LLC - Miramar, Florida 1,248.1 miles None None None
University of Miami - Miami, Florida 1,259.8 miles None None None
Research Associates of South FloridaLLC - Coral Gables, Florida 1,263.4 miles None None None
Research Associates of South FloridaLLC - Coral Gables, Florida 1,263.4 miles None None None
Research Associates of South FloridaLLC - Coral Gables, Florida 1,263.4 miles None None None
Research Associates of South FloridaLLC - Coral Gables, Florida 1,263.4 miles None None None
A Research Inc - Miami, Florida 1,263.8 miles None None None
A Research Inc - Miami, Florida 1,263.8 miles None None None
A Research Inc - Miami, Florida 1,263.8 miles None None None
A Research Inc - Miami, Florida 1,263.8 miles None None None
IMIC Inc - Palmetto Bay, Florida 1,274.6 miles None None None
IMIC Inc - Palmetto Bay, Florida 1,274.6 miles None None None
IMIC Inc - Palmetto Bay, Florida 1,274.6 miles None None None
IMIC Inc - Palmetto Bay, Florida 1,274.6 miles None None None
Houma Digestive Health Specialists LLC - Houma, Louisiana 1,407.3 miles None None None
Houma Digestive Health Specialists LLC - Houma, Louisiana 1,407.3 miles None None None
Houma Digestive Health Specialists LLC - Houma, Louisiana 1,407.3 miles None None None
Louisiana Research Center LLC - Shreveport, Louisiana 1,415.9 miles None None None
Louisiana Research Center LLC - Shreveport, Louisiana 1,415.9 miles None None None
Louisiana Research Center LLC - Shreveport, Louisiana 1,415.9 miles None None None
Louisiana Research Center LLC - Shreveport, Louisiana 1,415.9 miles None None None
Clinical Trials of SWLA - Lake Charles, Louisiana 1,485.5 miles None None None
Clinical Trials of SWLA - Lake Charles, Louisiana 1,485.5 miles None None None
Clinical Trials of SWLA - Lake Charles, Louisiana 1,485.5 miles None None None
Digestive Health Specialists - Tyler, Texas 1,495.4 miles None None None
Digestive Health Specialists - Tyler, Texas 1,495.4 miles None None None
Digestive Health Specialists - Tyler, Texas 1,495.4 miles None None None
DHAT Research Institute - Richardson, Texas 1,537.4 miles None None None
DHAT Research Institute - Richardson, Texas 1,537.4 miles None None None
DHAT Research Institute - Richardson, Texas 1,537.4 miles None None None
Texas Digestive Disease Consultants - Southlake, Texas 1,562.1 miles None None None
Texas Digestive Disease Consultants - Southlake, Texas 1,562.1 miles None None None
Texas Digestive Disease Consultants - Southlake, Texas 1,562.1 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Houston Methodist Hospital - Houston, Texas 1,609.9 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Houston Methodist Hospital - Houston, Texas 1,609.9 miles None None None
Houston Methodist Hospital - Houston, Texas 1,609.9 miles None None None
South Denver PC - Lone Tree, Colorado 1,767.0 miles None None None
South Denver PC - Lone Tree, Colorado 1,767.0 miles None None None
South Denver PC - Lone Tree, Colorado 1,767.0 miles None None None
South Denver PC - Lone Tree, Colorado 1,767.0 miles None None None
Gastroenterology Research of America LLC - San Antonio, Texas 1,768.2 miles None None None
Gastroenterology Research of America LLC - San Antonio, Texas 1,768.2 miles None None None
Gastroenterology Research of America LLC - San Antonio, Texas 1,768.2 miles None None None
Gastroenterology Research of America LLC - San Antonio, Texas 1,768.2 miles None None None
University of Washington - Seattle, Washington 2,487.7 miles None None None
University of Washington - Seattle, Washington 2,487.7 miles None None None
University of Washington - Seattle, Washington 2,487.7 miles None None None
UWHarborview Medical Center - Seattle, Washington 2,489.6 miles None None None
UWHarborview Medical Center - Seattle, Washington 2,489.6 miles None None None
UWHarborview Medical Center - Seattle, Washington 2,489.6 miles None None None
UWHarborview Medical Center - Seattle, Washington 2,489.6 miles None None None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Stanford Hospital and Clinics - Stanford, California 2,694.5 miles None None None

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