Phase
Condition
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Treatment
Adalimumab
Vedolizumab
Ustekinumab
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part A:
Has a confirmed diagnosis of CD at least 3 months before screening, based onendoscopy results.
Has moderately to severely active CD at Screening, defined as an SES-CD >=6 (>=4 ifisolated ileal disease).
Has demonstrated at least 1 of the following (a, b, or c) to at least 1 ILantagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approvedfor the treatment of CD:
Inadequate response after completing the full induction regimen;
Loss of response (recurrence of symptoms during scheduled maintenance dosingafter prior clinical benefit); or
Intolerance (a significant adverse event that precluded further use, includingbut not limited to serious infection including opportunistic infections,malignancy, infusion-related and hypersensitivity reactions includinganaphylaxis, and liver injury). Note: Participants with an inadequate response to >2 classes of advanced therapiesor >1 agent in the same class are not eligible. Participants who discontinued athird class of advanced therapy for reasons other than inadequate response may beeligible after discussion with the Medical Monitor. Part B:
In the investigator's opinion, the participant exhibits a therapeutic benefit atWeek 26.
Exclusion
Exclusion Criteria:
CDAI score > 450.
A current diagnosis of ulcerative colitis or indeterminate colitis.
Clinical evidence of an abdominal abscess.
Known fistula (other than perianal fistula) or phlegmon.
Known perianal fistula with abscess.
Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
Previous extensive bowel resection with 2 entire segments missing, of the following:terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
Short bowel syndrome.
Any planned surgical intervention for CD, except for seton placement for perianalfistula without abscess.
History or evidence of adenomatous colonic polyps that have not been removed.
History or evidence of colonic mucosal dysplasia.
Intolerance or contraindication to ileocolonoscopy.
Any identified congenital or acquired immunodeficiency (eg, common variableimmunodeficiency infection).
Active or latent tuberculosis (TB), regardless of treatment history.
A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitisB surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.
A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis Cvirus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).
Received approved or investigational anti-integrin antibodies (i.e., vedolizumab,natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181], anti- mucosal addressincell adhesion molecule-1 [MAdCAM-1] antibodies, or rituximab) for the treatment ofCD.
History of or symptoms of progressive multifocal leukoencephalopathy (PML) in theinvestigator's opinion. If a participant has symptoms consistent with PML, a PMLchecklist must be completed and submitted to the PML independent adjudicationcommittee. If the PML IAC deems the participant to have PML, the participant isineligible.
Study Design
Study Description
Connect with a study center
Covenant Health
Edmonton, Alberta T5K 2K4
CanadaActive - Recruiting
Covenant Health
Edmonton 5946768, Alberta 5883102 T5K 2K4
CanadaSite Not Available
London Health Sciences Centre
London, Ontario N6A 5A5
CanadaActive - Recruiting
West GTA Endoscopy Inc.
Mississauga, Ontario L5M 7N4
CanadaActive - Recruiting
Viable Clinical Research - North Bay
North Bay, Ontario P1B 2H3
CanadaActive - Recruiting
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
North York, Ontario M6A3B4
CanadaActive - Recruiting
ABP Research Services Corp.
Oakville, Ontario L6L 5L7
CanadaActive - Recruiting
Taunton Surgical Centre
Oshawa, Ontario L1J 0C7
CanadaSite Not Available
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan, Ontario L4L 4Y7
CanadaActive - Recruiting
Toronto Digestive Disease Associates (TDDA) Specialty Research
Vaughan, Ontario L4L 4Y7
CanadaSite Not Available
London Health Sciences Centre
London 6058560, Ontario 6093943 N6A 5A5
CanadaSite Not Available
West GTA Endoscopy Inc.
Mississauga 6075357, Ontario 6093943 L5M 7N4
CanadaSite Not Available
Viable Clinical Research - North Bay
North Bay 6089426, Ontario 6093943 P1B 2H3
CanadaSite Not Available
ABP Research Services Corp.
Oakville 6092122, Ontario 6093943 L6L 5L7
CanadaSite Not Available
Taunton Surgical Centre
Oshawa 6094578, Ontario 6093943 L1J 0C7
CanadaSite Not Available
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan 6173577, Ontario 6093943 L4L 4Y7
CanadaSite Not Available
Toronto Digestive Disease Associates (TDDA) Specialty Research
Vaughan 6173577, Ontario 6093943 L4L 4Y7
CanadaActive - Recruiting
McGill University Health Centre Montreal General Hospital
Montreal, Quebec H3G 1A4
CanadaSite Not Available
The Research Institute of the McGill University Health Centre
Montreal, Quebec H3G 1A4
CanadaActive - Recruiting
McGill University Health Centre Montreal General Hospital
Montreal 6077243, Quebec 6115047 H3G 1A4
CanadaSite Not Available
The Research Institute of the McGill University Health Centre
Montreal 6077243, Quebec 6115047 H3G 1A4
CanadaSite Not Available
Digestive Health Specialsits
Dothan, Alabama 36301
United StatesActive - Recruiting
Digestive Health Specialsits
Dothan 4059102, Alabama 4829764 36301
United StatesSite Not Available
GI Alliance Sun City
Sun City, Arizona 85351
United StatesActive - Recruiting
GI Alliance Sun City
Sun City 5316201, Arizona 5551752 85351
United StatesSite Not Available
University of California San Diego Health (UCSD)
La Jolla, California 92037
United StatesActive - Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Hoag Hospital Newport Beach
Newport Beach, California 92663
United StatesActive - Recruiting
University of California San Diego Health (UCSD)
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Hoag Hospital Newport Beach
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
United StatesActive - Recruiting
Medical Research Center of Connecticut, LLC
Hamden 4835654, Connecticut 4831725 06518
United StatesSite Not Available
Clinical Research of Osceola
Kissimmee, Florida 34741
United StatesActive - Recruiting
Endoscopic Research Inc
Orlando, Florida 32803
United StatesActive - Recruiting
Alliance Clinical Research of Tampa, LLC
Tampa, Florida 33615
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Clinical Research of Osceola
Kissimmee 4160983, Florida 4155751 34741
United StatesSite Not Available
Endoscopic Research Inc
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Alliance Clinical Research of Tampa, LLC
Tampa 4174757, Florida 4155751 33615
United StatesActive - Recruiting
University of South Florida
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Gastroenterology Consultants, P.C.
Roswell, Georgia 30076
United StatesActive - Recruiting
Gastroenterology Consultants, P.C.
Roswell 4219934, Georgia 4197000 30076
United StatesSite Not Available
University of Chicago Medicine
Chicago, Illinois 60637
United StatesActive - Recruiting
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview, Illinois 60026
United StatesActive - Recruiting
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee, Illinois 60031
United StatesActive - Recruiting
University of Chicago Medicine
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
GI Alliance - Illinois Gastroenterology Group - Glenview
Glenview 4893886, Illinois 4896861 60026
United StatesSite Not Available
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Gurnee 4894861, Illinois 4896861 60031
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Cotton ONeil Clinical Research Center
Topeka, Kansas 66606
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Cotton ONeil Clinical Research Center
Topeka 4280539, Kansas 4273857 66606
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Louisville
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
GI Alliance
Metairie, Louisiana 70006
United StatesActive - Recruiting
Tulane University
New Orleans, Louisiana 70112
United StatesActive - Recruiting
GI Alliance
Metairie 4333177, Louisiana 4331987 70006
United StatesSite Not Available
Tulane University
New Orleans 4335045, Louisiana 4331987 70112
United StatesSite Not Available
Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan 48038
United StatesSite Not Available
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Huron Gastroenterology Associates, P.C.
Ypsilanti 5015688, Michigan 5001836 48197
United StatesSite Not Available
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri 64111
United StatesActive - Recruiting
BVL Clinical Research
Liberty, Missouri 64068
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Mid-America Gastro-Intestinal Consultants
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
BVL Clinical Research
Liberty 4395052, Missouri 4398678 64068
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Inflammatory Bowel Disease Center at NYU Langone
New York, New York 10016
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Wake Research Associates, LLC
Raleigh, North Carolina 27612
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45627
United StatesActive - Recruiting
Ohio Gastroenterology group, Inc.
Columbus, Ohio 43202
United StatesActive - Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United StatesActive - Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio 44145
United StatesActive - Recruiting
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45627
United StatesSite Not Available
Ohio Gastroenterology group, Inc.
Columbus 4509177, Ohio 5165418 43202
United StatesSite Not Available
Great Lakes Gastroenterology Research, LLC
Mentor 5162645, Ohio 5165418 44060
United StatesSite Not Available
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake 5176517, Ohio 5165418 44145
United StatesSite Not Available
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma 73114
United StatesActive - Recruiting
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma 73102
United StatesActive - Recruiting
Digestive Disease Specialists, Inc.
Oklahoma City 4544349, Oklahoma 4544379 73114
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Allegheny Health Network
Wexford, Pennsylvania 15090
United StatesActive - Recruiting
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Allegheny Health Network
Wexford 5219062, Pennsylvania 6254927 15090
United StatesSite Not Available
University Gastroenterology
Providence, Rhode Island 02905
United StatesActive - Recruiting
University Gastroenterology
Providence 5224151, Rhode Island 5224323 02905
United StatesSite Not Available
Rapid City Medical Center, LLP
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Rapid City Medical Center, LLP
Rapid City 5768233, South Dakota 5769223 57701
United StatesSite Not Available
Texas Digestive Disease Consultants Cedar Park
Cedar Park, Texas 78613
United StatesActive - Recruiting
GI Alliance - Digestive Health Associates of Texas
Dallas, Texas 75044
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
Texas Digestive Disease Consultants Lubbock
Lubbock, Texas 79410
United StatesActive - Recruiting
GI Alliance - Mansfield
Mansfield, Texas 76063
United StatesActive - Recruiting
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas 78229
United StatesActive - Recruiting
Southern Star Research Institute, LLC.
San Antonio, Texas 78229
United StatesActive - Recruiting
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas 76092
United StatesActive - Recruiting
Tyler Research Institute, LLC
Tyler, Texas 75701
United StatesActive - Recruiting
GI Alliance - Webster
Webster, Texas 77598
United StatesActive - Recruiting
Texas Digestive Disease Consultants Cedar Park
Cedar Park 4679867, Texas 4736286 78613
United StatesSite Not Available
GI Alliance - Digestive Health Associates of Texas
Dallas 4684888, Texas 4736286 75044
United StatesSite Not Available
The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Texas Digestive Disease Consultants Lubbock
Lubbock 5525577, Texas 4736286 79410
United StatesSite Not Available
GI Alliance - Mansfield
Mansfield 4709013, Texas 4736286 76063
United StatesSite Not Available
Gastroenterology Research of San Antonio, LLC
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
Southern Star Research Institute, LLC.
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake 4733313, Texas 4736286 76092
United StatesSite Not Available
Tyler Research Institute, LLC
Tyler 4738214, Texas 4736286 75701
United StatesSite Not Available
GI Alliance - Webster
Webster 4740423, Texas 4736286 77598
United StatesSite Not Available
University of Utah Health
Salt Lake City, Utah 84108
United StatesActive - Recruiting
University of Utah Health
Salt Lake City 5780993, Utah 5549030 84108
United StatesSite Not Available
Washington Gastroenterology- GIA
Bellevue, Washington 98004
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101-2756
United StatesSite Not Available
Washington Gastroenterology- GIA
Tacoma, Washington 98405
United StatesActive - Recruiting
Washington Gastroenterology- GIA
Bellevue 5786882, Washington 5815135 98004
United StatesSite Not Available
Washington Gastroenterology- GIA
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

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