Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
Vedolizumab IV
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has a diagnosis of UC established at least 1 month prior to Screening by clinical andendoscopic evidence and corroborated by a histopathology report.
- Has moderately to severely active UC as determined by a complete Mayo score of 6 to 12with an endoscopic subscore ≥2 within 28 days prior to enrollment.
- Has evidence of UC proximal to the rectum (≥15 cm of involved colon) prior to start ofvedolizumab IV dosing.
- Has been determined to be suitable for vedolizumab IV for routine management of UC bytheir physician.
- Has a family history of colorectal cancer, personal history of increased colorectalcancer risk, age >50 years, or other known risk factor must be up-to-date oncolorectal cancer surveillance (may be performed during screening).
- Has demonstrated an inadequate response with, lost response to, or intolerance of atleast 1 of the following agents: immunomodulators, corticosteroids, or tumor necrosisfactor-alpha (TNF-α) antagonists. Subject who are naive to TNF-α antagonist therapy orwho have previously failed TNF-α antagonist therapy (including primary and secondarynon-responders or intolerant) may be included. Week 6 Randomized Treatment Period Inclusion Criteria
- Following Lead-in Period, the subject is assessed as having high vedolizumab drugclearance based on a predefined Week 5 serum vedolizumab concentration threshold (<50microg/mL).
- Following Lead-in Period, the subject is a non-responder based on partial Mayo scoreat Week 6.
Exclusion
Exclusion Criteria:
- Has clinical evidence of abdominal abscess or toxic megacolon at the Screening Visit.
- Has had an extensive colonic resection, subtotal or total colectomy.
- Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis,radiation colitis, diverticular disease associated with colitis, or microscopiccolitis.
- Has received any of the following for the treatment of underlying disease within 30days of screening:
- Non-biologic therapies (eg. cyclosporine, tacrolimus, thalidomide)
- An approved non-biologic therapy in an investigational protocol.
- Has received any investigational or approved biologic or biosimilar agent within 60days or 5 half-lives prior to screening (whichever is longer).
- Has previously had prior exposure to approved or investigational anti-integrinantibodies (e.g. natalizumab, efalizumab, etrolizumab, AMG-181, anti-MAdCAM-1antibodies or rituximab).
- Has previously received approved or investigational vedolizumab.
- The subject currently requires or is anticipated to require surgical intervention forUC during the study.
- Has history or evidence of adenomatous colonic polyps that have not been removed, orcolonic mucosal dysplasia.
- Has any evidence of an active infection during Screening (eg, sepsis, cytomegalovirus,or listeriosis).
- Has a clinically significant infection (eg, pneumonia, pyelonephritis) within 30 daysprior to screening, or ongoing chronic infection.
- Has evidence of active C. difficile as evidenced by positive C. difficile toxin or ishaving treatment for C. difficile infection or other intestinal pathogens duringScreening.
- Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or chronic HBV (HBV immune subjects (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included), orhepatitis C virus (HCV) infection. Subjects with documented successful treatment ofHCV with sustained virological response (SVR) at 26 weeks can be enrolled.
- Has active or latent tuberculosis (TB), as evidenced by the following: a. A diagnostic TB test performed within 30 days of screening or during the ScreeningPeriod that is positive, defined as: i. Positive QuantiFERON test or 2 successiveindeterminate QuantiFERON tests, OR ii. A TB skin test reaction ≥ 5 mm OR, b. ChestX-ray within 3 months of screening that is suspicious for pulmonary TB, and a positiveor 2 successive indeterminate QuantiFERON tests within 30 days prior to Screening orduring the Screening Period.
- Has any identified congenital or acquired immunodeficiency (eg, common variableimmunodeficiency, HIV infection, organ transplantation).
- Has any live vaccination within 30 days prior to Screening or is planning to receiveany live vaccination during participation in the study.
- Has used a topical (rectal) treatment with (5-ASA) or corticosteroidenemas/suppositories within 2 weeks prior to Screening.
- Has a history of hypersensitivity or allergies to vedolizumab IV or its components.
- Has received total parenteral nutrition (TPN) or albumin in the last 30 days prior toscreening.
- Has any unstable or uncontrolled cardiovascular disorder, heart failure moderate tosevere (New York Class Association III or IV), any pulmonary, hepatic, renal, GI,genitourinary, hematological, coagulation, immunological, endocrine/metabolic, orother medical disorder that, in the opinion of the investigator, would confound thestudy results or compromise subject safety.
- Has had a surgical procedure requiring general anesthesia within 30 days prior toscreening or is planning to undergo major surgery during the study period.
- Has a history of malignancy, except for the following: adequately-treatednon-metastatic basal cell skin cancer; squamous cell skin cancer that has beenadequately treated and that has not recurred for at least 1 year prior to Screening;and history of cervical carcinoma in situ that has been adequately treated and thathas not recurred for at least 3 years prior to screening. Subjects with remote historyof malignancy (eg, >10 years since completion of curative therapy without recurrence)will be considered based on the nature of the malignancy and the therapy received andmust be discussed with the sponsor on a case by-case basis prior to Screening.
- Has a history of any major neurological disorders, including stroke, multiplesclerosis, brain tumor, demyelinating, or neurodegenerative disease.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptomchecklist during Screening or prior to the administration of the first dose of studydrug on Day 1.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcoholabuse within 1 year prior to the Screening Visit.
Study Design
Study Description
Connect with a study center
South Edmonton Gastorenterology
Edmonton, Alberta T6L 6K3
CanadaSite Not Available
PerCuro Clinical Research Ltd.
Victoria, British Colombia V8V 3M9
CanadaSite Not Available
Brandon Medical Arts Clinic
Brandon, Manitoba R7A 0N7
CanadaSite Not Available
LHSC - University Hospital
London, Ontario N6A 5A5
CanadaSite Not Available
LHSC - Victoria Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
Taunton Surgical Centre
Oshawa, Ontario L1H 7K4
CanadaSite Not Available
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario L4L4Y7
CanadaSite Not Available
Digestive Health Specialist of the Southeast
Dothan, Alabama 36305
United StatesSite Not Available
IMC-Diagnostic& Medical Clinic
Mobile, Alabama 36604
United StatesSite Not Available
Digestive Health Research Unit
Scottsdale, Arizona 85251
United StatesSite Not Available
Advanced Clinical Therapeutics, LLC
Tucson, Arizona 85712
United StatesSite Not Available
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas 72204
United StatesSite Not Available
SC Clinical Research Inc
Garden Grove, California 92844
United StatesSite Not Available
Care Access Research LLC
San Pablo, California 94806
United StatesSite Not Available
Care Access Research, San Pablo
San Pablo, California 94806
United StatesSite Not Available
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut 06066
United StatesSite Not Available
Gastro Florida
Clearwater, Florida 33756
United StatesSite Not Available
Florida Research Network, LLC
Gainesville, Florida 32605
United StatesSite Not Available
Wellness Clinical Research, LLC
Hialeah, Florida 33016
United StatesSite Not Available
Sarkis Medical
Lake City, Florida 32055
United StatesSite Not Available
Center for Advanced Gastro
Maitland, Florida 32751
United StatesSite Not Available
Center for Interventional Endo
Orlando, Florida 32803
United StatesSite Not Available
BRCR Medical Center, Inc.
Pembroke Pines, Florida 33028
United StatesSite Not Available
Advanced Medical Research Center
Port Orange, Florida 32127
United StatesSite Not Available
Gastro Florida
Tampa, Florida 33626
United StatesSite Not Available
Atlanta Gastroenterology Specialists, PC
Atlanta, Georgia 30308
United StatesSite Not Available
Atlanta Center for Gastroenterology
Decatur, Georgia 30033
United StatesSite Not Available
Meridian Clinical Research, LLC
Savannah, Georgia 31406
United StatesSite Not Available
Grand Teton Research Group, PLLC
Idaho Falls, Idaho 83404
United StatesSite Not Available
Nortwstrn Feinberg Schl of Med
Chicago, Illinois 60611
United StatesSite Not Available
NorthShore University HealthSystem
Evanston, Illinois 60201
United StatesSite Not Available
Aquiant Research
New Albany, Indiana 47150
United StatesSite Not Available
Iowa Digestive disease center
Clive, Iowa 50325
United StatesSite Not Available
Cotton O'Neil Clinical Research Center
Topeka, Kansas 66604
United StatesSite Not Available
Gastroeneterology Associates of of Hazards
Hazard, Kentucky 41701
United StatesSite Not Available
Gastroenterology Associates LLC
Baton Rouge, Louisiana 70809
United StatesSite Not Available
3801 Houma Blvd. Ste 200
Metairie, Louisiana 70006
United StatesSite Not Available
Louisiana Research Center, LLC
Shreveport, Louisiana 71105
United StatesSite Not Available
4940 Eastern Ave A building
Baltimore, Maryland 21224
United StatesSite Not Available
Chevy Chase clinical research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Gastro Center of Maryland
Columbia, Maryland 20721
United StatesSite Not Available
Woodholme Gastroenterology Associates
Glen Burnie, Maryland 21061
United StatesSite Not Available
Oakland Medical Research Center
Troy, Michigan 48085
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Las Vegas Medical Research
Las Vegas, Nevada 89113
United StatesSite Not Available
Center for Digestive Health
Pennington, New Jersey 88534
United StatesSite Not Available
AccumetRx Research
Albuquerque, New Mexico 87109
United StatesSite Not Available
NYU Langone Long Island Clinic
Great Neck, New York 11021
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York 12601
United StatesSite Not Available
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina 28207
United StatesSite Not Available
Dayton Gastroenterology, Inc
Dayton, Ohio 45415
United StatesSite Not Available
University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Gastroenterology Associates PA
Greenville, South Carolina 29615
United StatesSite Not Available
Midwest Medical Care
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Vanderbilt Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
Aztec Medical Research LLC
Channelview, Texas 77530
United StatesSite Not Available
Texas Digestive Disease Consultants - Dallas
Dallas, Texas 75231
United StatesSite Not Available
Ygenics
Decatur, Texas 76234
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Texas Digestive Disease Consultants
Keller, Texas 76248
United StatesSite Not Available
DHAT Research Institute
Richardson, Texas 75082
United StatesSite Not Available
Texas Digestive Disease Consultants - Southlake
Southlake, Texas 76092
United StatesSite Not Available
BaylorScott&White Research Institute
Temple, Texas 76508
United StatesSite Not Available
GI Liver Research LLC
Webster, Texas 77598
United StatesSite Not Available
Care Access Research
Salt Lake City, Utah 84124
United StatesSite Not Available
Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320
United StatesSite Not Available
Gastroenterology Associates of Northern Virginia, Ltd.
Fairfax, Virginia 22031
United StatesSite Not Available
121 Nationwide Dr., Ste. A
Lynchburg, Virginia 24502
United StatesSite Not Available
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia 23502
United StatesSite Not Available
McGuire Research Institute
Richmond, Virginia 23249
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98104
United StatesSite Not Available
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin 53266
United StatesSite Not Available
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