Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis

Study Purpose

The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in subjects with moderately to severely active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined serum vedolizumab concentration threshold less than (<) 50 microgram per milliliter (microg/mL) and who are Week 6 non-responders based on partial Mayo score.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Has a diagnosis of UC established at least 1 month prior to Screening by clinical and endoscopic evidence and corroborated by a histopathology report. 2. Has moderately to severely active UC as determined by a complete Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 28 days prior to enrollment. 3. Has evidence of UC proximal to the rectum (≥15 cm of involved colon) prior to start of vedolizumab IV dosing. 4. Has been determined to be suitable for vedolizumab IV for routine management of UC by their physician. 5. Has a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening). 6. Has demonstrated an inadequate response with, lost response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or tumor necrosis factor-alpha (TNF-α) antagonists. Subject who are naive to TNF-α antagonist therapy or who have previously failed TNF-α antagonist therapy (including primary and secondary non-responders or intolerant) may be included. Week 6 Randomized Treatment Period Inclusion Criteria 7. Following Lead-in Period, the subject is assessed as having high vedolizumab drug clearance based on a predefined Week 5 serum vedolizumab concentration threshold (<50 microg/mL). 8. Following Lead-in Period, the subject is a non-responder based on partial Mayo score at Week 6.

Exclusion Criteria:

1. Has clinical evidence of abdominal abscess or toxic megacolon at the Screening Visit. 2. Has had an extensive colonic resection, subtotal or total colectomy. 3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 5. Has received any of the following for the treatment of underlying disease within 30 days of screening: 1. Non-biologic therapies (eg. cyclosporine, tacrolimus, thalidomide) 2. An approved non-biologic therapy in an investigational protocol. 6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives prior to screening (whichever is longer). 7. Has previously had prior exposure to approved or investigational anti-integrin antibodies (e.g. natalizumab, efalizumab, etrolizumab, AMG-181, anti-MAdCAM-1 antibodies or rituximab). 8. Has previously received approved or investigational vedolizumab. 9. The subject currently requires or is anticipated to require surgical intervention for UC during the study. 10. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia. 11. Has any evidence of an active infection during Screening (eg, sepsis, cytomegalovirus, or listeriosis). 12. Has a clinically significant infection (eg, pneumonia, pyelonephritis) within 30 days prior to screening, or ongoing chronic infection. 13. Has evidence of active C. difficile as evidenced by positive C. difficile toxin or is having treatment for C. difficile infection or other intestinal pathogens during Screening. 14. 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), or hepatitis C virus (HCV) infection. Subjects with documented successful treatment of HCV with sustained virological response (SVR) at 26 weeks can be enrolled. 15. 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 Screening Period that is positive, defined as: i. Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR ii. A TB skin test reaction ≥ 5 mm OR, b. Chest X-ray within 3 months of screening that is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON tests within 30 days prior to Screening or during the Screening Period. 16. Has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, HIV infection, organ transplantation). 17. Has any live vaccination within 30 days prior to Screening or is planning to receive any live vaccination during participation in the study. 18. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks prior to Screening. 19. Has a history of hypersensitivity or allergies to vedolizumab IV or its components. 20. Has received total parenteral nutrition (TPN) or albumin in the last 30 days prior to screening. 21. Has any unstable or uncontrolled cardiovascular disorder, heart failure moderate to severe (New York Class Association III or IV), any pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety. 22. Has had a surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study period. 23. Has a history of malignancy, except for the following: adequately-treated non-metastatic basal cell skin cancer; squamous cell skin cancer that has been adequately 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 that has not recurred for at least 3 years prior to screening. Subjects with remote history of 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 and must be discussed with the sponsor on a case by-case basis prior to Screening. 24. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease. 25. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of the first dose of study drug on Day 1. 26. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03029143

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Takeda

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Medical Director Clinical Science
Principal Investigator Affiliation Takeda

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Canada, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colitis, Ulcerative
Additional Details

The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered as an IV infusion. It is being tested in this study with new doses. This study will investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with standard dosing of vedolizumab IV, over a 30-week treatment period. The study will enroll approximately 250 moderately to severely active subjects with UC in order to randomize approximately 100 non-responder subjects with high vedolizumab drug clearance. Subjects will receive induction therapy of vedolizumab IV 300 mg on Day 1 and Week 2 (Lead-in Period). At Week 5, serum vedolizumab concentration will be measured. At Week 6, subjects will be assessed for clinical response based on partial Mayo score. Results of both Week 5 vedolizumab concentration and Week 6 clinical response will determine the treatment pathway. Those who are non-responders based on partial Mayo score at Week 6 and who are assessed as having high vedolizumab clearance, based on a predefined Week 5 serum vedolizumab concentration threshold (<50 microg/mL) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  • - Vedolizumab IV Standard Treatment - Vedolizumab IV Dose Optimized All randomized subjects will receive vedolizumab IV either 300 mg or 600 mg every 4 or 8 weeks.
This multi-center trial will be conducted in United States of America and Canada. The overall time to participate in this study is 56 weeks. Subjects will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long term follow-up safety survey.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical College of Wisconsin, Inc., Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53266

Swedish Medical Center, Seattle, Washington

Status

Recruiting

Address

Swedish Medical Center

Seattle, Washington, 98104

McGuire Research Institute, Richmond, Virginia

Status

Recruiting

Address

McGuire Research Institute

Richmond, Virginia, 23249

121 Nationwide Dr., Ste. A, Lynchburg, Virginia

Status

Recruiting

Address

121 Nationwide Dr., Ste. A

Lynchburg, Virginia, 24502

Fairfax, Virginia

Status

Recruiting

Address

Gastroenterology Associates of Northern Virginia, Ltd.

Fairfax, Virginia, 22031

Care Access Research, Salt Lake City, Utah

Status

Recruiting

Address

Care Access Research

Salt Lake City, Utah, 84124

GI Liver Research LLC, Webster, Texas

Status

Recruiting

Address

GI Liver Research LLC

Webster, Texas, 77598

BaylorScott&White Research Institute, Temple, Texas

Status

Recruiting

Address

BaylorScott&White Research Institute

Temple, Texas, 76508

Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092

DHAT Research Institute, Richardson, Texas

Status

Recruiting

Address

DHAT Research Institute

Richardson, Texas, 75082

Texas Digestive Disease Consultants, Keller, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

Keller, Texas, 76248

Baylor College of Medicine, Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Ygenics, Decatur, Texas

Status

Recruiting

Address

Ygenics

Decatur, Texas, 76234

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Dallas, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, 75231

Vanderbilt Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt Medical Center

Nashville, Tennessee, 37212

Midwest Medical Care, Sioux Falls, South Dakota

Status

Recruiting

Address

Midwest Medical Care

Sioux Falls, South Dakota, 57105

Gastroenterology Associates PA, Greenville, South Carolina

Status

Recruiting

Address

Gastroenterology Associates PA

Greenville, South Carolina, 29615

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

University of Pennsylvania Health System, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Dayton Gastroenterology, Inc, Dayton, Ohio

Status

Recruiting

Address

Dayton Gastroenterology, Inc

Dayton, Ohio, 45415

Charlotte, North Carolina

Status

Recruiting

Address

Charlotte Gastroenterology and Hepatology

Charlotte, North Carolina, 28207

Poughkeepsie, New York

Status

Recruiting

Address

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601

Weill Cornell Medical College, New York, New York

Status

Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

Center for Digestive Health, Pennington, New Jersey

Status

Recruiting

Address

Center for Digestive Health

Pennington, New Jersey, 08534

Las Vegas Medical Research, Las Vegas, Nevada

Status

Recruiting

Address

Las Vegas Medical Research

Las Vegas, Nevada, 89113

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Oakland Medical Research Center, Troy, Michigan

Status

Recruiting

Address

Oakland Medical Research Center

Troy, Michigan, 48085

Woodholme Gastroenterology Associates, Glen Burnie, Maryland

Status

Recruiting

Address

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, 21061

Gastro Center of Maryland, Columbia, Maryland

Status

Recruiting

Address

Gastro Center of Maryland

Columbia, Maryland, 20721

Chevy Chase clinical research, Chevy Chase, Maryland

Status

Recruiting

Address

Chevy Chase clinical research

Chevy Chase, Maryland, 20815

4940 Eastern Ave A building, Baltimore, Maryland

Status

Recruiting

Address

4940 Eastern Ave A building

Baltimore, Maryland, 21224

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

3801 Houma Blvd. Ste 200, Metairie, Louisiana

Status

Recruiting

Address

3801 Houma Blvd. Ste 200

Metairie, Louisiana, 70006

Gastroenterology Associates LLC, Baton Rouge, Louisiana

Status

Recruiting

Address

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809

Cotton O'Neil Clinical Research Center, Topeka, Kansas

Status

Recruiting

Address

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66604

Iowa Digestive disease center, Clive, Iowa

Status

Recruiting

Address

Iowa Digestive disease center

Clive, Iowa, 50325

Aquiant Research, New Albany, Indiana

Status

Recruiting

Address

Aquiant Research

New Albany, Indiana, 47150

NorthShore University HealthSystem, Evanston, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem

Evanston, Illinois, 60201

University of Chicago Medical Center, Chicago, Illinois

Status

Recruiting

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

Nortwstrn Feinberg Schl of Med, Chicago, Illinois

Status

Recruiting

Address

Nortwstrn Feinberg Schl of Med

Chicago, Illinois, 60611

Grand Teton Research Group, PLLC, Idaho Falls, Idaho

Status

Recruiting

Address

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404

Atlanta Center for Gastroenterology, Decatur, Georgia

Status

Recruiting

Address

Atlanta Center for Gastroenterology

Decatur, Georgia, 30033

Atlanta Gastroenterology Specialists, PC, Atlanta, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia, 30308

Gastro Florida, Tampa, Florida

Status

Recruiting

Address

Gastro Florida

Tampa, Florida, 33626

Florida Hospital Physician's Group, Tampa, Florida

Status

Recruiting

Address

Florida Hospital Physician's Group

Tampa, Florida, 33613

BRCR Medical Center, Inc., Pembroke Pines, Florida

Status

Recruiting

Address

BRCR Medical Center, Inc.

Pembroke Pines, Florida, 33028

Center for Interventional Endo, Orlando, Florida

Status

Recruiting

Address

Center for Interventional Endo

Orlando, Florida, 32803

Center for Advanced Gastro, Maitland, Florida

Status

Recruiting

Address

Center for Advanced Gastro

Maitland, Florida, 32751

Wellness Clinical Research, LLC, Hialeah, Florida

Status

Recruiting

Address

Wellness Clinical Research, LLC

Hialeah, Florida, 33016

Florida Research Network, LLC, Gainesville, Florida

Status

Recruiting

Address

Florida Research Network, LLC

Gainesville, Florida, 32605

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33756

Bridgeport, Connecticut

Status

Recruiting

Address

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06066

Care Access Research, San Pablo, San Pablo, California

Status

Recruiting

Address

Care Access Research, San Pablo

San Pablo, California, 94806

Care Access Research LLC, San Pablo, California

Status

Recruiting

Address

Care Access Research LLC

San Pablo, California, 94806

Arkansas Primary Care Clinic, PA, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, 72204

Advanced Clinical Therapeutics, LLC, Tucson, Arizona

Status

Recruiting

Address

Advanced Clinical Therapeutics, LLC

Tucson, Arizona, 85712

Dothan, Alabama

Status

Recruiting

Address

Digestive Health Specialist of the Southeast

Dothan, Alabama, 36305

International Sites

Vaughan, Ontario, Canada

Status

Recruiting

Address

Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, L4L4Y7

Taunton Surgical Centre, Oshawa, Ontario, Canada

Status

Recruiting

Address

Taunton Surgical Centre

Oshawa, Ontario, L1H 7K4

LHSC - Victoria Hospital, London, Ontario, Canada

Status

Recruiting

Address

LHSC - Victoria Hospital

London, Ontario, N6A 5W9

LHSC - University Hospital, London, Ontario, Canada

Status

Recruiting

Address

LHSC - University Hospital

London, Ontario, N6A 5A5

PerCuro Clinical Research Ltd., Victoria, British Columbia, Canada

Status

Recruiting

Address

PerCuro Clinical Research Ltd.

Victoria, British Columbia, V8V 3M9

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