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.

Dothan, Alabama

Status

Recruiting

Address

Digestive Health Specialist of the Southeast

Dothan, Alabama, 36305

Site Contact

+1-877-825-3327

Advanced Clinical Therapeutics, LLC, Tucson, Arizona

Status

Recruiting

Address

Advanced Clinical Therapeutics, LLC

Tucson, Arizona, 85712

Site Contact

+1-877-825-3327

Arkansas Primary Care Clinic, PA, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, 72204

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+1-877-825-3327

Care Access Research LLC, San Pablo, California

Status

Recruiting

Address

Care Access Research LLC

San Pablo, California, 94806

Site Contact

+1-877-825-3327

Care Access Research, San Pablo, San Pablo, California

Status

Recruiting

Address

Care Access Research, San Pablo

San Pablo, California, 94806

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+1-877-825-3327

Bridgeport, Connecticut

Status

Recruiting

Address

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06066

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+1-877-825-3327

Gastro Florida, Clearwater, Florida

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Recruiting

Address

Gastro Florida

Clearwater, Florida, 33756

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+1-877-825-3327

Florida Research Network, LLC, Gainesville, Florida

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Florida Research Network, LLC

Gainesville, Florida, 32605

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+1-877-825-3327

Wellness Clinical Research, LLC, Hialeah, Florida

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Recruiting

Address

Wellness Clinical Research, LLC

Hialeah, Florida, 33016

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+1-877-825-3327

Center for Advanced Gastro, Maitland, Florida

Status

Recruiting

Address

Center for Advanced Gastro

Maitland, Florida, 32751

Site Contact

+1-877-825-3327

Center for Interventional Endo, Orlando, Florida

Status

Recruiting

Address

Center for Interventional Endo

Orlando, Florida, 32803

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+1-877-825-3327

BRCR Medical Center, Inc., Pembroke Pines, Florida

Status

Recruiting

Address

BRCR Medical Center, Inc.

Pembroke Pines, Florida, 33028

Site Contact

+1-877-825-3327

Gastro Florida, Tampa, Florida

Status

Recruiting

Address

Gastro Florida

Tampa, Florida, 33626

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+1-877-825-3327

Atlanta Gastroenterology Specialists, PC, Atlanta, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia, 30308

Site Contact

+1-877-825-3327

Atlanta Center for Gastroenterology, Decatur, Georgia

Status

Recruiting

Address

Atlanta Center for Gastroenterology

Decatur, Georgia, 30033

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+1-877-825-3327

Grand Teton Research Group, PLLC, Idaho Falls, Idaho

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Recruiting

Address

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404

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+1-877-825-3327

University of Chicago Medical Center, Chicago, Illinois

Status

Recruiting

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

Site Contact

+1-877-825-3327

NorthShore University HealthSystem, Evanston, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem

Evanston, Illinois, 60201

Site Contact

+1-877-825-3327

Aquiant Research, New Albany, Indiana

Status

Recruiting

Address

Aquiant Research

New Albany, Indiana, 47150

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+1-877-825-3327

Iowa Digestive disease center, Clive, Iowa

Status

Recruiting

Address

Iowa Digestive disease center

Clive, Iowa, 50325

Site Contact

+1-877-825-3327

Cotton O'Neil Clinical Research Center, Topeka, Kansas

Status

Recruiting

Address

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66604

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+1-877-825-3327

Gastroenterology Associates LLC, Baton Rouge, Louisiana

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Recruiting

Address

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809

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+1-877-825-3327

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

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+1-877-825-3327

Johns Hopkins Clinical Research Center, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Clinical Research Center

Baltimore, Maryland, 21287

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+1-877-825-3327

Gastro Center of Maryland, Columbia, Maryland

Status

Recruiting

Address

Gastro Center of Maryland

Columbia, Maryland, 20721

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+1-877-825-3327

Oakland Medical Research Center, Troy, Michigan

Status

Recruiting

Address

Oakland Medical Research Center

Troy, Michigan, 48085

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+1-877-825-3327

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

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+1-877-825-3327

Las Vegas Medical Research, Las Vegas, Nevada

Status

Recruiting

Address

Las Vegas Medical Research

Las Vegas, Nevada, 89113

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+1-877-825-3327

Weill Cornell Medical College, New York, New York

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Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

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+1-877-825-3327

Charlotte, North Carolina

Status

Recruiting

Address

Charlotte Gastroenterology and Hepatology

Charlotte, North Carolina, 28207

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+1-877-825-3327

Dayton Gastroenterology, Inc, Dayton, Ohio

Status

Recruiting

Address

Dayton Gastroenterology, Inc

Dayton, Ohio, 45415

Site Contact

+1-877-825-3327

University of Pennsylvania Health System, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Site Contact

+1-877-825-3327

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

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+1-877-825-3327

Gastroenterology Associates PA, Greenville, South Carolina

Status

Recruiting

Address

Gastroenterology Associates PA

Greenville, South Carolina, 29615

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+1-877-825-3327

Midwest Medical Care, Sioux Falls, South Dakota

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Recruiting

Address

Midwest Medical Care

Sioux Falls, South Dakota, 57105

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+1-877-825-3327

Vanderbilt Medical Center, Nashville, Tennessee

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Address

Vanderbilt Medical Center

Nashville, Tennessee, 37212

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+1-877-825-3327

VA North Texas Health Care System, Dallas, Texas

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Recruiting

Address

VA North Texas Health Care System

Dallas, Texas, 75216

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+1-877-825-3327

Dallas, Texas

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Address

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, 75231

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+1-877-825-3327

Dallas, Texas

Status

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University of Texas Southwestern Medical Center

Dallas, Texas, 75390

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+1-877-825-3327

Ygenics, Decatur, Texas

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Ygenics

Decatur, Texas, 76234

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+1-877-825-3327

Baylor College of Medicine, Houston, Texas

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Baylor College of Medicine

Houston, Texas, 77030

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+1-877-825-3327

Texas Digestive Disease Consultants, Keller, Texas

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Texas Digestive Disease Consultants

Keller, Texas, 76248

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+1-877-825-3327

DHAT Research Institute, Richardson, Texas

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DHAT Research Institute

Richardson, Texas, 75082

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+1-877-825-3327

Southlake, Texas

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Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092

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+1-877-825-3327

BaylorScott&White Research Institute, Temple, Texas

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Address

BaylorScott&White Research Institute

Temple, Texas, 76508

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+1-877-825-3327

GI Liver Research LLC, Webster, Texas

Status

Recruiting

Address

GI Liver Research LLC

Webster, Texas, 77598

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+1-877-825-3327

Care Access Research, Salt Lake City, Utah

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Recruiting

Address

Care Access Research

Salt Lake City, Utah, 84124

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+1-877-825-3327

Fairfax, Virginia

Status

Recruiting

Address

Gastroenterology Associates of Northern Virginia, Ltd.

Fairfax, Virginia, 22031

Site Contact

+1-877-825-3327

McGuire Research Institute, Richmond, Virginia

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Recruiting

Address

McGuire Research Institute

Richmond, Virginia, 23249

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+1-877-825-3327

Swedish Medical Center, Seattle, Washington

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Recruiting

Address

Swedish Medical Center

Seattle, Washington, 98104

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+1-877-825-3327

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195

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+1-877-825-3327

Medical College of Wisconsin, Inc., Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53266

Site Contact

+1-877-825-3327

International Sites

South Edmonton Gastorenterology, Edmonton, Alberta, Canada

Status

Recruiting

Address

South Edmonton Gastorenterology

Edmonton, Alberta, T6L 6K3

Site Contact

+1-877-825-3327

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

Status

Recruiting

Address

PerCuro Clinical Research Ltd.

Victoria, British Columbia, V8V 3M9

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+1-877-825-3327

LHSC - University Hospital, London, Ontario, Canada

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Recruiting

Address

LHSC - University Hospital

London, Ontario, N6A 5A5

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+1-877-825-3327

LHSC - Victoria Hospital, London, Ontario, Canada

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LHSC - Victoria Hospital

London, Ontario, N6A 5W9

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+1-877-825-3327

Taunton Surgical Centre, Oshawa, Ontario, Canada

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Taunton Surgical Centre

Oshawa, Ontario, L1H 7K4

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+1-877-825-3327

Vaughan, Ontario, Canada

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Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, L4L4Y7

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+1-877-825-3327

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