Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Key facts

Study ID

NCT02611830

Run by

Takeda

People needed

383

Starts

2015-12-18

Expected to finish

2018-08-21

Last updated by the study team

2022-05-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
• Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore ≥2)
• Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
• Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists

You may not qualify if…

• Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
• Extensive colonic resection, subtotal or total colectomy.
• Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
• Prior exposure to investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
• Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
• Prior exposure to vedolizumab
• Surgical intervention for UC required at any time during the study.
• History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia.
• Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
• Active infections
• Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection, HIV or tuberculosis (active or latent), identified congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included.
• History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.

Where it is running

• Rocky Mountain Clinical Research, LLC — Wheat Ridge, Colorado, United States
• Middlesex Gastroenterology Associates — Middletown, Connecticut, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• L & L Research Choices, Inc. — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Tri-State Gastroenterology Associates — Crestview Hills, Kentucky, United States
• Research Concierge, LLC — Owensboro, Kentucky, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Gastroenterology Associates of Western Michigan, P.L.C. — Wyoming, Michigan, United States
• Ehrhardt Clinical Research, LLC — Belton, Missouri, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States
• Premier Medical Group of the Hudson Valley, PC — Poughkeepsie, New York, United States
• Dayton Gastroenterology, Inc — Dayton, Ohio, United States
• Options Health Research — Tulsa, Oklahoma, United States
• Gastro One — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Arkansas Primary Care Clinic, PA — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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