Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Key facts

Study ID

NCT02611817

Run by

Takeda

People needed

644

Starts

2016-01-04

Expected to finish

2019-08-06

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 CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
• Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of the following:
• C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L) OR
• Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
• Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
• CD involvement of the ileum and/or colon, at a minimum.
• 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 at Screening.
• Extensive colonic resection, subtotal or total colectomy.
• History of >3 small bowel resections or diagnosis of short bowel syndrome.
• Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
• Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, 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 CD required at any time during the study.
• History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
• Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
• Active infections.
• Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (that is, 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, or neurodegenerative disease.

Where it is running

• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Middlesex Gastroenterology Associates — Middletown, Connecticut, United States
• Nature Coast Clinical Research, LLC — Inverness, 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
• Grand Teton Research Group, PLL — Idaho Falls, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Tri-State Gastroenterology Associates — Crestview Hills, Kentucky, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, 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
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Ehrhardt Clinical Research, LLC — Belton, Missouri, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Gastro-Enterology Research of Lima — Lima, Ohio, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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