A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Completed · Phase 3

Conditions studied: Colitis, Ulcerative

In brief

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

Key facts

Study ID: NCT04779307
Run by: Takeda
People needed: 121
Starts: 2021-10-19
Expected to finish: 2025-07-01
Last updated by the study team: 2026-04-30

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).
Weighs ≥10 kg at the time of screening and enrollment into the study.
Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.
Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.
Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
Has extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.

You may not qualify if…

Has previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
Has active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
Has received any live vaccinations within 30 days prior to first dose of study drug.
Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
Participants with a current diagnosis of indeterminate colitis.
Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.
Participant with active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening period that is positive, defined as:
Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
A TB skin test reaction ≥5 mm. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may, however, be included. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA). Note: Subjects who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks before baseline]).
The participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
Has positive stool studies for ova and/or parasites or stool culture at screening visit.
Has positive Clostridioides difficile (C difficile) stool test at screening visit.
Other inclusion/exclusion criteria may apply.

Where it is running

Rady Childrens Hospital San Diego - PIN — San Diego, California, United States
Childrens Center For Digestive Healthcare — Atlanta, Georgia, United States
Advocate Children's Hospital Park Ridge — Park Ridge, Illinois, United States
Boston Children's Hospital — Boston, Massachusetts, United States
MNGI Digestive Health PA-Plymouth — Minneapolis, Minnesota, United States
Mayo Clinic - PIN — Rochester, Minnesota, United States
Goryeb Children's Hospital — Morristown, New Jersey, United States
UPMC Children's Hospital of Pittsburgh-120 Lytton Ave — Pittsburgh, Pennsylvania, United States
Texas Childrens Hospital West Campus — Houston, Texas, United States
Carilion Children's Tanglewood Center — Roanoke, Virginia, United States
Children's Hospital at Westmead — Westmead, New South Wales, Australia
Queensland Childrens Hospital — South Brisbane, Queensland, Australia
Monash Health, Monash Medical Centre — Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PIN — Parkville, Victoria, Australia
UZ Antwerpen — Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Brussel - PIN — Jette, Brussels Capital, Belgium
Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg — Leuven, Vlaams Brabant, Belgium
University of Alberta Hospital — Edmonton, Alberta, Canada
British Columbia Children's Hospital — Vancouver, British Columbia, Canada
London Health Sciences Centre — London, Ontario, Canada
Beijing Children's Hospital, Capital Medical University - PIN — Beijing, Beijing Municipality, China
Henan Children's Hospital Zhengzhou Children's Hospital — Zhengzhou, Henan, China
Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China
The Children's Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Phoenix Childrens Hospital -1919 E Thompson Rd — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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