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Study identifier: NCT06581328 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Condition: Ulcerative Colitis · Crohn's Disease  ·  Sponsor: Takeda

PhasePhase 4
Planned participants400
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.

This description comes directly from the study's public registry record.

Talk to the study team

Takeda Contact  ·  +1-877-825-3327  ·  medinfoUS@takeda.com

Always discuss trial participation with your own doctor first.

Locations (101)

Gastro HealthBirmingham, Alabama, United StatesRecruiting
East View Medical ResearchMobile, Alabama, United StatesRecruiting
AZ Gastro CareChandler, Arizona, United StatesRecruiting
Spectrum Research Institute LLCGilbert, Arizona, United StatesRecruiting
GI Alliance- Sun CitySun City, Arizona, United StatesRecruiting
UAMS Health Gastroenterology ClinicLittle Rock, Arkansas, United StatesWithdrawn
Gastroenterology and Liver InstituteEscondido, California, United StatesRecruiting
Inland Empire GastroenterologyMurrieta, California, United StatesWithdrawn
United Clinical Research InstituteMurrieta, California, United StatesRecruiting
Digestive Health InstituteNewport Beach, California, United StatesWithdrawn
Knowledge Research CenterOrange, California, United StatesWithdrawn
Medical Associates Research Group, Inc.San Diego, California, United StatesWithdrawn

+ 89 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06581328