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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTakeda

About this trial

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.

Eligibility criteria

Qualifiers

In the investigator's opinion, the participant can understand and comply with protocol requirements.

The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.

The participant is 18 to 80 years of age at the time of signing the ICF.

The participant's immunization is up to date per vedolizumab US prescribing information (USPI).

Disqualifiers

Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening.

Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.

Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).

In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration [FDA] 2024).

Trial design

Treatments tested in this trial

  • Vedolizumab IV
  • Vedolizumab SC

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators