Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Vedolizumab IV for Ulcerative Colitis

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).

Official registry: https://clinicaltrials.gov/study/NCT06581328 · Takeda · enrollment listed as 200

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vedolizumab IV, or Vedolizumab SC. The registry lists allocation as randomized. 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.

They plan to enroll about 200 people at 101 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

Interventions: Vedolizumab IV, Vedolizumab SC

Primary outcome (registry wording): Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • To be eligible to participate in this study, participants must meet all the following criteria:
  • In the investigator's opinion, the participant can understand and comply with protocol requirements
  • 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)
  • Participants must meet the contraception recommendations
  • The participant has a diagnosis of moderate to severely active UC or CD defined by the following:
  • CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR

Public study contact (from the registry)

Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

101 listed

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FAQ about this NCT record

Is NCT06581328 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06581328?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06581328?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary