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 3interventionalRules rewrite

Phase 3: testing Vedolizumab IV for Crohn's Disease

This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks.

Official registry: https://clinicaltrials.gov/study/NCT05837897 · Takeda · enrollment listed as 408

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

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 Placebo. The registry lists allocation as randomized. This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China.

They plan to enroll about 408 people at 43 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-Controlled Induction Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Subjects in China With Moderately to Severely Active Crohn's Disease

Interventions: Vedolizumab IV, Placebo

Primary outcome (registry wording): Percentage of Participants Achieving Clinical Response at Week 14

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy
  • The participant has CD involvement of the ileum and/or colon, at a minimum
  • A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening)
  • The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:

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

43 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT05837897 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 NCT05837897?

Phase 3. 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 NCT05837897?

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

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