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RECRUITING Phase 3

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT05442567 · View on ClinicalTrials.gov ↗

Study Summary

The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

Interventions

  • OTHER No Intervention
  • DRUG Vedolizumab IV

Study Locations (20)

Minnesota

  • MNGI Digestive Health PA-Plymouth — Minneapolis
  • Mayo Clinic - PIN — Rochester

Victoria

  • Monash Health, Monash Medical Centre — Clayton
  • Royal Children's Hospital Melbourne - PIN — Parkville

Arizona

  • Phoenix Childrens Hospital -1919 E Thompson Rd — Phoenix

California

  • Rady Childrens Hospital San Diego - PIN — San Diego

Georgia

  • Childrens Center For Digestive Healthcare — Atlanta

Illinois

  • Advocate Children's Hospital Park Ridge — Park Ridge

Maryland

  • Johns Hopkins University — Baltimore

Massachusetts

  • Boston Children's Hospital — Boston

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2023-05-16
Est. Completion 2031-08-15
Phase Phase 3

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05442567

The ClinicalTrials.gov registry entry for NCT05442567 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which No Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05442567 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Minnesota, Victoria, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05442567 about?

NCT05442567 is a clinical study titled "A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)". The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

What is the current status of trial NCT05442567?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2023-05-16. Estimated completion is 2031-08-15.

What conditions does trial NCT05442567 study?

This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05442567?

The interventions under investigation include: No Intervention (OTHER), Vedolizumab IV (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05442567?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05442567 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial