Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

NCT06100289 · View on ClinicalTrials.gov ↗

Study Summary

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.

Interventions

  • DRUG Vedolizumab IV
  • DRUG Vedolizumab SC

Study Locations (20)

Other

  • Cliniques Universitaires Saint-Luc — Brussels
  • Centre Hospitalier Chretien MontLegia — Liège
  • University Hospital "Saint George" — Plovdiv
  • Specialized Hospital for Active Treatment of Children Diseases "Prof. Dr. Ivan Mitev" EAD — Sofia
  • H.C Andersens Hospital — Odense
  • Childrens Health Ireland — Dublin
  • Azienda Ospedaliera Universitaria Gaetano Martino Messina — Messina
  • V. Buzzi Hospital — Milan

California

  • VVCRD Clinical Research — Garden Grove
  • Loma Linda University School of Medicine — Loma Linda
  • Children's Hospital Of Orange County — Orange
  • Stanford Children's Health — Palo Alto

Illinois

  • Advocate Children's Hospital — Park Ridge

Michigan

  • Children's Hospital of Michigan — Detroit

New Jersey

  • Atlantic Health System — Morristown

New York

  • New York Presbyterian Hospital, Weill Cornell Medical College — New York

Ohio

  • Cleveland Clinic Foundation — Cleveland

Oklahoma

  • The University of Oklahoma Health Sciences Center — Oklahoma City

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2025-01-22
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06100289

The ClinicalTrials.gov registry entry for NCT06100289 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 70 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 Vedolizumab IV 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: NCT06100289 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Illinois. 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 NCT06100289 about?

NCT06100289 is a clinical study titled "A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease". The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for...

What is the current status of trial NCT06100289?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2025-01-22. Estimated completion is 2027-06-30.

What conditions does trial NCT06100289 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 NCT06100289?

The interventions under investigation include: Vedolizumab IV (DRUG), Vedolizumab SC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06100289?

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 NCT06100289 being conducted?

This trial has 20 study locations across California, Illinois, Michigan, New Jersey, New York. 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