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A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
NCT04779320 · View on ClinicalTrials.gov ↗
Study Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
Conditions Studied
Interventions
- DRUG Vedolizumab IV
Study Locations (20)
New York
- The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS — New Hyde Park
- University of Rochester Medical Center PPDS — Rochester
- Stony Brook University Medical Center — Stony Brook
- SUNY Upstate Medical Center — Syracuse
California
- Cedars Sinai Medical Center — Los Angeles
- Rady Childrens Hospital San Diego - PIN — San Diego
- University of California San Francisco — San Francisco
Minnesota
- MNGI Digestive Health, PA — Minneapolis
- Mayo Clinic - PIN — Rochester
Arizona
- Phoenix Childrens Hospital — Phoenix
Florida
- I.H.S Health LLC — Kissimmee
Georgia
- Childrens Center For Digestive Healthcare — Atlanta
Illinois
- Advocate Children's Hospital Park Ridge — Park Ridge
Indiana
- Riley Hospital For Children — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-02-10 |
| Est. Completion | 2026-05-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04779320
The ClinicalTrials.gov registry entry for NCT04779320 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 120 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 1 condition, with Crohn's Disease (CD) appearing as the primary indexed condition, and to 1 intervention — 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: NCT04779320 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Minnesota. 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 NCT04779320 about?
NCT04779320 is a clinical study titled "A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)". Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with ...
What is the current status of trial NCT04779320?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2022-02-10. Estimated completion is 2026-05-22.
What conditions does trial NCT04779320 study?
This clinical trial studies the following conditions: Crohn's Disease (CD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04779320?
The interventions under investigation include: Vedolizumab IV (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04779320?
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 NCT04779320 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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