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NCT04779320 · ClinicalTrials.gov registry record · Phase 3

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

A Phase 3 study of Crohn's Disease (CD), sponsored by Takeda.

Recruiting
Registry status
Phase 3
Development phase
120
Enrollment target
20
Study locations

NCT04779320 is a Phase 3 study of Crohn's Disease (CD) that is actively recruiting participants, run by Takeda. The registered enrollment target is 120 participants, below the 178-participant average among 5 other Crohn's Disease (CD) trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04779320, a Phase 3 study of Crohn's Disease (CD), is actively recruiting participants, sponsored by Takeda.

RECRUITING
Registry status
Phase 3
Development phase
120 participants
Enrollment target
20
Study locations

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

Crohn's Disease (CD)

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

FieldValue
Enrollment Target 120 participants
Start Date 2022-02-10
Est. Completion 2026-05-22
Phase Phase 3

Sponsor

Takeda

408 total trials

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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, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 5 other Crohn's Disease (CD) trials with a reported enrollment target (33% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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.

NCT04779320 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Minnesota.

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).

What interventions are being tested in trial NCT04779320?

The interventions under investigation include: Vedolizumab IV (DRUG).

Who is sponsoring clinical trial NCT04779320?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.