NCT04779320 is a Phase 3 clinical trial of Vedolizumab IV in Crohn's Disease (CD), sponsored by Takeda.

Who is sponsoring NCT04779320?

NCT04779320 is sponsored by Takeda.

What drugs are being tested in NCT04779320?

Interventions in NCT04779320: Vedolizumab IV.

What condition does NCT04779320 study?

NCT04779320 studies Crohn's Disease (CD).

Is NCT04779320 still recruiting?

NCT04779320 is currently recruiting now. Last updated 20 October 2025.

Last reviewed 2025-10-20 · How we verify

NCT04779320

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 20 October 2025

What this trial tests

Phase 3 trial testing Vedolizumab IV in Crohn's Disease (CD) in 120 participants. Currently enrolling.

Timeline

10 February 2022

Primary endpoint
22 May 2026

22 May 2026

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	10 February 2022
Primary completion	22 May 2026
Estimated completion	22 May 2026
Sites	96 locations across Italy, Japan, Slovakia, Greece, Belgium, United Kingdom, Israel, Hungary

Drugs / interventions tested

Vedolizumab IV — full drug profile →

Conditions studied

Crohn's Disease (CD) — all drugs for Crohn's Disease (CD) →

Sponsor

Takeda — full company profile →

Who can join

Adults 2 to 17, any sex, with Crohn's Disease (CD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

[Position paper of the Society for Paediatric Gastroenterology and Nutrition (GPGE) on the off-label use of biologics and signal inhibitors in children and adolescents with IBD that have already been approved for adults].
Däbritz J, Classen M, Krohn K, Krahl A, et al · · 2025 · PMID 39961333 · DOI 10.1055/a-2474-3104

Verify or expand the search:

Other trials of Vedolizumab IV

Trials testing the same drug.

NCT06581328 — A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting · Phase 4 · recruiting
NCT06100289 — A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease · Phase 3 · recruiting
NCT05837897 — A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease · Phase 3 · recruiting
NCT05442567 — A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) · Phase 3 · recruiting
NCT04804540 — A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease · Phase 4 · completed

Other recruiting trials for Crohn's Disease (CD)

Currently open trials in the same condition.

NCT07237516 — Zymfentra (Infliximab-dyyb) REal World Cohort STudy · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04779320 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 20 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04779320.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing