An Open-label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Who Achieved Clinical Response Following Open–label Vedolizumab Intravenous Therapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503188-40-00

Acronym

VedolizumabSC-3003

Enrollment

Registered

2024-11-11

Start date

2025-01-06

Completion date

Unknown

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Ulcerative Colitis or Crohn’s Disease

Brief summary

01. Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34 [Time Frame: Predose at Week 34], 02. Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34 [Time Frame: Multiple time points prior to Week 34; pre-dose at Week 34]

Detailed description

01. Percentage of Participants with Positive Antivedolizumab Antibody (AVA) [Baseline up to 18 weeks after last dose of study drug (up to Week 50)], 02. Percentage of Participants with Positive Neutralizing AVA [Baseline up to 18 weeks after last dose of study drug (up to Week 50)]

Interventions

DRUGEntyvio 300 mg powder for concentrate for solution for infusion

DRUGEntyvio 108 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
01. Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34 [Time Frame: Predose at Week 34], 02. Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34 [Time Frame: Multiple time points prior to Week 34; pre-dose at Week 34]	—

Secondary

Measure	Time frame
01. Percentage of Participants with Positive Antivedolizumab Antibody (AVA) [Baseline up to 18 weeks after last dose of study drug (up to Week 50)], 02. Percentage of Participants with Positive Neutralizing AVA [Baseline up to 18 weeks after last dose of study drug (up to Week 50)]	—

Countries

Belgium, Bulgaria, Denmark, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026