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A Phase 2b Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

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Updated on 19 February 2024

Summary

This extension study is intended to characterize the long-term safety profile of vedolizumab IV treatment in pediatric subjects with UC or CD who initiated treatment aged 2 to 17 years at the time of randomization in Study MLN0002-2003, and to describe the PK of a range of doses administered during the maintenance period (after clinical response to induction) and the correlation of the exposure to the drug with the clinical response.

Description

This extension study is intended to characterize the long-term safety profile of vedolizumab IV treatment in pediatric subjects with UC or CD who initiated treatment aged 2 to 17 years at the time of randomization in Study MLN0002-2003, and to describe the PK of a range of doses administered during the maintenance period (after clinical response to induction) and the correlation of the exposure to the drug with the clinical response.

Details
Condition ulcerative colitis,Crohn's disease
Age 100years or below
Clinical Study IdentifierTX9092
Last Modified on19 February 2024

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