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A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

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Trial Profile

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2026

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms KEPLER
  • Sponsors Takeda; Takeda Development Center Americas

Most Recent Events

  • 09 Jun 2026 According to Takeda media release, the company has submitted a marketing authorization application (MAA) to the European Medicines Agency for ENTYVIO IV for the treatment of moderately to severely active UC and Crohns disease in pediatric patients ages 2 years and older, and plans to submit applications in additional markets later this year.
  • 09 Jun 2026 According to Takeda media release, company announced the USFDA has accepted for review its supplemental Biologics License Application (sBLA) for intravenous (IV) ENTYVIO (vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohns disease in pediatric patients ages 2 years and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of calendar year 2027.
  • 19 Feb 2026 According to Takeda Media release,Nearly half (47.3%) of participants achieved the primary endpoint of clinical remission at Week 54.

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