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Clinical trial

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

NCT06100289 is registered in ClinicalTrials.gov with Takeda as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Takeda
Phase
Phase 3
Overall status
Recruiting
Start date
January 22, 2025
Completion date
May 16, 2028
Enrollment
70 (estimated)
Sites
54

Conditions

As the registry lists them; a condition with its own page is linked.

crohn's disease, ulcerative colitis