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Clinical trial

An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)

NCT04738942 is registered in ClinicalTrials.gov with Takeda as lead sponsor.

NCT NCT04738942
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)
Lead sponsor
Takeda
Phase
Phase 3
Overall status
Active, not recruiting
Start date
June 4, 2021
Completion date
November 30, 2027
Enrollment
56 (actual)
Sites
20

Conditions

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

crohn's disease, ulcerative colitis