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Immunological Profiles and Recapture of Clinical Response with Vedolizumab in Ulcerative Colitis
KCT0011841Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2026
- Countries
- 1
- Sponsor
- Takeda
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- vedolizumab
- Conditions
- autoimmune colitis
01
Overview
Phase 4, randomised, open-label trial of vedolizumab in autoimmune colitis, sponsored by Takeda. Primary endpoint: Week 24 recapture of clinical response. Planned start Jun 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- RandomizedOpen-label
Vedolizumab treatment arm
Patients with ulcerative colitis and secondary loss of response receiving vedolizumab in an open-label, randomized treatment strategy.
03
Who it enrols
Adult Korean patients with moderate to severe ulcerative colitis and secondary loss of response to vedolizumab (Entyvio) are eligible; healthy volunteers are not included.
04
Endpoints
Primary
Week 24 recapture of clinical response
Secondary
Week 12 immunological profiles
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