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VARSITY: Vedolizumab vs Adalimumab in Ulcerative Colitis
NCT02497469Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2015
- Primary completion
- Sep 2018
- Countries
- 34
- Sponsor
- Takeda
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- vedolizumab
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 3, randomised, double-blind trial of vedolizumab in ulcerative colitis (UC) (2 arms), sponsored by Takeda. Primary endpoint: Percentage of Participants Who Achieved Clinical Remission at 52 weeks. Started Jun 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Vedolizumab IV
Vedolizumab 300 mg IV at Weeks 0, 2, 6, 14, 22, 30, 38, 46 + Adalimumab placebo
Adalimumab SC
Adalimumab 160 mg SC Week 0, 80 mg Week 2, then 40 mg every 2 weeks + Vedolizumab placebo
03
Who it enrols
Adults with moderately to severely active ulcerative colitis (Mayo score 6-12) who have failed or are intolerant to conventional therapy or TNF antagonists (excluding adalimumab failure).
04
Endpoints
Primary
Percentage of Participants Who Achieved Clinical Remission
Secondary
Percentage of Participants Who Achieved Mucosal Healing
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
05
Results
Primary endpoints met
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