The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
301
AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Clinical Response at week 6
Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
Time frame: Week 6
Clinical Response at week 52
Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
Time frame: Week 52
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Investigational Site 161704
Ciudad Autónoma de BuenosAires, Argentina
Investigational Site 161702
Córdoba, Argentina
Investigational Site 161701
Quilmes, Argentina
Investigational Site 161705
San Miguel de Tucumán, Argentina
Investigational Site 160111
Burgas, Bulgaria
Investigational Site 160102
Pleven, Bulgaria
Investigational Site 160109
Rousse, Bulgaria
Investigational Site 160101
Sliven, Bulgaria
Investigational Site 160103
Sofia, Bulgaria
Investigational Site 160105
Sofia, Bulgaria
...and 90 more locations