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.
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
Ciudad Autónoma de BuenosAires, Argentina
Córdoba, Argentina
Quilmes, Argentina
San Miguel de Tucumán, Argentina