Parallel-Group Treatment, Double-Blind, 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects 18 to 80 Years Inclusive, Moderate to Severe Ulcerative Colitis
Overview
- Phase
- Phase 3
- Intervention
- AVT16
- Conditions
- Ulcerative Colitis
- Sponsor
- Alvotech Swiss AG
- Enrollment
- 301
- Locations
- 99
- Primary Endpoint
- Clinical Response at week 6
- Status
- Terminated
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Capable of giving signed informed consent
- •Male and female subjects from 18 to 80 years of age
- •Diagnosis of Ulcerative Colitis
Exclusion Criteria
- •Diagnosis of Crohn's colitis
- •Extensive colonic resection
- •Active or latent tuberculosis
Arms & Interventions
AVT16
Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
Intervention: AVT16
Entyvio
Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
Intervention: Vedolizumab
Outcomes
Primary Outcomes
Clinical Response at week 6
Time Frame: Week 6
Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
Secondary Outcomes
- Clinical Response at week 52(Week 52)