Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

Alvotech

Status and phase: Enrolling; Phase 3

Conditions: Ulcerative Colitis

Treatments: Biological: Vedolizumab; Biological: AVT16

Study type: Interventional

Funder types: Industry

Identifiers

NCT06570772

AVT16-GL-C01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 748 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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748 participants in 2 patient groups

AVT16

Experimental group

Description:

Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)

Treatment:

Biological: AVT16

Entyvio

Active Comparator group

Description:

Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16

Treatment:

Biological: Vedolizumab