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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06570772

Enrollment

301

Registered

2024-08-26

Start date

2024-09-23

Completion date

2025-11-25

Last updated

2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

BIOLOGICALAVT16

AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46

BIOLOGICALVedolizumab

Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response at week 6	Week 6	Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome

Secondary

Measure	Time frame	Description
Clinical Response at week 52	Week 52	Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome

Countries

Argentina, Bulgaria, Croatia, Georgia, Latvia, Poland, Romania, Serbia, Slovakia, Sri Lanka, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026