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Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D

NCT05281614 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-24

No results posted yet for this study

Summary

The underlying hypothesis is that vedolizumab will modify immune cell trafficking in type 1 diabetes, and that this will be enhanced by pre-treatment with etanercept. This study will determine whether there is mechanistic evidence in support of this hypothesis and provide preliminary information about safety, efficacy, and tolerability of vedolizumab with and without pretreatment with etanercept in adults with type 1 diabetes (T1D)

Conditions

Interventions

DRUG

Etanercept

Etanercept is a fully humanized monoclonal antibody that targets TNFα.

DRUG

Vedolizumab

Vedolizumab is a humanized monoclonal antibody that targets α4ß7 integrin.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-01-10
Completion
2024-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281614 on ClinicalTrials.gov