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COMPLETEDEARLY_PHASE1

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

NCT05281614•Benaroya Research Institute

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)

Detailed Description

Vedolizumab directly blocks integrin α4ß7 on circulating immune cells preventing their egress from the blood, while etanercept blocks the TNFα signaling necessary for the α4ß7 cognate addressin MAdCAM-1 to be expressed in pancreatic endothelial cells. For these reasons, the investigators hypothesize that the two agents may synergistically prevent diabetogenic immune cells from trafficking from the periphery to their target tissue to cause islet cell destruction. Cells from both the myeloid (e.g., myeloid DC1 cells and non-classical monocytes) and lymphoid compartments (e.g., diabetes antigen-specific T cells) would be impacted by this therapeutic combination.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females 18-45 years of age, inclusive
•2. Diagnosis of T1D between 21 days and 3 years from screening
•3. Positive for at least one diabetes-related autoantibody any time since diagnosis, including but not limited to:
•* Glutamate decarboxylase (GAD-65)
•* mIAA, if obtained within 10 days of the onset of exogenous insulin therapy
•* IA-2
•* ZnT8 (Zinc transporter 8)
•4. Random (non-fasting) C-peptide or peak MMTT stimulated C-peptide ≥ 0.2 pmol/mL.
•5. Females of child-bearing potential must be willing to use effective birth control from the screening visit through 12 weeks post last dose of study medication.
•6. Up to date for clinically recommended immunizations including COVID-19 and seasonal influenza vaccine at least 3 weeks prior to baseline treatment.
+3 more criteria

Exclusion Criteria

•1. History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
•2. History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease
•3. History of immunodeficiency
•4. Recent (within 3 months) serious bacterial, viral, fungal, or other infections
•5. Pending or positive SARS-CoV-2 test or symptoms of possible COVID-19 illness at baseline treatment visit.
•6. Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.
•7. Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.
•8. Active infection with EBV as defined by real-time polymerase chain reaction (PCR).
•9. Active infection with CMV as defined by real-time PCR.
•10. Clinically significant liver function abnormalities as defined by ALT or AST\> 1.5 x the upper limit of age-determined normal (ULN).
+14 more criteria

Locations (2)

University of California San Diego

La Jolla, California, United States

Benaroya Research Institute

Seattle, Washington, United States

Key Dates

Start Date

September 21, 2022

Primary Completion Date

January 10, 2024

Completion Date

January 10, 2024

Last Updated

May 24, 2024

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Etanercept

DRUG

Vedolizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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