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NCT05281614 · ClinicalTrials.gov registry record · Early Phase 1
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
A Early Phase 1 study of Type 1 Diabetes, sponsored by Benaroya Research Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT05281614: Completed Early Phase 1 study of Type 1 Diabetes, sponsored by Benaroya Research Institute.
NCT05281614 is a Early Phase 1 study of Type 1 Diabetes that has completed, run by Benaroya Research Institute. The registered enrollment target is 20 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05281614, a Early Phase 1 study of Type 1 Diabetes, has completed, sponsored by Benaroya Research Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
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)
Primary Outcome
MMTT-Stimulated 2-Hour C-peptide AUC is the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.
Conditions Studied
Interventions
- DRUG Vedolizumab
- DRUG Etanercept
Study Locations (2)
California
- University of California San Diego - La Jolla
Washington
- Benaroya Research Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2024-01-10 |
| Phase | Early Phase 1 |
What the finished NCT05281614 record still lists
NCT05281614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Vedolizumab is the first listed.
NCT05281614 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT05281614 about?
NCT05281614 is a clinical study titled "Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D". 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 abo...
What is the current status of trial NCT05281614?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2022-09-21. Estimated completion is 2024-01-10.
What conditions does trial NCT05281614 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT05281614?
The interventions under investigation include: Vedolizumab (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT05281614?
This trial is sponsored by Benaroya Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05281614 being conducted?
This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05281614's enrollment target sits among peer trials
20 152nd of 198 higher than 41 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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