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Monoclonal Antibodies
Vedolizumab +/− Etanercept for Type 1 Diabetes (COBRA Trial)
Phase < 1
Recruiting
Research Sponsored by Benaroya Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females 18-45 years of age, inclusive
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), Random (non-fasting) C-peptide or peak MMTT stimulated C-peptide ≥ 0.2 pmol/mL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline dose to 10 weeks and baseline dose to 52 weeks
Awards & highlights
COBRA Trial Summary
This trial will test whether a drug called vedolizumab, used to treat Crohn's disease and ulcerative colitis, can also be used to treat type 1 diabetes. The trial will also test whether pretreating with another drug, etanercept, can enhance vedolizumab's effectiveness.
Who is the study for?
Adults aged 18-45 with Type 1 Diabetes, diagnosed between 21 days and 3 years ago, who have certain diabetes-related autoantibodies. Participants must be up to date on immunizations, not pregnant or breastfeeding, willing to use birth control, and without serious health conditions that could affect trial safety.Check my eligibility
What is being tested?
The trial is testing whether Vedolizumab can change immune cell behavior in Type 1 Diabetes patients and if this effect is improved by first taking Etanercept. It aims to provide initial data on the combination's safety, effectiveness, and how well patients tolerate it.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as infections due to lowered immunity. There might also be injection site reactions or allergic responses given these are monoclonal antibody treatments.
COBRA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Select...
I have diabetes-related antibodies or my C-peptide levels are adequate.
COBRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline dose to 10 weeks and baseline dose to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline dose to 10 weeks and baseline dose to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events of etanercept treatment as a measure of safety and tolerability
Adverse events of vedolizumab treatment as a measure of safety and tolerability
Impact on insulin secretion determined by 2-hour MMTT stimulated AUC C-peptide 10 weeks after first vedolizumab dose and 52 weeks after randomization.
Secondary outcome measures
Change in T1D antibody titers
Frequency and surface marker phenotype of other immune cells such as antigen specific CD4 and CD8 cells, memory and naive T and B cells
Frequency of myeloid DC1 cells
+1 moreSide effects data
From 2019 Phase 4 trial • 11 Patients • NCT025597139%
Crohn's disease
9%
Gastrointestinal motility disorder
9%
Paronychia
9%
Viral infection
9%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vedolizumab 300 mg
COBRA Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Arm B will receive 6 weeks of vedolizumab only. Final study visit at 52 weeks.
Group II: Arm AExperimental Treatment2 Interventions
Arm A will receive 6 weeks of vedolizumab after 8 weeks of etanercept. Final study visit at 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
FDA approved
Vedolizumab
FDA approved
Find a Location
Who is running the clinical trial?
University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,387 Total Patients Enrolled
Benaroya Research InstituteLead Sponsor
45 Previous Clinical Trials
11,297 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You recently started taking insulin.Criterion: The presence of glutamate decarboxylase (GAD-65) in the body.Your HbA1c level is less than or equal to 8.5% at the initial screening.I was diagnosed with Type 1 Diabetes between 3 weeks and 3 years ago.I do not have a serious uncontrolled illness or a history of cancer.I have an active Epstein-Barr virus infection confirmed by a PCR test.You have a low white blood cell count, low lymphocyte count, low platelet count, low hemoglobin, or low neutrophil count.I am up to date with all my vaccines, including COVID-19 and flu shots.I am between 18 and 45 years old.I'm sorry, but "IA-2" is not sufficient information for me to provide a simplified summary. If you could provide more context or details, I'd be happy to assist further.My liver tests are higher than normal.I am not on any medication that affects blood sugar, except for possibly some topical or inhaled steroids.My condition involves ZnT8.I have tested positive for TB or have a history of TB.You have a current infection with CMV, as confirmed by a specific type of test called real-time PCR.I have used non-insulin treatments for high blood sugar in the last 30 days.I have diabetes-related antibodies or my C-peptide levels are adequate.I am waiting for or have a positive COVID-19 test result.You have evidence of current or past HIV, Hepatitis B, or Hepatitis C in your blood.You have a history of a weakened immune system.I have not had a serious infection in the last 3 months.I am not pregnant or breastfeeding.I have not received a live vaccine in the last 6 weeks.I agree not to get any live vaccines from 6 weeks before until 6 weeks after my treatment.You have had a serious allergic reaction to certain types of antibodies in the past.I am willing to use effective birth control during and for 12 weeks after the study.I haven't taken any immune-modifying drugs in the last 3 months.I have an autoimmune disease but it's not celiac or stable thyroid disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prerequisites must be met to join this research program?
"To be eligible for this clinical trial, individuals should have diabetes, suffer from an autoimmune disorder and fall within the age range of 18-45 years old. 20 participants will eventually take part in the research."
Answered by AI
How many participants can the trial accommodate in total?
"Affirmative. Information published on clinicaltrials.gov attests to the fact that this medical study is currently recruiting participants, having been posted on August 1st 2022 and recently modified on July 21st 2022. The trial seeks 20 individuals from 2 separate sites for participation."
Answered by AI
Does this experiment seek additional participants at present?
"Right. Data hosted on clinicaltrials.gov attests to the fact that this medical trial is actively recruiting patients, as it was first posted on August 1st 2022 and recently updated on July 21st of the same year. The research requires 20 participants from 2 different health institutions."
Answered by AI
Is the age requirement for this medical experiment limited to adults over 40?
"This trial is only available to those aged 18-45. By contrast, there are 155 trials geared towards minors and 178 specifically for seniors."
Answered by AI
What aims is this research endeavor attempting to attain?
"This clinical trial seeks to measure the impact of vedolizumab on insulin secretion using a 2-hour MMTT stimulated AUC C-peptide over baseline and 52 weeks. Secondary objectives are to evaluate changes in T1D antibody titers, frequency of myeloid DC1 cells, as well as antigen specific CD4 and CD8 cell phenotype data collected through flow cytometry or CyTOF with the AIM assay."
Answered by AI
Who else is applying?
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
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