Status:
COMPLETED
Early Markers of Disease and Response to Therapy
Lead Sponsor:
Sandra Lord, MD
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Medical College of Wisconsin
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-55 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, part...
Eligibility Criteria
Inclusion
- ≤ 7 months from type 1 diabetes diagnosis based on ADA criteria
- \> 21 days from type 1 diabetes diagnosis or metabolically stable per study physician assessment
- Males and females 6-55 years of age, inclusive, at time of screening visit
- Peak MMTT stimulated C-peptide ≥ 0.2 pmol/ml
- Females of child-bearing age must be willing to use effective birth control for 1 year (which may include abstinence) from screening visit and undergo regular pregnancy testing
- Up to date for clinically recommended immunizations prior to screening
- Willing to forgo live vaccines 3 months prior to the screening visit until three months following last study drug administration
- Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age
- Weight ≥ 20 kg at baseline visit
- HbA1c ≤ 8.5% at baseline visit
- Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy)
Exclusion
- Concurrent or recent (within the past 30 days of screening MMTT (visit -1)) use of non-insulin therapies aimed to control hyperglycemia
- Females who are pregnant or lactating
- Immunodeficiency or clinically significant chronic lymphopenia
- Have an active infection at time of screening or baseline visit
- Recent exposure, or possible or known active SARS-CoV-2 infection as defined by public health guidelines
- Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection
- Active infection with EBV or CMV, defined by real-time PCR
- History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac disease and stable thyroid disease
- Require use of other immunosuppressive agents for any other condition
- Use of medications known to influence glucose tolerance
- Have any complicating medical or psychological issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. These include pre-existing cardiac disease, COPD, neurological, or clinically significant blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia).
- Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.
- Have a history of malignancies
- Receipt of live vaccine (MMR, intranasal influenza, varicella, rotatvirus) in 3 months before treatment
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04118153
Start Date
March 5 2021
End Date
May 24 2024
Last Update
June 4 2024
Active Locations (2)
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1
Benaroya Research Institute
Seattle, Washington, United States, 98101
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226