Ground Truth
Inclusion Criteria:Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association.Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.Has a positive result on testing for T1D-related autoantibodies.Exclusion Criteria:Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.Has an active infection and/or fever.Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Prediction
**Modified Eligibility Criteria (version 33)**
**Inclusion Criteria:**
- Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
- Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
- Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
- Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
- Has a positive result on testing for T1D-related autoantibodies.
- Has received non-infectious vaccines within 2 weeks before through 6 weeks after each dosing course.
**Exclusion Criteria:**
- Has any autoimmune disease other than T1D, with the exception of stable thyroid or celiac disease.
- Has an active infection and/or fever.
- Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- An individual who has a medical, psychological, or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
- Has a clinically active infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) or a viral load of ≥10,000 copies per mL or per 106 lymphocytes at screening.
- Has a diagnosis of significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2X upper limit of normal (ULN) or total bilirubin (TBili) >1.5X ULN, except for subjects with Gilbert’s syndrome with normal ALT and AST with approval of the Medical Monitor.