This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.
Provide informed consent or assent as appropriate and if < 18 years of age have a parent or legal guardian provide informed consent.
Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A.
Diagnosis of T1D within 100 days of randomization.
Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A.
One or more screening laboratory values as stated
Neutrophils < 1,500 /μL
Lymphocytes < 800 /μL
Platelets < 100,000 /μL
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead sponsor