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
Parallel
Rezpegaldesleukin
DrugRezpegaldesleukin will be dosed at 12 μg/kg for subcutaneous injection. Rezpegaldesleukin will be provided as a 1.5 mg/mL sterile solution in a vial for injection preparation. Study agent injections will be administered in the abdomen, back of the upper arm or the upper thigh of the participant.
Placebo
DrugSterile saline for injection. Placebo will be administered in the same volume and as the active comparator to maintain treatment masking.
The area under the stimulated C-peptide curve (AUC) Y_MAUC.
The primary outcome of each participant is the mean area under the stimulated C-peptide curve (AUC) over the 2-hour mixed meal glucose tolerance test conducted at the 12-month visit in nmol/L, denoted as Y\_MAUC.
Change of MMTT C-peptide mean AUC
This measure will investigate the change of MMTT C-peptide mean AUC between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.
Adverse Events
Number of adverse events and severity reported over the course of the study
Total Daily Insulin Dose per kilogram
Total Daily insulin Dose per kilogram as collected every 3 months once enrolled in the study to 1 year post enrollment.
Change in Quantitative Response (QR) in placebo and treatment groups over time
Investigate the effect on beta cell function at 6 and 12 months in comparison to both contemporaneous placebo-treated participants and historical model-adjusted placebo controls as defined by the Quantitative Response (QR).
Hypersensitivity Events and Urticaria
Participants who experience hypersensitivity or urticaria within 48 hours of the first dose will undergo the laboratory assessments described in the protocol, if it is possible and feasible for the participant and the site.
Injection Site Reactions
Any Injection Site Reaction (ISR) that is assessed and reported as an adverse event at grade 1 or greater level will be reported.
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