Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
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.
Description
This protocol will enroll 66 participants within 100 days of T1D diagnosis who will be treated with either rezpegaldesleukin or placebo with subcutaneous injections over 26 weeks, administered once every 14 days. The rezpegaldesleukin/placebo treatment will be administered at the study site. Mixed meal tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months during the study. Once the 26-week treatment period has been completed, participants will continue follow-up visits until 12 months from the baseline visit.
Eligibility
- Age range
- 8–45 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Stimulated C-peptide of ≥ 0.2 pmol/mL measured during MMTT conducted at least 21 days from diagnosis of diabetes. * Participants ≥ 18 years old…
Interventions
- DrugRezpegaldesleukin
Rezpegaldesleukin 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.
- DrugPlacebo
Sterile saline for injection. Placebo will be administered in the same volume and as the active comparator to maintain treatment masking.
Locations (3)
- University of PittsburghPittsburgh, Pennsylvania
- Vanderbilt UniversityNashville, Tennessee
- University of British ColumbiaVancouver, British Columbia