drugset / Trial / NCT03243058
Low-dose IL-2 in Established T1D - The "PROREG" Study
Phase 1/2
Withdrawn
Jay S. Skyler
Diabetes Research Institute Foundation · collabUniversity of California, San Francisco · collabUniversity of Florida · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.
Timeline
- Start
- 2023-06
- Primary completion
- 2026-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 500000 iu | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 1e+06 iu | Subcutaneous |