drugset / Trial / NCT07845955
JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a double-blind, randomized, placebo-parallel-controlled, multicenter study. The objective is to evaluate the efficacy and safety of Ivarmacitinib 8 mg administered for 52 weeks in preserving pancreatic β cell function in subjects with newly-onset type 1 diabetes mellitus. The study consists of a screening period (V1, up to 2 weeks), a 52-week double-blind treatment period (V2 to V14), and a 4-week safety follow-up period (V15).
Timeline
- Start
- 2026-09-30
- Primary completion
- 2029-08-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SHR0302 | Unknown | 8 mg | Oral |