JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D:A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus Protocol TN 31
Study ID: STU-2023-1068
Summary
This phase 2 trial is a double-blind, randomized, placebo-controlled clinical trial in male and female adolescent and adult participants (ages 12-35 years) with newly diagnosed Stage 3 T1D (within 100 days of diagnosis). Enrollment into abrocitinib and ritlecitinib arms and the shared placebo arm will occur in a 1:1:1 allocation with a planned enrollment of 26 participants in each arm. Participants will receive 12 months of active treatment with abrocitinib, ritlecitinib, or placebo with up to 12 months of additional follow-up. A total sample size of 52 participants will receive active treatment, and a total of 26 participants will receive placebo.
The primary objective of this study is to evaluate the efficacy of subtype selective Janus kinase (JAK) inhibitors in the preservation of ß cell function in participants with recent onset Stage 3 T1D (diagnosed within 100 days).
