NCT05743244

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Detailed description

This study has a total sample size of 78 participants. Of that 78, 52 participants will receive active treatment, and a total of 26 participants will receive placebo. Participants will receive 12 months of active treatment with abrocitinib, ritlecitinib, or placebo with up to 12 months of additional follow-up. During the study, participants will undergo frequent assessments of their insulin production, immunologic status, overall health and well-being and diabetes care.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Abrocitinib 200 MG Oral Tablet	Abrocitinib
DRUG	Ritlecitinib	Ritlecitinib
DRUG	Placebo	Placebo for Abrocitinib or Ritlecitinib

Timeline

• Start date: 2023-10-19
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2023-02-24
• Last updated: 2025-10-01

Locations

30 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study