drugset / Trial / NCT07406932

A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome

NCT07406932

Recruiting 80 enrolled China-Japan Friendship Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective investigation comparing the efficacy and safety of Janus kinase inhibitors versus calcineurin inhibitors as initial therapy for interstitial lung disease associated with antisynthetase syndrome. The goal is to determine which treatment is more effective at improving lung function and preventing disease progression, while comparing their safety profiles. The findings will help provide clearer treatment guidance for doctors and patients.

Timeline

Start
2026-05-18
Primary completion
2027-07-01
Completion
2027-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Baricitinib Small molecule 4 mg Oral
Subject Cyclosporine Peptide 2 mg/kg Oral
Subject Cyclosporine Peptide 5 mg/kg Oral
Subject Tacrolimus Small molecule 0.075 mg/kg Oral
Subject Tofacitinib Small molecule 5 mg Oral
Subject Upadacitinib Small molecule 15 mg Oral