A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
Recruiting now · Not applicable
Conditions studied: Antisynthetase Syndrome, Interstitial Lung Disease (ILD)
In brief
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.
Key facts
- Study ID
- NCT07406932
- Run by
- China-Japan Friendship Hospital
- People needed
- 80
- Starts
- 2026-05-18
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 75 years.
- Meet the 2017 EULAR/ACR diagnostic criteria for Anti-synthetase Syndrome (ASS).
- Presence of Interstitial Lung Disease (ILD) confirmed by High-Resolution Computed Tomography (HRCT).
- Active disease requiring initiation or intensification of immunosuppressive therapy, with no prior use of glucocorticoids, immunosuppressants, or biologics.
- Signed informed consent form.
You may not qualify if…
- Diagnosis of Rapidly Progressive ILD (RP-ILD), defined as worsening dyspnea within 1 month and PaO2/FiO2 ratio < 250 mmHg.
- Active uncontrolled severe infection, malignancy, or major organ failure.
- Pregnancy or lactation.
- Contraindications to the study drugs.
- Concurrent use of other immunosuppressants or biologics.
Where it is running
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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