JAK inhibitors versus calcineurin inhibitors as initial therapy for antisynthetase syndrome–associated ILD
Official title: A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
Run by China-Japan Friendship Hospital · NCT07406932 · Data updated 2026-11-12
This trial tests whether a JAK inhibitor or a calcineurin inhibitor, given with steroids, works better as the first treatment for antisynthetase syndrome–related interstitial lung disease in adults who haven’t been treated yet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Drugs / interventions | tofacitinib, baricitinib, upadacitinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07406932 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–75 with confirmed ASS‑ILD, active disease, and no prior glucocorticoids or immunosuppressants.
✕Probably not a fit
Patients with rapidly progressive ILD, uncontrolled infections, malignancy, pregnancy, or contraindications to the study drugs may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, open-label study comparing two initial treatment strategies for antisynthetase syndrome–associated interstitial lung disease. Participants will be adults with active, treatment‑naïve ILD meeting diagnostic criteria and randomized to receive either a JAK inhibitor or a calcineurin inhibitor alongside standard glucocorticoids. Primary outcome is 12‑month survival, with secondary outcomes including changes in lung function, HRCT scores, steroid-sparing effects, and proportion achieving low disease activity. Safety and laboratory parameters will be closely monitored during 12 months of treatment and follow-up, and analyses will explore potential predictors of response.
Why it matters
Potential benefit: If successful, the study could clarify which initial therapy provides better survival and lung function with acceptable safety for ASS‑ILD.
How similar studies have gone: Prior research in related ILD and autoimmune ILD approaches shows potential for targeted immunotherapy, but direct head‑to‑head data for JAK inhibitors versus calcineurin inhibitors in ASS‑ILD are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
-
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Qinghong Liu, MD
- Email: 166618530@qq.com
- Phone: +86 15774917676
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Chronic Respiratory Disease Participant Engagement
This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.
-
Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs
This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.
-
Finger vs. Earlobe Pulse Oximetry During a 6-Minute Walk Test in ILD
This study tests whether finger or earlobe pulse oximetry gives the same oxygen saturation readings during a 6-minute walk in people with interstitial lung disease.
-
Tele-Pulmonary Rehabilitation for Chronic Lung Diseases
This study tests whether a remote tele-rehabilitation program helps people with chronic lung diseases start and stick with pulmonary rehab better than usual center-based care.
-
Breathlessness in respiratory diseases: who feels it and why
This study tests how physiology, psychology, function, and breathing patterns relate to breathlessness in people with respiratory conditions compared with healthy controls.
-
Non-invasive tests to help ILD diagnosis and prognosis in pigeon fanciers and ILD patients
Aims to see if easy blood and breath tests can help diagnose and predict outcomes for interstitial lung disease, starting with pigeon fanciers at risk and then extending to ILD patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.