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 | Not Yet Recruiting DMC

• 1 other identifier: JAKCNIASSILD
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Antisynthetase Syndrome; Interstitial Lung Disease (ILD)

Outcome Measures

Primary Outcomes (1)

• 12-month survival rate

  Proportion of participants surviving at 12 months after randomization, with survival defined as the time from randomization to death from any cause.

  12 months

Secondary Outcomes (4)

• Annual decline rate of lung function (FVC% and DLCO%)

  Change from baseline to 12 months

• Change in HRCT score

  Change from baseline to 12 months

• Rate of glucocorticoid tapering

  Over 12 months

• Proportion of patients achieving low disease activity (LDA)

  At 6 months and 12 months

Study Arms (2)

JAK inhibitor group

EXPERIMENTAL

Participants in this arm will receive one of the JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) in combination with a standard glucocorticoid regimen (methylprednisolone 0.5g IV for 3 days, followed by oral prednisone 0.8-1.0 mg/kg/day tapered to 7.5 mg/day over 12 months). Treatment duration is 12 months.

Drug: JAK Inhibitor

Calcineurin inhibitor group

EXPERIMENTAL

Participants in this arm will receive either tacrolimus (0.075 mg/kg/day in two divided doses) or cyclosporine (2-5 mg/kg/day in two divided doses) in combination with the same standard glucocorticoid regimen as the experimental group. Treatment duration is 12 months.

Drug: Calcineurin Inhibitors (CNI)

Interventions

JAK Inhibitor DRUG

Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid therapy for 12 months.

JAK inhibitor group

Calcineurin Inhibitors (CNI) DRUG

Oral calcineurin inhibitors (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses) administered in combination with standard glucocorticoid therapy for 12 months.

Calcineurin inhibitor group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Antisynthetase syndrome; Lung Diseases, Interstitial

Interventions

Janus Kinase Inhibitors; Calcineurin Inhibitors

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Qinghong Liu, MD

CONTACT

+86 15774917676; 166618530@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02