ClinicalTrials.gov record 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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old to 75 years old

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, open-label study compares JAK inhibitors versus calcineurin inhibitors as first drug therapy for interstitial lung disease (ILD) linked to antisynthetase syndrome. Eligible adults who are treatment‑naïve to glucocorticoids, immunosuppressants, and biologics receive one of the two drug regimens plus a standard glucocorticoid plan for 12 months. The main outcome is survival at 12 months; lung function, CT scores, steroid reduction, disease activity, and safety are also measured.

What it is studying. The study tests differences between starting JAK inhibitors versus calcineurin inhibitors, each given with standard glucocorticoids, on 12-month survival and on lung-related outcomes (lung function, CT findings), steroid tapering, and safety in people with ASS‑ILD.

What the researchers hope to learn. To compare the efficacy and safety of JAK inhibitors versus calcineurin inhibitors as initial therapy for antisynthetase syndrome–associated ILD. Primary scientific goal: measure 12-month survival. Secondary goals: compare rates of lung function decline (FVC% and DLCO%), changes on high-resolution CT, glucocorticoid tapering, and proportion achieving low disease activity.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: JAK Inhibitor
Calcineurin Inhibitors (CNI)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a single-center, randomized, open-label, prospective study. Eligible adults with interstitial lung disease associated with antisynthetase syndrome (ASS-ILD) who are treatment-naïve will be randomly assigned to receive either a JAK inhibitor (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) or a calcineurin inhibitor (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses), both in combination with a standard glucocorticoid regimen. The primary endpoint is the 12-month survival rate. Secondary endpoints include changes in lung function, high-resolution CT (HRCT) scores, glucocorticoid dosage reduction, and the proportion of patients achieving low disease activity. Safety and laboratory parameters will be closely monitored throughout the 12-month treatment and follow-up period. Statistical analyses will compare the efficacy and safety profiles between the two treatment arms, and subgroup analyses will be performed to explore potential predictors of treatment response.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If enrolled, people are randomly assigned (open-label) to one of two oral drug regimens for 12 months: a JAK inhibitor (tofacitinib, baricitinib, or upadacitinib) or a calcineurin inhibitor (tacrolimus or cyclosporine), each given together with a standard glucocorticoid plan (methylprednisolone IV for 3 days, then prednisone tapered to 7.5 mg/day over 12 months). Participants will have regular clinic visits with lung function tests, HRCT imaging, and safety/laboratory monitoring throughout treatment and follow-up. The study team will track steroid dose changes and measures of disease activity during the 12-month period.

How the study is structured. A single-center, randomized, open-label trial with two parallel treatment arms. Participants are assigned to a JAK inhibitor (tofacitinib, baricitinib, or upadacitinib) or a calcineurin inhibitor (tacrolimus or cyclosporine), each combined with a standard glucocorticoid regimen. Treatment and follow-up last 12 months; outcomes and safety are monitored throughout.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on anti-synthetase syndrome

Clinical trials11 trials listed for anti-synthetase syndromeEvery trial the registry lists for anti-synthetase syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in anti-synthetase syndrome researchLatest monthly update: September 2026. Includes: Lung medicine pattern. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 18, 2026 (estimated)
Primary completion: Jul 1, 2027 (estimated)
Study completion: Jul 1, 2027 (estimated)
Target enrollment: 80 participants (estimated)
Last updated on registry: Jun 3, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: China-Japan Friendship Hospital
Principal investigator: Qinghong Liu, Physician
China-Japan Friendship Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Qinghong Liu, MD 📞 +86 15774917676 ✉ 166618530@qq.com

Participating sites (1)

China-Japan Friendship HospitalRecruiting
Beijing, Beijing Municipality, 100029 · China
- Qinghong Liu · 15774917676 · 166618530@qq.com

Terms used on this page · explanations by MedicalUpdates.ai

Computed Tomography: An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
immunosuppressive: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
glucocorticoids: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
informed consent form: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Contraindications: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
treatment-naïve: Has not previously received the treatment, or the type of treatment, that the study is about.
primary endpoint: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
endpoints: Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials