Efficacy and Safety of Golidocitinib for Rapidly Progressive Interstitial Lung Disease

Starting soon · Phase 2

Conditions studied: Interstitial Lung Diseases

In brief

The goal of this clinical trial is to learn whether adding the JAK inhibitor golidocitinib to standard corticosteroid therapy works to treat rapidly progressive interstitial lung disease (RP-ILD) in patients with acute worsening. It will also learn about its safety compared to standard treatment without JAK inhibitors (i.e., corticosteroids plus other immunosuppressants such as mycophenolate mofetil, tacrolimus, cyclophosphamide, or biologics). The main questions it aims to answer are: * How much does the addition of golidocitinib improve lung function, measured by the absolute change in FVC (mL), after 12 weeks of treatment? * How does it compare to standard therapy in terms of changes in FVC% predicted, oxygenation index, chest CT score, need for invasive respiratory support, all-cause mortality, relapse rate, and incidence of opportunistic infections? Researchers will compare the golidocitinib group (golidocitinib 150 mg once daily plus corticosteroids) to the control group (corticosteroids plus non-JAK inhibitor immunosuppressants). All patients receive high-dose corticosteroids (prednisone equivalent ≥1 mg/kg/day) with a tapering regimen. Participants will: * Receive either golidocitinib plus corticosteroids or control treatment for 12 weeks * Visit the clinic for check-ups, blood tests, and lung function tests at weeks 1, 2, 4, 6-8, and 12 * Have chest high-resolution CT scans at weeks 2, 4-6, and 12 to monitor disease progression * Be monitored for adverse events and efficacy outcomes throughout the 12-week period

Key facts

Study ID: NCT07737249
Run by: Peking Union Medical College Hospital
People needed: 60
Starts: 2026-09-01
Expected to finish: 2027-08-31
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years
Meet the diagnostic criteria for rapidly progressive interstitial lung disease (RP-ILD) and require treatment with corticosteroids and immunosuppressants, defined as: Acute worsening of cough and dyspnea occurring within 1 month; Chest CT showing ILD manifestations with new or worsening exudative lesions (ground-glass opacities and/or consolidation); Presence of respiratory failure (PaO₂ < 60 mmHg at rest without oxygen supplementation, or SpO₂ < 90% on room air), or significant worsening of hypoxemia (a decrease in PaO₂ of ≥ 10 mmHg), or a clear decline in two recent pulmonary function tests: a decrease in FVC % predicted of ≥ 10% and/or a decrease in DLCO % predicted of ≥ 15% accompanied by a decline in FVC; Exclusion of heart failure or fluid overload, pulmonary infectious diseases, and pulmonary embolism
No prior treatment with JAK inhibitors
Able to comply with scheduled follow-up visits
Patient and family members understand the study protocol, are willing to participate, and are able to provide written informed consent.

You may not qualify if…

The patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide informed consent
Subjects who are unable to comply with the follow-up schedule as required by the protocol, including those who cannot cooperate with pulmonary function testing
Presence of other severe diseases that, in the investigator's opinion, may affect patient safety or compliance
Any significant clinical or laboratory abnormalities that, in the investigator's opinion, may affect the safety evaluation
Oxygenation index ≤ 100, and/or requirement for invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) support
Pregnant or lactating women, as well as patients who are unable to use effective contraception during the study period and within 3 months after the end of the study
Presence of contraindications to golidocitinib administration, including a history of allergy to relevant drugs, or presence of active and uncontrolled infections, such as evidence of HIV, HBV (HBsAg-positive, HBV-DNA-positive or ≥ 1000 copies/mL), HCV (anti-HCV antibody-positive or HCV-RNA-positive), or any symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment
Need for concomitant use of acetaminophen or propacetamol, or preparations containing these ingredients

Where it is running

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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