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Efficacy and Safety of Golidocitinib for Rapidly Progressive Interstitial Lung Disease

NCT07737249 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-30

No results posted yet for this study

Summary

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

Conditions

  • Interstitial Lung Diseases

Interventions

DRUG

golidocitinib plus corticosteroid

Corticosteroid regimen: Methylprednisolone 80 mg intravenous infusion twice daily for 7 days, then tapered to 40 mg twice daily for 7 days; subsequently, after 7 days of oral full-dose corticosteroids, the tapering begins with a reduction of 2.5 mg per week until the dose reaches 30 mg daily, after which the dose is reduced by 2.5 mg every 2 weeks until 15 mg daily, and then an individualized tapering schedule is applied according to the patient's clinical condition. Concurrently, golidocitinib 150 mg is taken orally once daily.

DRUG

non-JAK inhibitor immunosuppressant plus corticosteroid

Corticosteroid regimen: Methylprednisolone 80 mg intravenous infusion twice daily for 7 days, then tapered to 40 mg twice daily for 7 days; subsequently, after 7 days of oral full-dose corticosteroids, the tapering begins with a reduction of 2.5 mg per week until the dose reaches 30 mg daily, after which the dose is reduced by 2.5 mg every 2 weeks until 15 mg daily, and then an individualized tapering schedule is applied according to the patient's clinical condition. Non-JAK inhibitor immunosuppressants: such as mycophenolate mofetil, tacrolimus, cyclophosphamide, ciclosporin, rituximab, and tocilizumab, with specific dosages following the routine use of each individual drug.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07737249 on ClinicalTrials.gov