Interstitial Lung DiseasesPhase 2NCT07737249
Efficacy and Safety of Golidocitinib for Rapidly Progressive Interstitial Lung Disease
A Phase 2 study testing golidocitinib plus corticosteroid and non-JAK inhibitor immunosuppressant plus corticosteroid in people with Interstitial Lung Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- golidocitinib plus corticosteroid and non-JAK inhibitor immunosuppressant plus corticosteroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib in Rapidly Progressive Interstitial Lung Disease
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:
Read more
- 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
- Being tested
- golidocitinib plus corticosteroid, non-JAK inhibitor immunosuppressant plus corticosteroid
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golidocitinib plus corticosteroidDrug
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.
non-JAK inhibitor immunosuppressant plus corticosteroidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid plus golidocitinib group | Experimental | Not described Receives: Drug: golidocitinib plus corticosteroid |
| Corticosteroid plus non-JAK inhibitor immunosuppressant group | Active comparator | Not described Receives: Drug: non-JAK inhibitor immunosuppressant plus corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in absolute forced vital capacity (FVC) in milliliters (mL) within 12 weeks
Measured: Week 12
Secondary outcomes (8)
Absolute change in FVC % predicted within 12 weeks
Measured: Week 12
Percent change in FVC % predicted within 12 weeks
Measured: Week 12
Absolute change in oxygenation index within 12 weeks
Measured: Week 12
Change in chest CT score within 12 weeks
Measured: Week 12
Proportion of patients requiring invasive respiratory support within 12 weeks
Measured: Week 12
All-cause mortality within 12 weeks
Measured: Week 12
Relapse rate within 12 weeks
Measured: Week 12
Incidence of opportunistic infections within 12 weeks
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737249
- Sponsor's protocol ID
- K11031
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib in Rapidly Progressive Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07737249
- Acronym / sponsor ID
- K11031
- Conditions
- Interstitial Lung Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid plus golidocitinib group | Experimental | Drug: golidocitinib plus corticosteroid |
| Corticosteroid plus non-JAK inhibitor immunosuppressant group | Active comparator | Drug: non-JAK inhibitor immunosuppressant plus corticosteroid |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| golidocitinib plus corticosteroidCorticosteroid 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 | Corticosteroid plus golidocitinib group |
| non-JAK inhibitor immunosuppressant plus corticosteroidCorticosteroid 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. | Drug | Corticosteroid plus non-JAK inhibitor immunosuppressant group |
Primary outcome
Rate of change in absolute forced vital capacity (FVC) in milliliters (mL) within 12 weeks
Time frame: Week 12
8 secondary outcomes
Absolute change in FVC % predicted within 12 weeks
Time frame: Week 12
Percent change in FVC % predicted within 12 weeks
Time frame: Week 12
Absolute change in oxygenation index within 12 weeks
Time frame: Week 12
Change in chest CT score within 12 weeks
Time frame: Week 12
Proportion of patients requiring invasive respiratory support within 12 weeks
Time frame: Week 12
All-cause mortality within 12 weeks
Time frame: Week 12
Relapse rate within 12 weeks
Time frame: Week 12
Incidence of opportunistic infections within 12 weeks
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing golidocitinib plus corticosteroid and non-JAK inhibitor immunosuppressant plus corticosteroid in people with Interstitial Lung Diseases, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Huang (86+13391587917, pumchhh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in absolute forced vital capacity (FVC) in milliliters (mL) within 12 weeks (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.