Efficacy and Safety of Golidocitinib for Rapidly Progressive Interstitial Lung Disease

NCT07737249 | Not Yet Recruiting Phase 2

• 1 other identifier: K11031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of change in absolute forced vital capacity (FVC) in milliliters (mL) within 12 weeks

  Week 12

Secondary Outcomes (8)

• Absolute change in FVC % predicted within 12 weeks

  Week 12

• Percent change in FVC % predicted within 12 weeks

  Week 12

• Absolute change in oxygenation index within 12 weeks

  Week 12

• Change in chest CT score within 12 weeks

  Week 12

• Proportion of patients requiring invasive respiratory support within 12 weeks

  Week 12

Study Arms (2)

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

Interventions

golidocitinib plus corticosteroid DRUG

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.

Corticosteroid plus golidocitinib group

non-JAK inhibitor immunosuppressant plus corticosteroid DRUG

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.

Corticosteroid plus non-JAK inhibitor immunosuppressant group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Hui Huang

CONTACT

86+13391587917; pumchhh@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)