Efficacy and Safety of Golidocitinib for Rapidly Progressive Interstitial Lung Disease | NCT07737249

NCT07737249

Overview

NCT ID: NCT07737249
Lead Sponsor: Peking Union Medical College HospitalOTHER
Official Title: A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib in Rapidly Progressive Interstitial Lung Disease
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Aug 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Hui HuangContact
pumchhh@126.com86+13391587917

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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