Not Yet RecruitingPhase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis

420 participantsStarted 2026-04-05

Plain-language summary

This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥40 years, regardless of gender;
✓. Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);
✓. Patients must meet one of the following criteria:
✓. No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;
✓. On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. \[Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events\];
✓. Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;
✓. Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and \<90% at screening \[\*hemoglobin (Hb)-adjusted\];
✓. Willing to participate and voluntarily sign the informed consent form.

✕. Clinically significant airway obstruction during screening \[pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7\];
✕. Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);
✕. Acute IPF exacerbation within 3 months before screening and/or during screening;
✕. Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone \>15 mg/day (or equivalent);
✕. History of vasculitis;
✕. Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviors);
✕. Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before/during screening (active suicidal thoughts with method/intent but no plan, or with method/intent/plan);
✕. Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before/during screening;

Change in FVC from baseline at Week 52

Timeframe: Week 52

NCT IDNCT07519070

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-05

Zuojun Xu, PhD

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥40 years, regardless of gender;
✓. Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);
✓. Patients must meet one of the following criteria:
✓. No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;
✓. On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. \[Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events\];
✓. Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;
✓. Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and \<90% at screening \[\*hemoglobin (Hb)-adjusted\];
✓. Willing to participate and voluntarily sign the informed consent form.

✕. Clinically significant airway obstruction during screening \[pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7\];
✕. Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);
✕. Acute IPF exacerbation within 3 months before screening and/or during screening;
✕. Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone \>15 mg/day (or equivalent);
✕. History of vasculitis;
✕. Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviors);
✕. Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before/during screening (active suicidal thoughts with method/intent but no plan, or with method/intent/plan);
✕. Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before/during screening;