[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632852":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":39,"locations":11,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":11},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HSK44459","EXPERIMENTAL",null,[13],"Drug: HSK44459",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24,27,30,33,36],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","HSK44459 Without IPF background therapy",[9],{"type":21,"name":9,"description":25,"armGroupLabels":26,"otherNames":11},"HSK44459 With Nintedanib",[9],{"type":21,"name":9,"description":28,"armGroupLabels":29,"otherNames":11},"HSK44459 With Pirfenidone",[9],{"type":21,"name":15,"description":31,"armGroupLabels":32,"otherNames":11},"Placebo Without IPF background therapy",[15],{"type":21,"name":15,"description":34,"armGroupLabels":35,"otherNames":11},"Placebo With Nintedanib",[15],{"type":21,"name":15,"description":37,"armGroupLabels":38,"otherNames":11},"Placebo With Pirfenidone",[15],[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Zuojun Xu, PhD","CONTACT","+86-010-69156114","xuzj@hotmail.com",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632852","phase-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-100632852",false,"NCT07519070","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","Inclusion Criteria:\n\n1. Age ≥40 years, regardless of gender;\n2. Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS\u002FERS\u002FJRS\u002FALAT guidelines (Appendix 1);\n3. Patients must meet one of the following criteria:\n\n   1. 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;\n   2. 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\\];\n4. Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;\n5. Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and \\\u003C90% at screening \\[\\*hemoglobin (Hb)-adjusted\\];\n6. Willing to participate and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Clinically significant airway obstruction during screening \\[pre-bronchodilator forced expiratory volume in 1 second\u002Fforced vital capacity (FEV1\u002FFVC) \\\u003C0.7\\];\n2. Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);\n3. Acute IPF exacerbation within 3 months before screening and\u002For during screening;\n4. Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone \\>15 mg\u002Fday (or equivalent);\n5. History of vasculitis;\n6. Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts\u002Fbehaviors);\n7. Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before\u002Fduring screening (active suicidal thoughts with method\u002Fintent but no plan, or with method\u002Fintent\u002Fplan);\n8. Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before\u002Fduring screening;\n9. Major surgery within 3 months before screening or planned during the study (investigator-assessed; lung transplant listing excluded);\n10. Malignancy within 5 years before screening (except treated basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ);\n11. Blood pressure ≥160\u002F100 mmHg at screening;\n12. Unstable\u002Fworsening cardiovascular\u002Fcerebrovascular disease within 6 months before screening (e.g., unstable angina, myocardial infarction, heart failure, thromboembolic events including stroke\u002FTIA);\n13. Aspartate transaminase (AST) or alanine transaminase (ALT) \\>2.5×ULN or total bilirubin \\>1.5×ULN at screening;\n14. Estimated glomerular filtration rate (eGFR) ≤30 mL\u002Fmin\u002F1.73 m² at screening;\n15. Gastrointestinal surgery\u002Fdisease affecting pharmacokinetics (PK) (except appendectomy\u002Fhernia repair);\n16. Active hepatitis B \\[HBsAg-positive with HBV-DNA above ULN\\], hepatitis C antibody-positive, syphilis (anti-TP-positive with TRUST above ULN), or HIV infection (anti-HIV-positive) at screening;\n17. Current treated liver disease with Child-Pugh A\u002FB\u002FC impairment at screening;\n18. Substance abuse, drug use, or excessive alcohol intake (\\>2 units\u002Fday; 1 unit=360 mL beer \\[5%\\], 45 mL spirits \\[40%\\], or 150 mL wine) within 3 months before screening;\n19. Tobacco\u002Fnicotine product use within 3 months before screening or unwillingness to abstain during the study;\n20. Previous HSK44459 use or PDE1\u002F3\u002F4\u002F10\u002Fnon-selective PDE inhibitor treatment (excluding HSK44459, e.g., apremilast, roflumilast, ibudilast) within 8 weeks before screening;\n21. Use of strong CYP3A4 inhibitors\u002Finducers within 14 days or 5 half-lives (whichever longer) before first dose, or anticipated need during the study;\n22. History of severe drug allergy or hypersensitivity to investigational product\u002Fexcipients;\n23. Participation in other clinical trials (receiving investigational drug\u002Fplacebo) within 1 month before screening;\n24. Pregnancy\u002Flactation; participants of childbearing potential unwilling to use contraception during and for 3 months post-study (including male participants);\n25. Any other investigator-determined factors making participation unsuitable.","ALL","40 Years",{"count":56,"type":57},420,"ESTIMATED","INTERVENTIONAL",[60],"PHASE3","This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).",[63],"IPF","NOT_YET_RECRUITING","2026-03-31",{"date":67,"type":68},"2026-04-09","ACTUAL",{"date":70,"type":57},"2026-04-05",{"date":72,"type":57},"2028-12-30",{"name":5,"class":6}]