[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648258":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":71,"collaborators":32,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":32,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":32,"enrollmentInfo":82,"targetDuration":32,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":93,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shanghai Ark Biopharmaceutical Co., Ltd.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"AK3280 400 mg BID","EXPERIMENTAL","During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner.",[13],"Drug: AK3280",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","During the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner.",[19],"Drug: Placebo",{"label":21,"type":22,"description":23,"interventionNames":24},"Pirfenidone 600 mg TID","ACTIVE_COMPARATOR","During the randomized controlled treatment study, participants will receive pirfenidone titrated gradually to 600 mg three times daily in an open-label manner.",[25],"Drug: Pirfenidone",[27,33,36],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","AK3280","Participants will receive AK3280 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.",[9],null,{"type":28,"name":15,"description":34,"armGroupLabels":35,"otherNames":32},"Participants will receive placebo matching 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.",[15],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":32},"Pirfenidone","Participants will receive pirfenidone three times daily, within 30 minutes after meals. Initial dosing should be titrated gradually under doctor guidance: start with 200 mg each time, increase by 200 mg each time to maintain final dose of 600 mg each time within 2 weeks.",[21],[41],{"name":42,"affiliation":32,"role":43},"Zhen Fu, Medical Director","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":49},"Jayson Zhou","CONTACT","+8618796252099","jayson.zhou@arkbiosciences.com",[51],{"facility":52,"status":32,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"China-Japan Friendship Hospital","Beijing","Beijing Municipality","100029","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65,69],{"name":66,"role":47,"phone":67,"phoneExt":32,"email":68},"Huaping Dai","+861084205566","daihuaping@ccmu.edu.cn",{"name":66,"role":70,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":72,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100648258","phase-3-a-phase-3-study-of-efficacy-and-safety-of-ak3280-in-patients-with-idiopathic-pulmonary-fibrosis-100648258",false,"NCT07719023","A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Age ≥ 40 years at enrolment\n2. Diagnosis of IPF per ATS\u002FERS\u002FJRS\u002FALAT 2022 guidelines\n3. HRCT central review completed during screening or within 12 months prior to screening. If participant did not undergo lung surgical biopsy, HRCT imaging must be consistent with usual interstitial pneumonia (UIP) pattern for definitive IPF diagnosis.\n4. No prior anti-fibrotic treatment, or discontinued anti-fibrotic therapy for ≥4 weeks or 5 half-lives (whichever is longer) prior to randomization\n5. Screening assessments meeting all of the following: 1) Standardized %pFVC ≥ 50% and ≤ 90%；2) Hemoglobin-corrected %pDLco ≥ 30% and ≤ 90%；3) Resting SpO2 ≥ 88%\n\nExclusion Criteria:\n\n1. History of hypersensitivity to pirfenidone or AK3280\n2. Known intolerance to pirfenidone single dose of 200 mg (total daily dose 600 mg)\n3. Hospitalization due to acute IPF exacerbation within 8 weeks prior to screening or during screening\n4. Within 4 weeks prior to screening or during screening, local or systemic infection requiring: 1) Hospitalization ≥ 24 hours; or 2) Use of systemic antibiotics (IV, IM, oral, or inhaled)\n5. History of active tuberculosis within 12 months prior to screening\n6. History of other clinically significant lung diseases besides IPF (e.g., asthma, COPD, interstitial pneumonia of known cause, acute severe pulmonary infection, etc.), or planned lung transplantation within 6 months after signing informed consent\n7. Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7 or positive bronchodilator response (defined as ≥ 12% relative increase in FEV1 and ≥ 200 mL absolute increase in FEV1 after bronchodilator use) during screening\n8. History of heart disease meeting NYHA Class III-IV\n9. History of liver cirrhosis, severe hepatic impairment, or end-stage liver disease\n10. Screening liver function abnormalities meeting any of the following:1) AST ≥ 2× ULN; 2) ALT ≥ 2× ULN; 3) ALP ≥ 2× ULN; 4) Total bilirubin ≥ 1.5× ULN\n11. Screening cystatin C-estimated eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m²\n12. Screening coagulation test meeting any of the following: 1) INR \\> 2; 2) Both PT and APTT prolonged \\> 1.5× ULN\n13. History of any clinically diagnosed autoimmune disease, including but not limited to scleroderma, polymyositis\u002Fdermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis\n14. Uncontrolled diabetes during screening (HbA1c \\> 10%)\n15. History of malignancy or possible malignancy upon evaluation (except treated localized basal cell carcinoma of the skin or cervical carcinoma in situ without recurrence)\n16. History of immunodeficiency, including but not limited to HIV infection\n17. History of any disease other than IPF with life expectancy \\\u003C 18 months; or requiring long-term medical care, or limited self-care ability; or conditions that the investigator believes may affect participant's ability to complete this clinical study, complete study-related assessments, or affect safety or efficacy assessments\n18. Use of prohibited medications with potential effects on efficacy endpoints within 4 weeks or 5 half-lives (whichever is longer) prior to randomization","ALL","40 Years",{"count":83,"type":84},263,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","This is a phase 3 clinical study conducted in China. The primary objective is to compare the efficacy and safety of AK3280 400 mg versus placebo and active control (pirfenidone) in IPF patients.",[90],"Idiopathic Pulmonary Fibrosis (IPF)",[29,92,37],"IPF","NOT_YET_RECRUITING","2026-07-17",{"date":96,"type":97},"2026-07-22","ACTUAL",{"date":99,"type":84},"2026-08-31",{"date":101,"type":84},"2029-03-31",{"name":5,"class":6},1]