[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632689":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":30,"responsibleParty":49,"collaborators":30,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":30,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":72,"whyStopped":30,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":30},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment arm A","EXPERIMENTAL","CHF10067 (Test Dose 1)",[13],"Drug: CHF10067",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment arm B","CHF10067 (Test Dose 2)",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Treatment arm C","PLACEBO_COMPARATOR","Placebo",[23],"Other: Placebo",[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","CHF10067","Dose 1 CHF10067 Intravenous infusion",[9],null,{"type":26,"name":27,"description":32,"armGroupLabels":33,"otherNames":30},"Dose 2 CHF10067 Intravenous infusion",[15],{"type":35,"name":21,"description":36,"armGroupLabels":37,"otherNames":30},"OTHER","Placebo Intravenous infusion",[19],[39],{"name":40,"affiliation":41,"role":42},"Vincent COTTIN","Louis Pradel Hospital - Lyon, FRANCE","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Chiesi Clinical Trial Info","CONTACT","+ 39 0521 2791","Clinicaltrials_info@chiesi.com",{"type":50,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100632689","phase-2-a-study-to-find-an-efficacious-and-safe-dose-of-chf10067-zampilimab-in-participants-with-idiopathic-pulmonary-fibrosis-100632689",false,"NCT07516951","A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis","A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab), With an Optional 24-week Double Blind, Placebo Controlled Extension Phase in Participants With Idiopathic Pulmonary Fibrosis","ZAPPHIRE","Inclusion Criteria:\n\n* Informed consent: Participant's written informed consent obtained prior to any study-related procedure.\n* Sex and age: Male or female, of any race and ethnicity, aged ≥40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator.\n* Body weight ≥45 kg.\n* Diagnosis of IPF: Diagnosis as defined by the 2018 and 2022 American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Society Guidelines for a maximum 8 years before screening. The most recent HRCT(High-resolution computed tomography) ≤6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis.\n* Lung function: Forced vital capacity (FVC) ≥45% of predicted normal value and a ratio of forced expiratory volume in the first second\u002FFVC ≥0.7 at screening.\n* Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.\n* Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation \\[SpO2\\]) \\>90% at rest when the maximum oxygen flow is 4 L\u002Fmin by standard nasal cannula or the equivalent oxygen delivery via reservoir nasal cannula (≤2 L\u002Fmin).\n\nExclusion Criteria:\n\n* Participant with a documented diagnosis of coeliac disease.\n* Low respiratory tract infection: Documented low respiratory tract infection in the last 4 weeks prior to screening or documented acute exacerbation of IPF (defined as acute worsening or development of dyspnoea typically \\\u003C1 month duration;\n* Lung cancer: Active diagnosis or history of lung cancer.\n* Emphysema: HRCT (refer to inclusion criterion #5 \\[Diagnosis of IPF\\]), reviewed by central reading, shows the presence of emphysema ≥20% or that the extent of emphysema is greater than the extent of fibrosis.\n* Organ transplantation: End-stage fibrotic disease expected to require organ transplantation within 6 months from screening.\n* Other medical conditions: Clinically relevant and uncontrolled pulmonary (including any non-IPF pulmonary diagnosis), cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, psychiatric disorders, active or untreated latent tuberculosis\u002Ftuberculosis infection that may interfere with the participant's ability to complete this study according to the Investigator's judgement.\n* Any other comorbid non-IPF pulmonary condition that may impact FVC according to the Investigator's judgement. Emphysema is allowed, unless it meets the above exclusion criterion regarding emphysema.\n* Participant currently treated, or been treated with cytotoxic and immunosuppressant\u002Fmodulator drugs within 48 weeks prior to screening. Systemic (IV, intramuscular, or oral) corticosteroids prednisone- equivalent dose of \\>10 mg\u002Fday used for \\>10 days.\n* Hypersensitivity: Known intolerance and\u002For hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.\n* History of allergic or anaphylactic reaction to human, humanised, chimeric Igs (immunoglobulins), or murine monoclonal antibodies.","ALL","40 Years",{"count":62,"type":63},240,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 (Part A) of 2 doses of CHF10067 (zampilimab), with an optional 24-week double-blind, placebo-controlled extension phase (Part B) in participants with idiopathic pulmonary fibrosis.\n\nIt is a phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study.\n\nA total of 240 participants with IPF (Idiomatic Pulmonary Fibrosis) will be randomised in approximately 150 investigational sites in North and Latin America, Europe, Asia, and Oceania. The optional extension phase (Part B) is only applicable to the European Union and Macedonia.",[69],"Idiopathic Pulmonary Fibrosis",[71],"IPF","NOT_YET_RECRUITING","2026-04-01",{"date":75,"type":76},"2026-04-08","ACTUAL",{"date":78,"type":63},"2026-06-01",{"date":80,"type":63},"2028-02-12",{"name":5,"class":6}]