[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577673":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":21,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":21,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":21,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":21,"overallStatus":71,"whyStopped":21,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"therapy group","EXPERIMENTAL","Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily",[13,14],"Biological: Stapokibart","Drug: Mometasone Furoate Nasal Spray (MFNS)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Stapokibart","Stapokibart subcutaneously every two weeks",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Mometasone Furoate Nasal Spray (MFNS)","mometasone furoate nasal spray 200 μg once daily",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Chengshuo Wang","CONTACT","+86-13911623569","wangcs830@126.com",[34],{"facility":35,"status":21,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing Tongren Hospital, Capital Medical University","Beijing","Beijing Municipality","100000","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},{"type":50,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100577673","phase-4-a-cohort-study-on-biomarkers-to-predict-the-efficacy-of-biologics-for-chronic-rhinosinusitis-with-nasal-polyps-100577673",false,"NCT06801353","A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps","Inclusion Criteria:\n\n1. Age 18-75 years old.\n2. With bilateral chronic rhinosinusitis with nasal polyposis.\n3. Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.\n4. Nasal congestion score ≥2 at baseline.\n5. Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and\u002For have contraindications or intolerance to SCS treatment, and\u002For received surgical for nasal polyps more than 6 months before screening.\n6. Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening.\n7. Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening.\n8. Good adherence.\n\nExclusion Criteria:\n\n1. Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives \\[whichever is longer\\] before baseline).\n2. Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).\n3. Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.\n4. Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.\n5. Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening\u002Frun-in period.\n6. Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components.\n7. Concomitant with other poorly controlled serious diseases or recurrent chronic diseases.\n8. Women who are pregnant, breastfeeding, or planning either during the study.","ALL","18 Years","75 Years",{"count":61,"type":62},90,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.",[68,69,70],"Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)","Biological Therapy","Biomarkers","NOT_YET_RECRUITING","2025-02-05",{"date":74,"type":75},"2025-02-06","ACTUAL",{"date":77,"type":62},"2025-02-01",{"date":79,"type":62},"2026-07-01",{"name":5,"class":6},1]