[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypereosinophilic-syndrome-hes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypereosinophilic-syndrome-hes":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100627125","phase-3-roll-over-study-for-participants-who-have-completed-a-previous-clinical-study-with-benralizumab-fasenra-and-benefit-from-continued-treatment-100627125",false,"NCT07444567","Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment","ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment","ROSY-F","Inclusion Criteria:\n\n* 1\\. Provision of signed and dated written ICF.\n\n  2\\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.\n* 3\\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment.\n* 4\\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment.\n* 5\\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.\n\nExclusion Criteria:\n\n* 1\\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab.\n* 2\\. Participants who are planning to use live\u002Flive-attenuated vaccines.\n* 3\\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available.\n* 4\\. Participants with any medical condition (such as cancer or viral infections \\[hepatitis\\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.\n* 5\\. Concurrently enrolled in any clinical study (other than a parent study).\n* 6\\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.\n* 7\\. Local access to commercially available benralizumab.","ALL",{"count":19,"type":20},230,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.",[26,27,28],"Asthma","Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilic Syndrome (HES)",[26,30,28],"Eosinophilic Granulomatosis with Polyangiitis (EGPA)","NOT_YET_RECRUITING","2026-04-07",{"date":34,"type":35},"2026-04-08","ACTUAL",{"date":37,"type":20},"2026-05-25",{"date":39,"type":20},"2029-12-28",{"name":41,"class":42},"AstraZeneca","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100586161","eosinophil-subpopulations-in-eosinophilic-associated-diseases-100586161","NCT06911775","Eosinophil Subpopulations in Eosinophilic-associated Diseases","Exploring Inflammatory and Regulatory Eosinophil Subpopulations: the Path to Precision Medicine for the Treatment of Eosinophilic-associated Diseases","IREOS","Inclusion Criteria:\n\n\\- For inclusion in the study subjects should fulfill the following criteria based on local regulations:\n\nPatients with Asthma, or EGPA or HES:\n\n1. Age between 18 and 75 years at the time of signing the informed consent\n2. Patients with EA, EGPA or HES\n3. Provision of signed and dated written informed consent form prior to any mandatory study procedures, sampling and analysis.\n\nHealthy donors:\n\n1\\. Age between18 and 75 years healthy donors\n\nExclusion Criteria:\n\n* Subjects should not enter the study if any of the following exclusion criteria are fulfilled:\n\n  1. Presence of other chronic pulmonary diseases including COPD\n  2. Presence of other chronic immuno-mediated inflammatory diseases\n  3. Treatment with oral prednisone or equivalent \\> 7.5 mg\u002Fday\n  4. Treatment with long-acting depot corticosteroids in the last three months\n  5. Use of immunosuppressive medications (cyclosporine A; azathioprine; methotrexate; mycophenolate mofetil)\n  6. Receipt of live attenuated vaccines 30 days prior to the enrollment\n  7. Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening\u002Frun-in period.\n  8. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy\n  9. Subjects who are pregnant or breastfeeding\n  10. Current smoking\n  11. Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the investigator may put the patient at risk of his\u002Fher participation in the study, or may influence the results of the study, or the patient\\'s ability to complete entire duration of the study.\n  12. Concurrent enrolment in another interventional or post-authorization safety study.",true,"18 Years","75 Years",{"count":55,"type":20},160,"OBSERVATIONAL","This single-center, non-commercial study will involve 160 participants (80 with eosinophilic asthma (EA), 30 with eosinophilic granulomatosis with polyangiitis (EGPA), 25 with hypereosinophilic syndrome (HES), and 25 healthy donors) to investigate eosinophil subpopulations in these diseases. The study will run from Q4 2024 to Q4 2026.\n\nObjectives:\n\nPrimary: To verify two eosinophil subpopulations (iEos and rEos) in EGPA and HES and analyze the role of type 2 cytokines on their plasticity.\n\nSecondary: Compare iEos proportion between different eosinophilic diseases and correlate with disease severity.\n\nExploratory: Assess the effect of mepolizumab on eosinophil subpopulations in vitro.\n\nPopulation: Adults aged 18-75 with EA, EGPA, or HES, and healthy controls. EA patients must have \\>300 eosinophils\u002FmcL, EGPA requires asthma + eosinophilia + other specific features, and HES requires high eosinophil counts (\\>1500 cells\u002FmL).\n\nMethods: Data will be analyzed using Mann-Whitney U, ANOVA, and Spearman correlation tests, with results presented as mean ± SEM.\n\nThis study will help explore eosinophil behavior in eosinophilic diseases and evaluate mepolizumab's effects on these cells.",[59,27,28],"Eosinophilic Asthma",[61,62,63,64,65,66,67,68,69,70],"Eosinophils","EGPA","HES","EA","Eosinophilic asthma","Eosinophil subpopulations","Flowcytometry","Biomarker","Asthma severity","EGPA severity","2025-03-27",{"date":73,"type":35},"2025-04-04",{"date":75,"type":20},"2025-04",{"date":77,"type":20},"2026-12",{"name":79,"class":80},"University of Florence","OTHER"]