[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589897":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":57,"collaborators":28,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":28,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ALUTARD SQ® Felis domesticus, Fix dose: 1000 SQ","ACTIVE_COMPARATOR","Patients will get 3 injections of each 1000 SQ contained in each 0.1 mL",[13],"Drug: ALUTARD SQ® Felis domesticus",{"label":15,"type":10,"description":16,"interventionNames":17},"ALUTARD SQ® Felis domesticus, Dose escalation: low dose and volume","Patients will get 3 injections with 100, 1000 and finally 10000 SQ contained in each 0.1 mL",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose escalation: high dose and volume","Patients will get 3 injections 200, 2000 and finally 10000 SQ contained in 0.2, 0.2 and finally 0.1 mL",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","ALUTARD SQ® Felis domesticus","The drug is approved for use in Switzerland for subcutaneous injections. I this study, we will test the intralympahtic injection",[15,9,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Pål Johansen, Professor, PhD","CONTACT","+41 44 255 8616","pal.johansen@usz.ch",[36],{"facility":37,"status":38,"city":39,"state":28,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Hospital Zurich","RECRUITING","Zurich","8091","Switzerland","CH",{"type":44,"coordinates":45},"Point",[46,47],8.55,47.36667,{"lat":47,"lon":46},[50,54],{"name":51,"role":32,"phone":52,"phoneExt":28,"email":53},"Carole Guillet, MD","+41 43 253 1063","Carole.Guillet@usz.ch",{"name":55,"role":56,"phone":28,"phoneExt":28,"email":28},"Claudia V.L. Lang, MD","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100589897","phase-1-safety-and-immunogenicity-of-cat-allergen-intralymphatic-immunotherapy-in-patients-with-cat-allergy-with-and-without-asthma-100589897",false,"NCT06960382","Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma","Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma","Inclusion Criteria:\n\n* Informed consent as documented by signature.\n* Cat-dander-induced ARC as confirmed by patient history and type-1-sensitization to cat dander in skin and\u002For serum.\n\nExclusion Criteria:\n\n* Hypersensitivity to phenol.\n* Planned depot steroid injection for treatment of ARC\n* Patients with uncontrolled asthma or FEV1 \\\u003C 70% of the predicted value in adults (after adequate pharmacological therapy).\n* Patients with a severe asthma exacerbation in the past 3 months.\n* Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).\n* Chronic obstructive or restrictive lung disease.\n* Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.\n* Severe chronic inflammatory diseases.\n* Concomitant infection with fever or other signs\u002Fsymptoms of an acute or chronic infection at treatment visit.\n* Chronic obstructive or restrictive lung disease\n* Patients with malignant tumours that currently have clinical significance.\n* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).\n* Known cardiovascular disease, i.e., not even NYHA class I.\n* Use of ACE-blockers.\n* Recent or on-going hepatic or renal disease.\n* Severe chronic renal insufficiency (due to aluminium burden).\n* Alcohol or drug abuse\n* Women who are pregnant and breast feeding\n* Women of childbearing age who wish to become pregnant or do not use contraception.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* Participation in another study with investigational drug within the 30 days preceding and during the present study.","ALL","18 Years","65 Years",{"count":70,"type":71},36,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhinitis and asthma. The main questions it aims to answer are:\n\nIs ILIT with ALUTARD SQ Felis domesticus safe and well tolerated?\n\nWhat immunological responses play a role in ILIT?\n\nResearchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy.\n\nParticipants will:\n\nReceive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound.\n\nUndergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement.\n\nComplete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy.\n\nProvide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA.\n\nInclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma.\n\nExclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 \\\u003C 70%), recent severe asthma exacerbations, or serious comorbidities.\n\nThe study aims to generate data to inform future efficacy trials.",[78,79],"Allergic Rhinitis","Allergic Asthma",[81,82,83,84,85,86],"cat allergy","asthma","rhinitis","immunotherapy","intralymphatic injection","ILIT","2026-03-12",{"date":89,"type":90},"2026-03-16","ACTUAL",{"date":92,"type":90},"2025-08-20",{"date":94,"type":71},"2028-03-31",{"name":5,"class":6},1]