Tests a cat allergy treatment given into a lymph node in adults with asthma
Tests a cat allergy treatment injected into a lymph node in adults with asthma.
Plain-language title generated from the registry record
Registry title: Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Key facts
- Where
- Zurich, SwitzerlandSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06960382, who can take part
Where in Switzerland
- University Hospital ZurichZurich, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Zurich
- Trial code
- NCT06960382
- Record updated
- 16 March 2026
- Original description
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:Read full original descriptionShow less
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma
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:
Is ILIT with ALUTARD SQ Felis domesticus safe and well tolerated?
What immunological responses play a role in ILIT?
Researchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy.
Participants will:
Receive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound.
Undergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement.
Complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy.
Provide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA.
Inclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma.
Exclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 < 70%), recent severe asthma exacerbations, or serious comorbidities.
The study aims to generate data to inform future efficacy trials.
Inclusion: Informed consent as documented by signature; Cat-dander-induced ARC as confirmed by patient history and type-1-sensitization to cat dander in skin and/or serum.
Exclusion: Planned depot steroid injection for treatment of ARC; Patients with uncontrolled asthma or FEV1 < 70% of the predicted value in adults (after adequate pharmacological therapy); Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment visit; Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers); Alcohol or drug abuse; Participation in another study with investigational drug within the 30 days preceding and during the present study; Hypersensitivity to phenol; Chronic obstructive or restrictive lung disease; Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses; Severe chronic inflammatory diseases; Chronic obstructive or restrictive lung disease; Patients with malignant tumours that currently have clinical significance; Known cardiovascular disease, i.e., not even NYHA class I; Recent or on-going hepatic or renal disease; Severe chronic renal insufficiency (due to aluminium burden); Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant; Women of childbearing age who wish to become pregnant or do not use contraception; Patients with a severe asthma exacerbation in the past 3 months; Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis); Use of ACE-blockers; Women who are pregnant and breast feeding.