Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Recruiting · NCT06960382 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Zurich
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Hypersensitivity to phenol.
- 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).
- Patients with a severe asthma exacerbation in the past 3 months.
- Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).
- Chronic obstructive or restrictive lung disease.
- Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.
- Severe chronic inflammatory diseases.
- Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment visit.
- Chronic obstructive or restrictive lung disease
- Patients with malignant tumours that currently have clinical significance.
- Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).
- Known cardiovascular disease, i.e., not even NYHA class I.
- Use of ACE-blockers.
- Recent or on-going hepatic or renal disease.
- Severe chronic renal insufficiency (due to aluminium burden).
- Alcohol or drug abuse
- Women who are pregnant and breast feeding
- Women of childbearing age who wish to become pregnant or do not use contraception.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
Where it is running
1 location listed.
- University Hospital Zurich - Zurich, Switzerland