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.
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.
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.
Sequential
ALUTARD SQ® Felis domesticus
DrugThe drug is approved for use in Switzerland for subcutaneous injections. I this study, we will test the intralympahtic injection
Change of blood tryptase levels at baseline, after first ILIT and in case of systemic allergic reactions
The overall objective is to test whether ILIT with a cat hair allergen extract is safe and tolerable in patients with allergy to cat hair allergen. To assess safety, blood tryptase levels (μg/L) are measured at baseline, 2 hours after the first ILIT and within 1 hour in case of systemic allergic reactions in the following ILIT-visits. Tryptase is released during a systemic allergic reaction.
Incidence and severity of adverse events using the WAO rating system 2024
Safety assessment by analyzing allergic reactions and their severity using World Allergy Organization Grading System (WAO 2024). The scale reaches from 0 (no averse events) to 5 (e.g. anaphylaxis or respiratory or cardiac arrest). Higher number indicating higher severity.
Effect on phenotype and reactivity of cat-allergen-specific lymphocytes measuring basophil activation to cat allergen
Immunogenicity will be assessed measuring basophil activation to cat allergen in vitro using CAST ELISA. Using this analysis, the effect on phenotype and reactivity of cat-allergen-specific lymphocyte reactions will be studied.
Change in total IgE concentration from baseline to each injection, 1 and 4 months after the end of treatment
Further the study aims to explore initial knowledge to immunogenicity of ILIT with ALUTARD SQ. Immunogenicity will be assessed measuring total IgE (kU/L) using IMMUNOCAP.
Change in cat allergen-specific IgE from baseline to each injection and 1 and 4 months after the end of treatment
Further the study aims to explore initial knowledge to immunogenicity of ILIT with ALUTARD SQ. Immunogenicity will be assessed measuring cat allergen-specific IgE (kUA/L) using IMMUNOCAP.
Change in cat allergen-specific IgG4 from baseline to each injection, 1 and 4 months after the end of treatment
Immunogenicity will be assessed measuring IgG4 (in μg/L)) using IMMUNOCAP.
Click on the lead sponsor to view all of their trials.
