Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
March 16, 2026
March 1, 2026
1.8 years
March 25, 2025
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
From enrollment to the end of treatment at 8 monts. At Baseline, 2 hours after the first Injection and within 1 hour in case of systemic allergic reactions.
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.
From enrollment to the end of treatment at 8 months.
Secondary Outcomes (14)
Effect on phenotype and reactivity of cat-allergen-specific lymphocytes measuring basophil activation to cat allergen
From enrollment to the end of treatment at 8 months.
Change in total IgE concentration from baseline to each injection, 1 and 4 months after the end of treatment
From enrollment to the end of treatment at 8 months.
Change in cat allergen-specific IgE from baseline to each injection and 1 and 4 months after the end of treatment
From enrollment to the end of treatment at 8 months.
Change in cat allergen-specific IgG4 from baseline to each injection, 1 and 4 months after the end of treatment
From enrollment to the end of treatment at 8 months
Change in cat allergen-specific IgG from baseline to each injection, 1 and 4 months after the end of treatment
From enrollment to the end of treatment at ca. 8 months
- +9 more secondary outcomes
Study Arms (3)
ALUTARD SQ® Felis domesticus, Fix dose: 1000 SQ
ACTIVE COMPARATORPatients will get 3 injections of each 1000 SQ contained in each 0.1 mL
ALUTARD SQ® Felis domesticus, Dose escalation: low dose and volume
ACTIVE COMPARATORPatients will get 3 injections with 100, 1000 and finally 10000 SQ contained in each 0.1 mL
Dose escalation: high dose and volume
ACTIVE COMPARATORPatients will get 3 injections 200, 2000 and finally 10000 SQ contained in 0.2, 0.2 and finally 0.1 mL
Interventions
The drug is approved for use in Switzerland for subcutaneous injections. I this study, we will test the intralympahtic injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, 8091, Switzerland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2025
First Posted
May 7, 2025
Study Start
August 20, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Summary of data upon analysis will be shared upon termination of the study. Protocols may be shared during the study upon contact with P or sponsor. Study and data will be published upon termination of the study.