Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma

Launched by UNIVERSITY OF ZURICH · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called intralymphatic immunotherapy (ILIT) for people who are allergic to cats and may also have asthma. The researchers want to find out if this treatment, which involves injecting a medicine called ALUTARD SQ Felis domesticus into a lymph node (a part of the immune system), is safe and well tolerated. They will compare the effects of this new method with existing treatments that involve injections under the skin. Participants will receive 3-4 injections and will be monitored for any side effects, as well as their lung function and allergic reactions.

To be eligible for the trial, participants need to be adults aged 18 to 65 who have a confirmed allergy to cat dander and may have asthma. Some people may not qualify, such as those with uncontrolled asthma or certain health conditions. Those who join the study can expect regular check-ins to monitor their health, and they will provide blood samples to help researchers understand how their immune system responds to the treatment. This trial aims to gather important information that could help improve allergy treatments in the future.

Gender

ALL

Eligibility criteria

• 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.