Actively Recruiting
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma
Led by University of Zurich · Updated on 2026-03-16
36
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of intralymphatic immunotherapy (ILIT) using ALUTARD SQ Felis domesticus in adults with cat allergy-induced allergic rhinitis and asthma. This study compares ILIT to the traditional subcutaneous immunotherapy (SCIT) to understand its safety, tolerability, immune response, and effectiveness. The trial is designed to provide data for future studies on treatment efficacy, addressing the need for safer allergy treatments with fewer injections. Participants will receive three to four ILIT injections of ALUTARD SQ Felis domesticus directly into an inguinal lymph node, guided by ultrasound. Doses vary across three groups, with injections spaced at least four weeks apart. The total injection volume ranges from 50 to 200 microliters, with doses from 10 to 10,000 SQ units. This method aims to offer a potentially safer alternative to SCIT, which involves many more injections over a longer period. Throughout the study lasting about eight months, participants will undergo safety monitoring including measurements of blood tryptase and assessments according to World Allergy Organization guidelines. They will complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma and treatment effects. Blood samples will be collected for immunological tests, and quality of life assessments will be conducted. Visits last two to three hours, including pre- and post-injection safety follow-up, to carefully track treatment responses and adverse events.
CONDITIONS
Brief Title
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Confirmed cat-dander-induced allergic rhinitis and asthma
- Able and willing to give written informed consent
You will not qualify if you...
- Hypersensitivity to phenol or components of the treatment
- Planned depot steroid injection for allergic rhinitis
- Uncontrolled asthma or lung function (FEV1) less than 70% after treatment
- Severe asthma exacerbation in the past 3 months
- Irreversible lung damage such as emphysema or bronchiectasis
- Chronic obstructive or restrictive lung disease
- Active systemic autoimmune diseases or immune deficiencies
- Severe chronic inflammatory diseases
- Infection with fever or signs of acute or chronic infection at treatment visit
- Malignant tumors with current clinical significance
- Conditions making anaphylactic reactions difficult to treat, including certain heart diseases and use of beta-blockers
- Known cardiovascular disease worse than NYHA class I
- Use of ACE-blockers
- Recent or ongoing liver or kidney disease
- Severe chronic kidney failure due to aluminium burden
- Alcohol or drug abuse
- Pregnant or breastfeeding women
- Women of childbearing age who wish to become pregnant or do not use contraception
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational drug study within 30 days before or during this study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive three to four intralymphatic injections of the study drug spaced at least 4 weeks apart. Each visit includes the injection procedure supported by sonography and various safety and immunological tests. Visits last 2 to 3 hours including safety follow-up.
3 to 4 visits spaced 4 weeks or more apart (in-person)
Duration - 4 months
Participants are monitored for safety and immunological response up to 4 months after the end of treatment. This includes lung function tests, quality of life questionnaires, and allergen sensitivity assessments.
2 visits after treatment completion (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
P
Pål Johansen, Professor, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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