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

NCT06960382 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis
  • Allergic Asthma

Interventions

DRUG

ALUTARD SQ® Felis domesticus

The drug is approved for use in Switzerland for subcutaneous injections. I this study, we will test the intralympahtic injection

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2027-05-31
Completion
2028-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960382 on ClinicalTrials.gov