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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 31, 2027 to May 31, 2027 · Start date changed from estimate of Aug 26, 2025 to Aug 20, 2025 · Site details revisedv3 Show 3 more changesShow less
    • Primary completion date: Mar 31, 2027 to May 31, 2027
    • Start date changed from estimate of Aug 26, 2025 to Aug 20, 2025
    • Site details revised
  2. Start date: May 1, 2025 to Aug 26, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Zurich
157 trials monitored
See 3 trials at risk
Asthma
927 trials monitored
See 32 trials at risk
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 Details
NCT Number NCT06960382
Lead Sponsor University of Zurich
Conditions Allergic Rhinitis, Allergic Asthma
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov