Immunotherapy for Cat Allergy by Injecting Allergen into the Lymph Node: Safety and Effects on the Immune System
Descrizione riassuntiva dello studio
Cat (hair) allergies are often difficult to treat and significantly affect those affected, as the allergens are hard to avoid. The only approved way to treat the allergy itself is currently subcutaneous immunotherapy. In this treatment, patients are "desensitized" to the allergen by injecting it under the skin in a low, gradually increasing dose. However, individuals with cat allergies often experience side effects during this treatment. A form of immunotherapy that has only been studied so far is called intralymphatic immunotherapy, where the allergen is injected directly into a lymph node under ultrasound control. This directly targets certain immune system cells. Fewer injections are needed compared to subcutaneous immunotherapy, and fewer side effects are expected. This therapy has already been applied in studies with various allergens and showed positive results, although it has been tested on relatively few patients so far. In this study, we aim to investigate whether intralymphatic immunotherapy is well tolerated and safe for cat allergy and whether it shows effects on cat allergy. In the first phase of the study, a well-tolerated and safe dose for the therapy will be determined, and in the second phase, the therapy will be conducted in three different treatment groups. These differ in the dosage of intralymphatic immunotherapy. The treatment will last for three months, followed by a follow-up phase of another three months.
(BASEC)
Intervento studiato
Intralymphatic immunotherapy (immunotherapy by injecting the allergen into the lymph node)
(BASEC)
Malattie studiate
Cat (hair) allergy
(BASEC)
Cat allergy (BASEC)
Criteri di esclusione
severe, uncontrolled asthma pregnancy chronic inflammatory or malignant diseases (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Professor Pål Johansen, Universitätsspital Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
ILIT-Studienteam (Claudia Lang, Alexandra Steiger)
+41 (0)43 253 7855
ilit-studie@clutterusz.chDermatologische Klinik, Universitätsspital Zürich
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
16.05.2025
(BASEC)
ID di studio ICTRP
NCT06960382 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Safety and immunogenicity of cat-allergen intralymphatic immunotherapy: an open label Phase II study in patients with cat allergy with and without asthma (BASEC)
Titolo accademico
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma (ICTRP)
Titolo pubblico
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma (ICTRP)
Malattie studiate
Allergic RhinitisAllergic Asthma (ICTRP)
Intervento studiato
Drug: ALUTARD SQ Felis domesticus (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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. (ICTRP)
non disponibile
Endpoint primari e secondari
Change of blood tryptase levels at baseline, after first ILIT and in case of systemic allergic reactions;Incidence and severity of adverse events using the WAO rating system 2024 (ICTRP)
Effect on phenotype and reactivity of cat-allergen-specific lymphocytes measuring basophil activation to cat allergen;Change in total IgE concentration from baseline to each injection, 1 and 4 months after the end of treatment;Change in cat allergen-specific IgE from baseline to each injection and 1 and 4 months after the end of treatment;Change in cat allergen-specific IgG4 from baseline to each injection, 1 and 4 months after the end of treatment;Change in cat allergen-specific IgG from baseline to each injection, 1 and 4 months after the end of treatment;Assessment of treatment benefit by calculating the ratio of cat allergen-specific IgG4 to IgE;Change in skin sensitivity by measuring the diameters in Skin Prick Test (SPT) at baseline and 4 months after treatment;Change in spirometry from baseline and 4 months after end of treatment;Change of Fraction Exspiratory Nitric Oxide (FeNo) from baseline to 4 months after end of treatment;Efficacy assessment using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ);Efficacy assessment using Asthma Quality of Life Questionnaire (AQLQ);Change in leukotriene release of blood cells from baseline to each injection and 1 and 4 months after the end of treatment;Change of rhinal secretion by using the Schirmer Test after nasal provocation test (NPT) at baseline and 4 months after end of treatment.;Change of nasal reactivity by rhinoscopic assessment before and after nasal provocation test (NTP) at baseline and 4 months after end of treatment (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Pl Johansen, Professor, PhDClaudia V.L. Lang, MD, pal.johansen@usz.chclaudia.lang@usz.ch, +41 44 255 8616+41 43 253 7855 (ICTRP)
ID secondari
CAT-ILIT-USZ-25/1 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06960382 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile