Allergic RhinitisPhase 1/2NCT06960382
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
A Phase 1/2 study testing ALUTARD SQ® Felis domesticus in people with Allergic Rhinitis and Allergic Asthma, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Asthma
- What is being tested?
- ALUTARD SQ® Felis domesticus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Aug 2025to 31 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Carole Guillet, MD, +41 43 253 1063, Carole.Guillet@usz.ch
Claudia V.L. Lang, MD
About this study
Official title: Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma
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?
Read more
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.
Read the detailed description
Patients with allergic rhinitis and asthma due to sensitisation to cat allergens are seldom offered allergen immunotherapy (AIT) due to risk of systemic allergic adverse events such as asthma exacerbations and anaphylaxis. In Switzerland, ALUTARD SQ Felis domesticus is approved for subcutaneous immunotherapy (SCIT). The treatment comprises nearly 50 injections over 3 years. In contrast, intralymphatic immunotherapy (ILIT) is an experimental treatment option that has been suggested to be effective after only 3-4 injections using much lower doses as for SCIT. Since the lymph nodes do not contains mast cells, and due to the lower doses and less injections, ILIT is expected to be a safer alternative to SCIT. This study in patient with cat allergy therefore tests the safety and tolerability of ALUTARD SQ Felis domesticus in ILIT.
The objective is to test if ILIT is safe and tolerable in patients with allergy to cat hair allergen and to determine which immunological responses play a role in ILIT.
The main outcome measures on the safety, tolerability, immunogenicity and efficacy. The data will be used to design later efficacy studies.
Safety is measured using a World Allergy Organization (WAO) guideline for systemic allergic reactions and by tryptase measurement in blood serum. Effects on asthma is measured using lung functions tests and questionnaires. Immunogenicity is measured by ImmunoCAP and basophil activation is measured using CAST ELISA. Treatment effect is measured using a modified nasal provocation test and quality of life questionnaires.
Inclusion: Informed consent, cat-dander-induced ARC, age 18-65 years, any sex and gender.
Exclusion: Hypersensitivity to aluminium hydroxide or phenol. Systemic steroid treatment. Uncontrolled asthma or FEV1 < 70%. Severe asthma exacerbation last 3 months. Emphysema, bronchiectasis. Serious comorbidities as judged by the recruiting physician.
The study drug is administered by injection into an inguinal lymph node. The targeting of the lymph node is supported by simultaneous sonography.
"ALUTARD SQ Felis domesticus" is administered intralymphatically. The injection volume is 50-200 mcl and the dose is between 10 SQ units and 10,000 SQ units. The injections will be performed three to four times with 4 weeks or more interval between each injection.
The procedures last for 5-10 minutes, but various tests and are performed prior to and after the ILIT injection. The visits therefore last for 2-3 hours, including the safety follow up.
- Conditions
- Allergic Rhinitis, Allergic Asthma
- Being tested
- ALUTARD SQ® Felis domesticus
- Keywords
- cat allergy, asthma, rhinitis, immunotherapy, intralymphatic injection, ILIT
- Medical subject headings
- Rhinitis, Allergic, Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALUTARD SQ® Felis domesticusDrug
The drug is approved for use in Switzerland for subcutaneous injections. I this study, we will test the intralympahtic injection
| Study group | Role | What they receive |
|---|---|---|
| ALUTARD SQ® Felis domesticus, Fix dose: 1000 SQ | Active comparator | Patients will get 3 injections of each 1000 SQ contained in each 0.1 mL Receives: Drug: ALUTARD SQ® Felis domesticus |
| ALUTARD SQ® Felis domesticus, Dose escalation: low dose and volume | Active comparator | Patients will get 3 injections with 100, 1000 and finally 10000 SQ contained in each 0.1 mL Receives: Drug: ALUTARD SQ® Felis domesticus |
| Dose escalation: high dose and volume | Active comparator | Patients will get 3 injections 200, 2000 and finally 10000 SQ contained in 0.2, 0.2 and finally 0.1 mL Receives: Drug: ALUTARD SQ® Felis domesticus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood tryptase levels at baseline, after first ILIT and in case of systemic allergic reactions
The overall objective is to test whether ILIT with a cat hair allergen extract is safe and tolerable in patients with allergy to cat hair allergen. To assess safety, blood tryptase levels (μg/L) are measured at baseline, 2 hours after the first ILIT and within 1 hour in case of systemic allergic reactions in the following ILIT-visits. Tryptase is released during a systemic allergic reaction.
Measured: From enrollment to the end of treatment at 8 monts. At Baseline, 2 hours after the first Injection and within 1 hour in case of systemic allergic reactions.
Incidence and severity of adverse events using the WAO rating system 2024
Safety assessment by analyzing allergic reactions and their severity using World Allergy Organization Grading System (WAO 2024). The scale reaches from 0 (no averse events) to 5 (e.g. anaphylaxis or respiratory or cardiac arrest). Higher number indicating higher severity.
Measured: From enrollment to the end of treatment at 8 months.
Secondary outcomes (14)
Effect on phenotype and reactivity of cat-allergen-specific lymphocytes measuring basophil activation to cat allergen
Immunogenicity will be assessed measuring basophil activation to cat allergen in vitro using CAST ELISA. Using this analysis, the effect on phenotype and reactivity of cat-allergen-specific lymphocyte reactions will be studied.
Measured: From enrollment to the end of treatment at 8 months.
Change in total IgE concentration from baseline to each injection, 1 and 4 months after the end of treatment
Further the study aims to explore initial knowledge to immunogenicity of ILIT with ALUTARD SQ. Immunogenicity will be assessed measuring total IgE (kU/L) using IMMUNOCAP.
Measured: From enrollment to the end of treatment at 8 months.
Change in cat allergen-specific IgE from baseline to each injection and 1 and 4 months after the end of treatment
Further the study aims to explore initial knowledge to immunogenicity of ILIT with ALUTARD SQ. Immunogenicity will be assessed measuring cat allergen-specific IgE (kUA/L) using IMMUNOCAP.
Measured: From enrollment to the end of treatment at 8 months.
Change in cat allergen-specific IgG4 from baseline to each injection, 1 and 4 months after the end of treatment
Immunogenicity will be assessed measuring IgG4 (in μg/L)) using IMMUNOCAP.
Measured: From enrollment to the end of treatment at 8 months
Change in cat allergen-specific IgG from baseline to each injection, 1 and 4 months after the end of treatment
Immunogenicity will be assessed measuring concentration of cat allergen-specific IgG (μg/L) using IMMUNOCAP.
Measured: From enrollment to the end of treatment at ca. 8 months
Assessment of treatment benefit by calculating the ratio of cat allergen-specific IgG4 to IgE
Immunogenicity will be assessed calculating the allergen-specific IgG4 to IgE ratio (μg/kUA). The higher the ratio the greater is the expected benefit of the treatment. Both values will be measured using IMMUNOCAP.
Measured: From enrollment to the end of treatment at 8 months.
Change in skin sensitivity by measuring the diameters in Skin Prick Test (SPT) at baseline and 4 months after treatment
Immunogenicity will be assessed by analyzing the change in skin sensitivity by measuring the diameters at baseline and 16 weeks after treatment as well as the change from baseline.
Measured: From enrollment to the end of treatment at 8 months. At baseline and at 4 months after end of treatment.
Change in spirometry from baseline and 4 months after end of treatment
Immunogenicity will be assessed measuring the lung function with spirometry. The change from baseline to the last follow up 16 weeks after the last treatment will be assessed for each patient and in comparison to the other treatment groups.
Measured: From enrollment to the end of treatment at 8 months. At baseline and 4 months after end of treatment.
Change of Fraction Exspiratory Nitric Oxide (FeNo) from baseline to 4 months after end of treatment
Immunogenicity will be asessed measuring FeNo. The change from baseline and the last follow up 16 weeks after the last ILIT will be assessed for each patient and in comparison to the other treatment groups.
Measured: From enrollment to the end of treatment at 8 months. At baseline and at 4 months after treatment.
Efficacy assessment using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Efficacy will be measured using questionnaires to assess quality of life regarding rhinoconjuctivitis (RQLQ, scale 0-6, 6 indicating severely impaired).
Measured: From enrollment to the end of treatment at 8 months
Efficacy assessment using Asthma Quality of Life Questionnaire (AQLQ)
Efficacy will be measured using questionnaires to assess quality of life regarding asthma (AQLQ, scale 1-7, 1 indicating severely impaired). This measure will only be applied in participants that have a history of asthma.
Measured: From enrollment to the end of treatment at 8 months
Change in leukotriene release of blood cells from baseline to each injection and 1 and 4 months after the end of treatment
Efficacy is will be assessed measuring the release of leukotriene (μg/mL) in a culture of blood cells stimulated with the allergen using CAST ELISA. It will be measured at baseline, each ILIT visit and at the follow up visits 1 and 4 months after end of treatment.
Measured: From enrollment to the end of treatment at 8 months. At baseline, each ILIT injection, 1 and 4 months after 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.
Efficacy will be assessed using the NPT to reflect natural exposure. The change of nasal secretion after provocation with the cat hair allergen is measured using the Schirmer test. 30 seconds after nasal provocation the test strip will be attached to the nasal septum. After 3 minutes rhinal secretion is quantified measuring the running distance of rhinal fluid on the test strip in millimeters. The difference from baseline and 16 weeks after the last ILIT is measured.
Measured: From enrollment to the end of treatment at 8 months. 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
Efficacy will be assessed using a rhinoscopic semi-quantitative evaluation before and after the nasal provocation test (NPT) at the start of the study and 4 months after the end of treatment. Rhinoscopy is used to assess secretion (0 = no secretion, 2 = heavy secretion), irritation (0 = 0-2 sneezes, 2 = >5 sneezes) and distant symptoms (1 = itching in the palate or ear, 2 = conjunctivitis, chemosis, coughing or dyspnoea, urticaria). The test is considered positive if the total score is at least 3 points.
Measured: From enrollment to the end of treatment at 8 months. At baseline and 4 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start20 Aug 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960382
- Sponsor's protocol ID
- CAT-ILIT-USZ-25/1
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary of data upon analysis will be shared upon termination of the study. Protocols may be shared during the study upon contact with P or sponsor. Study and data will be published upon termination of the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma
- ClinicalTrials.gov ID
- NCT06960382
- Acronym / sponsor ID
- CAT-ILIT-USZ-25/1
- Conditions
- Allergic Rhinitis, Allergic Asthma
- Keywords
- cat allergy, asthma, rhinitis, immunotherapy, intralymphatic injection, ILIT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with allergic rhinitis and asthma due to sensitisation to cat allergens are seldom offered allergen immunotherapy (AIT) due to risk of systemic allergic adverse events such as asthma exacerbations and anaphylaxis. In Switzerland, ALUTARD SQ Felis domesticus is approved for subcutaneous immunotherapy (SCIT). The treatment comprises nearly 50 injections over 3 years. In contrast, intralymphatic immunotherapy (ILIT) is an experimental treatment option that has been suggested to be effective after only 3-4 injections using much lower doses as for SCIT. Since the lymph nodes do not contains mast cells, and due to the lower doses and less injections, ILIT is expected to be a safer alternative to SCIT. This study in patient with cat allergy therefore tests the safety and tolerability of ALUTARD SQ Felis domesticus in ILIT.
The objective is to test if ILIT is safe and tolerable in patients with allergy to cat hair allergen and to determine which immunological responses play a role in ILIT.
The main outcome measures on the safety, tolerability, immunogenicity and efficacy. The data will be used to design later efficacy studies.
Safety is measured using a World Allergy Organization (WAO) guideline for systemic allergic reactions and by tryptase measurement in blood serum. Effects on asthma is measured using lung functions tests and questionnaires. Immunogenicity is measured by ImmunoCAP and basophil activation is measured using CAST ELISA. Treatment effect is measured using a modified nasal provocation test and quality of life questionnaires.
Inclusion: Informed consent, cat-dander-induced ARC, age 18-65 years, any sex and gender.
Exclusion: Hypersensitivity to aluminium hydroxide or phenol. Systemic steroid treatment. Uncontrolled asthma or FEV1 < 70%. Severe asthma exacerbation last 3 months. Emphysema, bronchiectasis. Serious comorbidities as judged by the recruiting physician.
The study drug is administered by injection into an inguinal lymph node. The targeting of the lymph node is supported by simultaneous sonography.
"ALUTARD SQ Felis domesticus" is administered intralymphatically. The injection volume is 50-200 mcl and the dose is between 10 SQ units and 10,000 SQ units. The injections will be performed three to four times with 4 weeks or more interval between each injection.
The procedures last for 5-10 minutes, but various tests and are performed prior to and after the ILIT injection. The visits therefore last for 2-3 hours, including the safety follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALUTARD SQ® Felis domesticus, Fix dose: 1000 SQ | Active comparator | Drug: ALUTARD SQ® Felis domesticusPatients will get 3 injections of each 1000 SQ contained in each 0.1 mL |
| ALUTARD SQ® Felis domesticus, Dose escalation: low dose and volume | Active comparator | Drug: ALUTARD SQ® Felis domesticusPatients will get 3 injections with 100, 1000 and finally 10000 SQ contained in each 0.1 mL |
| Dose escalation: high dose and volume | Active comparator | Drug: ALUTARD SQ® Felis domesticusPatients will get 3 injections 200, 2000 and finally 10000 SQ contained in 0.2, 0.2 and finally 0.1 mL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALUTARD SQ® Felis domesticusThe drug is approved for use in Switzerland for subcutaneous injections. I this study, we will test the intralympahtic injection | Drug | ALUTARD SQ® Felis domesticus, Dose escalation: low dose and volume, ALUTARD SQ® Felis domesticus, Fix dose: 1000 SQ, Dose escalation: high dose and volume |
Primary outcome
Change of blood tryptase levels at baseline, after first ILIT and in case of systemic allergic reactions
Time frame: From enrollment to the end of treatment at 8 monts. At Baseline, 2 hours after the first Injection and within 1 hour in case of systemic allergic reactions.
The overall objective is to test whether ILIT with a cat hair allergen extract is safe and tolerable in patients with allergy to cat hair allergen. To assess safety, blood tryptase levels (μg/L) are measured at baseline, 2 hours after the first ILIT and within 1 hour in case of systemic allergic reactions in the following ILIT-visits. Tryptase is released during a systemic allergic reaction.
Incidence and severity of adverse events using the WAO rating system 2024
Time frame: From enrollment to the end of treatment at 8 months.
Safety assessment by analyzing allergic reactions and their severity using World Allergy Organization Grading System (WAO 2024). The scale reaches from 0 (no averse events) to 5 (e.g. anaphylaxis or respiratory or cardiac arrest). Higher number indicating higher severity.
14 secondary outcomes
Effect on phenotype and reactivity of cat-allergen-specific lymphocytes measuring basophil activation to cat allergen
Time frame: From enrollment to the end of treatment at 8 months.
Change in total IgE concentration from baseline to each injection, 1 and 4 months after the end of treatment
Time frame: From enrollment to the end of treatment at 8 months.
Change in cat allergen-specific IgE from baseline to each injection and 1 and 4 months after the end of treatment
Time frame: From enrollment to the end of treatment at 8 months.
Change in cat allergen-specific IgG4 from baseline to each injection, 1 and 4 months after the end of treatment
Time frame: From enrollment to the end of treatment at 8 months
Change in cat allergen-specific IgG from baseline to each injection, 1 and 4 months after the end of treatment
Time frame: From enrollment to the end of treatment at ca. 8 months
Assessment of treatment benefit by calculating the ratio of cat allergen-specific IgG4 to IgE
Time frame: From enrollment to the end of treatment at 8 months.
Change in skin sensitivity by measuring the diameters in Skin Prick Test (SPT) at baseline and 4 months after treatment
Time frame: From enrollment to the end of treatment at 8 months. At baseline and at 4 months after end of treatment.
Change in spirometry from baseline and 4 months after end of treatment
Time frame: From enrollment to the end of treatment at 8 months. At baseline and 4 months after end of treatment.
Change of Fraction Exspiratory Nitric Oxide (FeNo) from baseline to 4 months after end of treatment
Time frame: From enrollment to the end of treatment at 8 months. At baseline and at 4 months after treatment.
Efficacy assessment using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: From enrollment to the end of treatment at 8 months
Efficacy assessment using Asthma Quality of Life Questionnaire (AQLQ)
Time frame: From enrollment to the end of treatment at 8 months
Change in leukotriene release of blood cells from baseline to each injection and 1 and 4 months after the end of treatment
Time frame: From enrollment to the end of treatment at 8 months. At baseline, each ILIT injection, 1 and 4 months after 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.
Time frame: From enrollment to the end of treatment at 8 months. 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
Time frame: From enrollment to the end of treatment at 8 months. At baseline and 4 months after end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- publishd work on intralymphatic allergen immunotherapyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Summary of data upon analysis will be shared upon termination of the study. Protocols may be shared during the study upon contact with P or sponsor. Study and data will be published upon termination of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALUTARD SQ® Felis domesticus in people with Allergic Rhinitis and Allergic Asthma, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pål Johansen, Professor, PhD (+41 44 255 8616, pal.johansen@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood tryptase levels at baseline, after first ILIT and in case of systemic allergic reactions (time frame: From enrollment to the end of treatment at 8 monts. At Baseline, 2 hours after the first Injection and within 1 hour in case of systemic allergic reactions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.