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Tests treatment safety and results for Allergic Rhinitis
Official title Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
ClinicalTrials.gov ID: NCT06960382
What this study is testing
What is ALUTARD SQ® Felis domesticus?
ALUTARD SQ® Felis domesticus is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for allergic rhinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.