Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice (NCT07651891) | Clinical Trial Compass
RecruitingPhase 4
Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice
Sweden40 participantsStarted 2026-08-01
Plain-language summary
STUDY DESIGN A single-center prospective before-and-after study evaluating the effect of Alutard SQ Dog in 40 men and women with moderate-to-severe dog allergy. Participants will serve as their own controls.
STUDY OUTLINE
The study will begin in the fall of 2026 and will be conducted over a one-year period. At baseline, participants will be asked to record their allergic symptoms, and assessments of lung function and nasal airflow will be performed. Blood samples will also be collected.
Following the baseline assessments, participants will undergo allergen provocation by entering a facility containing dogs. After a 30-minute exposure to dogs, participants will again be asked to record their allergic symptoms and will undergo the same assessments performed at baseline.
Allergen immunotherapy (AIT) with Alutard SQ Dog will then be initiated according to the standard treatment regimen and continued for one year. At the end of the treatment period, the same provocation procedure and assessments will be repeated. Participants will enter a facility containing dogs, followed by symptom recording and evaluation of lung function, nasal airflow, and relevant laboratory parameters.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
The subject has provided written informed consent to participate in the study.
* Age 18-50 years.
* Moderate-to-severe allergic symptoms upon exposure to dogs.
* Dog allergy confirmed by positive specific IgE.
* Considered suitable by the investigator for treatment with Alutard SQ Dog in accordance with the approved Summary of Product Characteristics (SmPC).
* Female subjects of childbearing potential must use adequate contraception.
* A negative pregnancy test must be obtained prior to enrolment.
Exclusion Criteria
* Pregnancy or breastfeeding.
* Autoimmune or connective tissue disease.
* Cardiovascular disease.
* Hepatic disease.
* Renal disease.
* Malignancy.
* Upper airway disease (e.g., non-allergic sinusitis or nasal polyposis).
* Chronic obstructive or restrictive lung disease.
* Treatment with medications that may interfere with the immune response.
* Previous immunotherapy or chemotherapy.
* Significant chronic disease.
* Major metabolic disease.
* Alcohol or substance abuse.
* Mental or cognitive incapacity that may impair compliance with study procedures.
* Known or suspected hypersensitivity to the study product.
* Suspected or confirmed bacterial infection.
* Clinically relevant allergy to house dust mite.
* Current dog ownership.
* Any condition that, in the investigator's opinion, may make participation, follow-up, or study assessments inappropriate.
* Any subject considered unsuitable for enrolment according to the principles of the Decl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total nasal symptom score (TNSS)
Timeframe: Patients will be exposed to dog allergen at baseline and again after one year of treatment with Alutard SQ dog. TNSS will be assessed at both occasions.