Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Pregnancy or breastfeeding.
Autoimmune or connective tissue disease.
Cardiovascular disease.
Hepatic disease.
Trial design
Design model
Single group
Treatments tested in this trial
ALK Alutard SQ Dog
DrugThe study is based on Swedish guidelines with an up-titration period of 13 weeks from 100 SQ to 100.000 SQ. The maximum dose of 100.000 SQ is the given every 6-8 weeks for 3 years.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TreatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Total nasal symptom score (TNSS)
Sneezing: 0-3 points Nasal itching: 0-3 points Nasal congestion: 0-3 points Rhinorrhea (runny nose): 0-3 points
Time frame
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.Secondary outcomes
1
PEF
Peak expiratory flow - PEF
Time frame
Patients will be exposed to dog allergen at baseline and again after one year of treatment with Alutard SQ dog. Peak expiratory flow will be measuered at both occasions.2
PNIF
Peak nasal inspiratory flow
Time frame
Patients will be exposed to dog allergen at baseline and again after one year of treatment with Alutard SQ dog. PNIF will be measuered at both occasions.3
Bloodsample
specific levels of IgE (Can f 1, Can f 2, Can f 3, Can f 4, Can f 5, Can f 6)
Time frame
Bloodsample will be taken prior to treatment and after 1 year of treatmentSponsors and contacts
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Source ClinicalTrials.gov