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

Qualifiers

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

Treatments tested in this trial

  • ALK Alutard SQ Dog

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators