Evaluation of Alutard SQ Dog in Dog-Allergic Patients with Allergic Rhinitis: A Study on Efficacy and Symptom Improvement in Swedish Clinical Practice

The primary objective of this clinical trial is to evaluate the **effectiveness** of Alutard SQ dog in patients with **allergic rhinitis due to dog allergy** by assessing the improvement in allergic symptoms after one year of treatment. This is clinically relevant as it aims to provide evidence on the efficacy of allergen-specific immunotherapy in reducing symptoms associated with dog allergies, potentially improving the quality of life for affected individuals.

Secondary objectives include:

• Assessing the safety aspects of the treatment by monitoring the occurrence of adverse events (AE) and serious adverse events (SAE).
• Investigating molecular and immunological changes in peripheral blood samples.
• Evaluating the improvement in asthma and nasal breathing after one year of treatment with Alutard SQ dog.

The clinical trial focuses on individuals diagnosed with **allergic rhinitis due to dog allergy**. The study population includes both male and female participants, aged between 18 and 50 years, who experience moderate to severe allergy symptoms upon exposure to dogs. Participants are required to be in general good health, as determined by the investigator, and suitable for treatment with Alutard SQ Dog according to the approved Summary of Product Characteristics (SPC). Female participants of childbearing potential must use adequate contraception and provide a negative pregnancy test prior to inclusion. The sponsor has not provided information regarding the total number of participants. The trial does not involve a vulnerable population, and lifestyle factors such as diet and physical activity are not specified as part of the selection criteria.

The clinical trial is designed to evaluate the effectiveness of **Alutard SQ dog** in patients with **allergic rhinitis due to dog allergy**. This is a randomized, double-blind, controlled trial with a primary objective to assess the improvement in allergic symptoms after one year of treatment. The trial will involve a series of study visits, beginning with an inclusion visit where participants will be screened based on specific criteria, including age between 18-50, moderate to severe allergy symptoms upon contact with dogs, and suitability for the prescribed treatment. Female participants of fertile age must use adequate contraception and provide a negative pregnancy test prior to inclusion.

The trial will span approximately 18 months, with the estimated recruitment start date on January 1, 2025, and an estimated end date of June 30, 2026. Participants will be involved for a maximum treatment period of 12 months. The study visits will include regular follow-up assessments to monitor the primary endpoint, which is the improvement in total nasal symptom score (TNSS) and visual analog scale (VAS) after provocation with dog dander. Secondary endpoints will evaluate safety through the incidence and severity of adverse events, as well as the correlation between specific IgE levels and treatment effects.

Participants will be required to attend multiple follow-up visits throughout the trial to ensure accurate monitoring of their response to the treatment and to assess any adverse events. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the overall effectiveness and safety of the treatment. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or any adverse events that compromise participant safety.

The clinical trial involves the use of **ALUTARD SQ epitel**, a suspension for injection, containing the active substance **canis familiaris (553)**. This experimental medication is administered via **subcutaneous injection**. The dosage is standardized at 100,000 SQU/ml, with a maximum daily and total dose of 100,000 SQU/ml. The treatment period is set for a maximum of 12 months. This product is not a pediatric formulation and is manufactured by ALK-ABELLO A/S. The primary objective of the trial is to evaluate the effectiveness of ALUTARD SQ in improving allergic symptoms in dog-allergic patients over one year of treatment.

**Nasonex**, a nasal spray suspension, is used as a non-experimental treatment in the study. It contains the active substance **mometasone furoate** and is administered via nasal spray. The maximum daily and total dose is 400 micrograms, with a treatment period of up to 12 months. This product is not a pediatric formulation and is manufactured by N.V. ORGANON. It serves as an auxiliary treatment in the trial.

**Livostin**, an eye drops suspension, contains the active substance **levocabastine hydrochloride**. It is administered for intraocular use. The maximum daily and total dose is 0.5 mg/ml, with a treatment period of up to 12 months. This product is not a pediatric formulation and is manufactured by MCNEIL SWEDEN AB. It is used as an auxiliary treatment in the trial.

**Desloratadine Sandoz**, a film-coated tablet, contains the active substance **desloratadine**. It is administered orally. The maximum daily and total dose is 5 mg, with a treatment period of up to 12 months. This product is not a pediatric formulation and is manufactured by SANDOZ A/S. It is used as an auxiliary treatment in the trial.

The efficacy of the clinical trial titled "Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice - ALLERDOG SWEDEN" will be assessed primarily through the improvement in allergic symptoms in patients treated with Alutard SQ dog. The primary endpoint for efficacy evaluation is the improvement in the total nasal symptom score (TNSS) and visual analog scale (VAS) registered 30 minutes after provocation with dog dander, both before and after one year of treatment. These assessments will provide quantitative measures of symptom improvement, which are critical for determining the treatment's effectiveness.

Secondary endpoints include the evaluation of safety through the incidence and severity of adverse events during the study period. Additionally, the trial will assess the relationship between specific levels of **IgE** (Can f 1, Can f 2, Can f 4, Can f 5, Can f 6) and the treatment effect of Alutard SQ dog. Improvement in asthma and nasal breathing will also be evaluated after one year of treatment, with peak expiratory flow (PEF) and peak nasal inspiratory flow (PNIF) measured shortly after provocation. These endpoints will be measured using validated scales and laboratory tests at specified timepoints to ensure accurate and reliable data collection and analysis.