Canis familiaris (553) for Allergic rhinitis due to dog allergy

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the trial.\n- Age between 18-50\n- Moderate to severe allergy symptoms when in contact with dogs.\n- Considered suitable by investigator to be prescribed Alutard SQ Dog in line with approved SPC.\n- For female subjects of fertile age, adequate contraception should be used. A negative pregnancy test should be collected prior to inclusion.\n- Allergy confirmed with positive specific IgE to dog."}

Exclusion criteria

• {"criterion_text":"- Pregnancy or nursing.\n- Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.\n- Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.\n- Autoimmune or collagen disease.\n- Cardiovascular disease.\n- Hepatic disease.\n- Renal disease.\n- Cancer.\n- Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive and restrictive lung disease).\n- Medication with a possible side-effect of interfering with the immune response.\n- Previous immuno- or chemotherapy.\n- Chronic disease.\n- Withdrawal of consent.\n- Discontinuation of the study treatment as defined in section 7.1.\n- Premature withdrawal by the Investigator/Sponsor due to safety or any other reason.\n- Lack of adherence to the study protocol and instructions given by the investigator.\n- Major metabolic disease.\n- Alcohol or drug abuse.\n- Mental incapability of coping with the study.\n- Known or suspected allergy to the study product.\n- Suspicion of or confirmed bacterial infection.\n- Mite allergy.\n- Dog owner."}

Primary endpoints

• {"endpoint_text":"- Improvement in Rhinoconjunctivitis Total Symptom Score (RTSS) and visual analogue scale (VAS) registered 30 min after provocation with dog dander before and after one year treatment with Alutard SQ Dog.","definition_or_measurement_approach":"RTSS and VAS measured 30 minutes after provocation with dog dander, compared before treatment and after one year of treatment with Alutard SQ Dog."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of AEs and SAEs.\n- Conjunctions between levels of total IgE and specific IgE (Can f 1, Can f 2, Can f 4, Can f 5, Can f 6) and the treatment effect of Alutard SQ dog.\n- Improvement of PNIF and PEF after contact with dogs before and after treatment with Alutard SQ Ddog.","definition_or_measurement_approach":"Occurrence of AEs and SAEs: safety events collected and recorded during study visits. IgE endpoints: measurement of total IgE and specific IgE (Can f 1, Can f 2, Can f 4, Can f 5, Can f 6) in peripheral blood and correlation with treatment effect. PNIF and PEF: objective measurements of peak nasal inspiratory flow (PNIF) and peak expiratory flow (PEF) after provocation with dog dander before and after treatment."}

Sweden

Earliest CTIS Part Ii Submission Date

12-12-2024

Latest Decision Or Authorization Date

14-01-2026

Processing Time Days

398

Number Of Sites

3

Number Of Participants

40

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden