Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice (ALLERDOG)

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis; Asthma (Diagnosis)
• Intervention / Treatment: Drug: ALK Alutard SQ Dog

Detailed Description

• Lung function assessed by Peak Expiratory Flow (PEF)
• Nasal airflow assessed by Peak Nasal Inspiratory Flow (PNIF)
• Serum levels of allergen-specific IgE to Can f 1, Can f 2, Can f 3, Can f 4, Can f 5, and Can f 6
• Symptom severity assessed using a Visual Analogue Scale (VAS)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carl Skröder, MD; Phone Number: +46 41055181; Email: carl.skroder@ki.com
• Study Contact Backup: Name: Lars Olaf Cardell, Professor; Email: lars-olaf.cardell@ki.se

Study Locations

• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 23152
      • Recruiting
      • Lund University Hospital
      • Contact: Lars Olaf Cardell, Professor; Email: lars-olaf.cardell@ki.se
      • Contact: Franziska Nordström, MD; Phone Number: +46704447341; Email: franziska.nordstrom@skane.se
    • Trelleborg, Skåne County, Sweden, 23152
      • Recruiting
      • Trelleborg Hospital
      • Contact: Lars Olaf Cardell, Professor; Email: lars-olaf.cardell@ki.se
      • Contact: Carl Skröder, MD; Phone Number: +46 41055181; Email: carl.skroder@ki.se
      • Sub-Investigator: Carl Skröder, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Declaration of Helsinki.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; All patients will receive the same treatment and serve as their own controls.	Drug: ALK Alutard SQ Dog; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bloodsample	specific levels of IgE (Can f 1, Can f 2, Can f 3, Can f 4, Can f 5, Can f 6)	Bloodsample will be taken prior to treatment and after 1 year of treatment
PEF	Peak expiratory flow - PEF	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.
PNIF	Peak nasal inspiratory flow	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.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Lars Olaf Cardell, Karolinska Institutet, Division of ENT

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Allergic rhinitis; SCIT; AIT
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Pathological Conditions, Signs and Symptoms; Asthma; Disease; Rhinitis, Allergic
• Other Study ID Numbers: CS793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pseudonymized aggregate data will be published. Pseudonymized individual participant data will be made available upon reasonable request.
• IPD Sharing Time Frame: Raw study data will be retained for 10 years following study completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to pseudonymized individual participant data for the purpose of verifying the study results. Data will be provided upon reasonable request after publication of the study results and will be shared electronically by email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No