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

STUDY DESIGN A single center case-control study evaluating the effect of Alutard SQ dog among 40 healthy men and women with moderate- to severe dog allergic patients. Recruited patients will be their own controls.

STUDY OUTLINE The study will begin during the fall 2026. The trial will run over a one-year period. Patients will be asked to register allergic symptoms (base line), lungfunction and nasal breathing will be tested. Bloodsamples will be taken. Shortly after they will be provoked by entering a facility containing dogs. After 30 min provocation (contact with dog) they will again be asked to register allergic symptoms and undergo the same tests as before the treatment start. Allergic immunotherapy (allergy vaccination) with Alutard SQ dog is initiated according to a standard treatment plan and continued for one year. After one year the same procedure will be performed. Provocation will be performed by entering a facility containing dogs, followed by symptom registration and testing.

Study Overview

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

Detailed Description

Measurement of lungfunction with PEF (Peak expiratory flow) Measurement of nasal breathing with PNIF (Peak nasal inspiratory flow) Blodsample - specific levels of IgE (Can f 1, Can f 2, Can f 3, Can f 4, Can f 5, Can f 6) VAS - visual analog scale

• 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 given their written consent to participate in the trial.

- Age between 18-50.

- Moderate to severe allergic symptoms when in contact with dogs.

- Allergy confirmed with positive specific IgE to dog.

- Considered suitable by investigator to be prescribed Alutard SQ Dog in line with approved SPC.

- For female subjects of fertile age, adequate contraception should be used. A negative pregnancy test should be collected prior to inclusion.

Exclusion Criteria:

-

- Pregnancy or nursing.

- Autoimmune or collagen disease.

- Cardiovascular disease.

- Hepatic disease.

- Renal disease.

- Cancer.

- Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive and restrictive lung disease).

- Medication with a possible side-effect of interfering with the immune response.

- Previous immuno- or chemotherapy.

- Chronic disease.

- Major metabolic disease.

- Alcohol or drug abuse.

- Mental incapability of coping with the study.

- Known or suspected allergy to the study product.

- Suspicion of or confirmed bacterial infection.

- Mite allergy

- Dog owner

- Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.

- Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.

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
Active Comparator: Treatment; All patients will recieve the same treatment and they are 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 Itchy nose 0-3 points Blockage 0-3 points Runny nose 0-3 points	TNSS will be registered after provocation with dog dander prior to treatment and again 1 year after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEF	Peak expiratory flow - PEF	Peak expiratory flow will be measuered after provokation and prior to treatment and agian after 1 year of treatment.
PNIF	Peak nasal inspiratory flow	PNIF will be measuered after provokation and prior to treatment and agian after 1 year of treatment.
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

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 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: AIT, SCIT, allergic rhinitis, asthma
• 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: Pseudonomized group data will be published. Pseudonomized raw data will be shared on request.
• IPD Sharing Time Frame: After publication. Raw data will be saved for 10 years
• IPD Sharing Access Criteria: Scientist may retrieve data to verify the results of the study. Will be sent by mail on request
• 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