Allergic RhinitisPhase 4ALLERDOGNCT07651891
Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice
A Phase 4 study testing ALK Alutard SQ Dog in people with Allergic Rhinitis and Asthma (Diagnosis), run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis, Asthma (Diagnosis)
- What is being tested?
- ALK Alutard SQ Dog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or breastfeeding.
- Autoimmune or connective tissue disease.
- Cardiovascular disease.
- Hepatic disease.
- Renal disease.
- Malignancy.
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lars Olaf Cardell, Professor contact
Sweden2 sites, 2 recruiting
- Recruiting
Lund University Hospital
Lund, Skåne County, 23152
Franziska Nordström, MD, +46704447341, franziska.nordstrom@skane.se
Lars Olaf Cardell, Professor, lars-olaf.cardell@ki.se
- Recruiting
Trelleborg Hospital
Trelleborg, Skåne County, 23152
Carl Skröder, MD, +46 41055181, carl.skroder@ki.se
Lars Olaf Cardell, Professor, lars-olaf.cardell@ki.se
About this study
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
Read more
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.
Read the 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)
- Conditions
- Allergic Rhinitis, Asthma (Diagnosis)
- Being tested
- ALK Alutard SQ Dog
- Keywords
- AIT, SCIT, Allergic rhinitis, Asthma
- Medical subject headings
- Rhinitis, Allergic, Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK Alutard SQ DogDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | All patients will receive the same treatment and serve as their own controls. Receives: Drug: ALK Alutard SQ Dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (3)
PEF
Peak expiratory flow - PEF
Measured: 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
Measured: 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.
Bloodsample
specific levels of IgE (Can f 1, Can f 2, Can f 3, Can f 4, Can f 5, Can f 6)
Measured: Bloodsample will be taken prior to treatment and after 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm interventional study in which participants serve as their own controls.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Olaf Cardell, Karolinska Institutet
- Investigators
- Lars Olaf Cardell, Principal investigator, Karolinska Institutet, Division of ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651891
- Sponsor's protocol ID
- CS793
- Acronym
- ALLERDOG
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized aggregate data will be published. Pseudonymized individual participant data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice
- ClinicalTrials.gov ID
- NCT07651891
- Acronym / sponsor ID
- ALLERDOG / CS793
- Conditions
- Allergic Rhinitis, Asthma (Diagnosis)
- Keywords
- AIT, SCIT, Allergic rhinitis, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm interventional study in which participants serve as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Drug: ALK Alutard SQ DogAll patients will receive the same treatment and serve as their own controls. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (20 listed)
- Pregnancy or breastfeeding.
- Autoimmune or connective tissue disease.
- Cardiovascular disease.
- Hepatic disease.
- Renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALK Alutard SQ DogThe 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. | Drug | Treatment |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: 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.
Sneezing: 0-3 points Nasal itching: 0-3 points Nasal congestion: 0-3 points Rhinorrhea (runny nose): 0-3 points
3 secondary outcomes
PEF
Time frame: 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
Time frame: 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.
Bloodsample
Time frame: Bloodsample will be taken prior to treatment and after 1 year of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Pseudonymized aggregate data will be published. Pseudonymized individual participant data will be made available upon reasonable request.
Related trials for Allergic Rhinitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Olaf Cardell, Professor contact
Lars Olaf Cardell principal investigator
Karolinska Institutet, Division of ENT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ALK Alutard SQ Dog in people with Allergic Rhinitis and Asthma (Diagnosis), run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Skröder, MD (+46 41055181, carl.skroder@ki.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total nasal symptom score (TNSS) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.