Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
3
Allergic rhinitis due to dog allergy
The primary objective of this trial is to evaluate the effectiveness of Alutard SQ dog in dog allergic patients by evaluating improvement in allergic symptoms after one year treatment
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-01-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Karolinska Institutet, Stockholm, Sweden
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The primary objective of this trial is to evaluate the effectiveness of Alutard SQ dog in dog allergic patients by evaluating improvement in allergic symptoms after one year treatment
Secondary objectives 3
- Safety aspects of the treatment. Occurrence of AEs and SAEs.
- Molecular and immunological changes in peripheral blood samples.
- Improvement in asthma and nasal breathing after one year treatment with Alutard SQ Dog.
Conditions and MedDRA coding
Allergic rhinitis due to dog allergy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10039085 | Rhinitis allergic | 100000004855 |
| 27.0 | PT | 10063532 | Allergic respiratory disease | 100000004855 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- The subject has given their written consent to participate in the trial.
- Age between 18-50
- Moderate to severe allergy symptoms when in contact with dogs.
- 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.
- Allergy confirmed with positive specific IgE to dog.
Exclusion criteria 23
- Pregnancy or nursing.
- 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 enrollment.
- 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.
- Withdrawal of consent.
- Discontinuation of the study treatment as defined in section 7.1.
- Premature withdrawal by the Investigator/Sponsor due to safety or any other reason.
- Lack of adherence to the study protocol and instructions given by the investigator.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 3
- Occurrence of AEs and SAEs.
- 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.
- Improvement of PNIF and PEF after contact with dogs before and after treatment with Alutard SQ Ddog.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
ALUTARD SQ epitel, injektionsvätska, suspension - 553 Hund
PRD10277648 · Product
- Active substance
- Canis Familiaris (553)
- Substance synonyms
- 553 dog hair
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 100000 SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated)
- Max total dose
- 100000 SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- V01AA11 — ANIMALS
- Marketing authorisation
- 10368
- MA holder
- ALK-ABELLO A/S
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Livostin 0,5 mg/ml ögondroppar, suspension
PRD2020776 · Product
- Active substance
- Levocabastine Hydrochloride
- Pharmaceutical form
- EYE DROPS, SUSPENSION
- Route of administration
- INTRAOCULAR USE
- Max daily dose
- 0.5 mg/ml milligram(s)/millilitre
- Max total dose
- 0.5 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01GX02 — LEVOCABASTINE
- Marketing authorisation
- 11328
- MA holder
- MCNEIL SWEDEN AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Nasonex 50 mikrogram/dos nässpray, suspension
PRD9241349 · Product
- Active substance
- Mometasone Furoate
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 400 µg microgram(s)
- Max total dose
- 400 µg microgram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R01AD09 — MOMETASONE
- Marketing authorisation
- 13216
- MA holder
- N.V. ORGANON
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Desloratadine Sandoz 5 mg filmdragerade tabletter
PRD922839 · Product
- Active substance
- Desloratadine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R06AX27 — DESLORATADINE
- Marketing authorisation
- 45779
- MA holder
- SANDOZ A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Nobels Vag 6
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Lars Olaf Cardell
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Lars Olaf Cardell
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 40 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Region Skane Lasarettet Trelleborg
Ear, Nose and Throat Clinic, Hedvagen 46, 231 52, Trelleborg
Karolinska University Hospital
Ear and hearing center, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Oto-Rhino-Laryngology, Research Unit, Entregatan 7, 222 42, Lund
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CRF | 2.0 |
| Protocol (for publication) | Patient facing document_Questionnaires | 1.0 |
| Protocol (for publication) | Protocol 2024-517649-15-00 | 2.0 |
| Protocol (for publication) | SoC_Protocol | 1.0 |
| Recruitment arrangements (for publication) | Annons | 1 |
| Recruitment arrangements (for publication) | Forfarande for rekrytering och samtyckesprocess | 1 |
| Subject information and informed consent form (for publication) | SIS and ICF | 2 |
| Subject information and informed consent form (for publication) | SIS and ICF | 4.1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Alutard SQ Hundhar sv | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis SE 2024-517649-15-00 | 2.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-03 | Sweden | Acceptable 2025-01-13
|
2025-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-29 | Sweden | Acceptable 2025-01-13
|
2025-01-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-29 | Sweden | Acceptable 2025-01-13
|
2025-01-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-09 | Sweden | Acceptable 2025-01-13
|
2025-04-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-18 | Sweden | Acceptable 2026-01-12
|
2026-01-14 |