House Dust Mite Allergy
Conditions
Brief summary
hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.
Interventions
BIOLOGICALPlacebo solution
15 injections over 7 weeks
BIOLOGICALhdmASIT+TM
15 injections over 7 weeks
Sponsors
ASIT Biotech S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001)) * A positive skin prick test to house dust mite Dermatophagoides pteronyssinus * Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L * Positive response to Conjunctival Provocation Test (CPT) * Being treated with anti-allergic medication for at least 12 months prior to enrollment * For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value
Exclusion criteria
* Previous immunotherapy with house dust mite allergens within the last 5 years * Ongoing immunotherapy with house dust mite allergens or any other allergens * History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc. * Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014) * Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) \< 80% of the patient's reference value (ECSC) * History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited adverse events | up to 7 weeks | * Local reactions at the injection site * Allergic systemic reactions |
Secondary
| Measure | Time frame |
|---|---|
| Unsolicited adverse events and serious adverse events (SAEs) | up to 12 weeks |
| Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure) | up to 12 weeks |
| Laboratory investigations (haematology, clinical biochemistry, immunological parameters) | up to 12 weeks |
| Pulmonary functions (FEV1) for asthmatic patients | up to 7 weeks |
Countries
Germany
Outcome results
None listed