Allergic rhinitis induced by house dust mites (HDM) MedDRA version: 15.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: SLIToneULTRA HDM Mix 50 SRUs
Pharmaceutical Form: Oral solution in single-dose container
INN or Proposed INN: DERMATOPHAGOIDES PTERONYSSINUS
Other descriptive name: DERMATOPHAGOIDES PTER
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written Informed consent before entering the trial 2. Male or female, aged 18 or older 3. A documented clinical relevant history of moderate to severe persistent HDM allergic rhinitis with or without asthma of at least one year prior to trial entry, with allergic rhinitis symptoms despite having received symptomatic medication 4. Moderate to severe HDM allergic rhinitis symptoms during the baseline period defined as a daily rhinitis symptom score of at least 6, or a score of 5 with one symptom being severe on the worst day in the 7-days baseline period 5. Positive skin prick test response (wheal diameter >= 3 mm) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. 6. Positive specific IgE against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae (>= IgE Class 2, >= 0.70 kU/l). 7. Subject is one of the following: Male or Female, infertile or Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with IMP has been discontinued. 8. Subject willing and able to comply with the trial protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment with immunotherapy with Dermatophagoides pteronyssinus and/or Dermatophagoides farinae or a cross-reacting allergen within the last 5 years 2. Ongoing treatment with any allergen specific immunotherapy product 3. Reduced lung function (defined as FEV1 3 months duration) (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality or any other diseases that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject) 6. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLIToneULTRA house dust mite (HDM) mix in adult subjects with moderate to severe HDM allergic rhinitis.;Secondary Objective: To evaluate the tolerability of SLIToneULTRA HDM mix. The evaluation is based on the number of adverse events observed in the trial.;Primary end point(s): Pre-to-post treatment change in specific IgE-blocking factor to Dermatophagoides pteronysinus;Timepoint(s) of evaluation of this end point: After 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pre-to-post treatment change in specific IgE-blocking factor to Dermatophagoides farinae Pre-to-post treatment change in IgG4 to Dermatophagoides pteronysinus and Dermatophagoides farinae Pre-to-post treatment change in specific IgE to Dermatophagoides pteronysinus and Dermatophagoides farinae Adverse Events and Serious Adverse Events;Timepoint(s) of evaluation of this end point: After 6 months of treatment | — |
Countries
Spain
Contacts
Public ContactMikkel Walmar
ALK-Abelló A/S
Outcome results
None listed