Patients, 18-60 years of age, suffering from house dust mites-induced persistent allergic rhinitis/rhinoconjunctivitis with or without concomitant at least partly controlled asthma. MedDRA version: 18.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: SUBLIVAC FIX Mite Mixture 10.000 AU/mL
Product Code: SUBLIVAC FIX Mite Mixture
Pharmaceutical Form: Oromucosal drops
INN or Proposed INN: House Dust Mites allergen extract
Current Spons
Sponsors
HAL Allergy B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent 2. Male or female patients, age=18= 60 years 3. Patients with allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, with or without concomitant at least partly controlled asthma 4. Patients with a history of concomitant asthma should have a FEV1 > 70% (of predicted value) at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80% (of predicted value) 5. Positive SPT to HDM D. pter or D. far (mean wheal diameter = 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter= 3 mm) at screening 6. Allergen specific serum IgE (ssIgE) level in serum for HDM D. pter or D. far (> 0.7 U/ml), assessed at screening 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter = 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter = 3 mm) who are expected to have clinically relevant symptoms during the treatment period 2. Patients sensitized and symptomatic to pets who are regularly exposed to pets 3. Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years 4. Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years 5. Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period 6. Any other vaccination one week before start of treatment and during the up-dosing phase 7. Any anti-IgE therapy within the last 6 months prior to inclusion and during study 8. Active inflammatory disease in the mouth (e.g periodontitis, oral mucosal lichen planus) 9. Known hypersensitivity to any of the excipients (i.e. Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, Aminocaproic acid, Glycerol, Peppermint oil, Caramel Colorant) of SLIT solution 10. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs 11. Active malignancies or any malignant disease in the last 5 years 12. A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders 13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma) 14. Use of systemic corticosteroids 4 weeks before start treatment 15. Treatment with systemic or local b-blockers 16. Clinically significant chronic sinusitis or ocular infection 17. Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study 18. Pregnancy, lactation or inadequate contraceptive measures (acceptable forms of birth control include Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections) or condom combined with a diaphragm including spermicidal cream. Also acceptable for women is surgical sterilization (removal of the uterus or ovaries or tubal ligation (”tied tubes”)), if they are postmenopausal (12 consecutive months without a period) for at least 2 years or having no sexual relationship with a man. 19. Alcohol, drug, or medication abuse within the past year and during the study 20. Any lack of co-operation or compliance 21. Severe psychiatric, psychological, or neurological disorders 22. Patients who are employees of the department or study site; 1st grade relatives, or partners of the investigator, or patients who are dependent on the sponsor 23. Any physical or mental condition that precludes administration of allergen-specific immunotherapy, compliance or participation in a trial 24. Patients who are placed in an institution due to governmental or judicial directive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the tolerability and safety by local and systemic reactions of different SUBLIVAC FIX Mite mixture dosages during 1 month of treatment in patients with HDM induced allergic rhinitis/rhinoconjunctivitis in comparison with placebo;Secondary Objective: •Safety determined by reported adverse events during 1 month of SUBLIVAC FIX Mite mixture treatment compared to placebo. • Safety determined by clinical and laboratory parameters assessed after 1 month of SUBLIVAC FIX Mite mixture treatment compared to placebo. • Immunogenic activity determined by changes in serum specific immunoglobulin levels (IgE, IgG, IgG4) compared to screening assessed after 1 month of SUBLIVAC FIX Mite mixture treatment compared to placebo. • Determine the proportion of patients in the different treatment groups reaching maintenance dose within 10 days;Primary end point(s): Safety and tolerability of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of local and systemic reactions.;Timepoint(s) of evaluation of this end point: After 1month of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of AEs • Safety of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by clinical and laboratory parameters • Changes in serum specific immunoglobulin levels (IgE, IgG, IgG4) after 1 month of treatment with different dosages of SUBLIVAC FIX Mite mixture compared to placebo • Proportions of patients in the different treatment groups reaching maintenance dose within 10 days;Timepoint(s) of evaluation of this end point: After 1 month of treatment. | — |
Countries
Germany
Contacts
Public ContactMedical Director
HAL Allergy B.V.
Outcome results
None listed