allergic rhinitis MedDRA version: 14.0 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10001724 Term: Allergic rhinitis (excl hay fever) System Organ Class: 10038738 - Respirat
Conditions
Interventions
Product Name: ALK house dust mite (HDM) allergy immunotherapy tablet (AIT)
Product Code: ALK HDM AIT
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: N/A
Current Sponsor code: ALK HDM AIT
O
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Written informed consent obtained before entering the trial. I2. Subject 18-65 years of age, with a clinical history consistent with moderate to severe persistent HDM allergic rhinitis (with or without asthma) for at least one year prior to trial entry, with allergic rhinitis symptoms despite having received symptomatic treatment. I3. Moderate to severe HDM allergic rhinitis symptoms during the baseline period defined as a daily total rhinitis symptom score of at least 6, or a score of at least 5 with one symptom being severe, during at least 8 days of the 15-days baseline period. I4. Use of symptomatic medication for treatment of HDM allergic rhinitis during at least 8 days of the 15-days baseline period. I5. Presence of one or more of the following ARIA quality of life items due to HDM allergic rhinitis during the baseline period: 1) Sleep disturbance 2) Impairment of daily activities, leisure and/or sport 3) Impairment of school or work I6. If asthma, daily use of ICS should be =400mcg budesonide or equivalent3 (i.e. corresponding to GINA treatment steps 1 or 2). I7. Positive skin prick test response (wheal diameter =3 mm) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. I8. Positive specific IgE against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae (defined as =IgE Class 2; or =0.70 kU/L). I9. Male, Female (infertile), Female, with a negative pregnancy test and willingness to practise appropriate6 contraceptive methods until treatment with IMP has been discontinued. I10. Subject willing and able to comply with 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 900 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: E1. A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis and/or asthma caused by an allergen to which the subject regularly exposed and overlapping with the 8-week efficacy assessment period. E2. A clinically relevant history of symptomatic allergic rhinoconjunctivitis caused by mould or by animal hair and dander to which the subject is regularly exposed. E3. Reduced lung function (defined as FEV1<70% of predicted value after adequate pharmacologic treatment). E4. A clinical history of uncontrolled asthma7 within 3 months prior to screening. E5. Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation. E6. Any nasal condition that could confound the efficacy or safety assessments (e.g. nasal polyposis). E7. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation. E8. Previous treatment with immunotherapy with HDM allergen or a cross-reacting allergen for more than 1 month within the last 5 years. Initiation of subcutaneous immunotherapy is acceptable, if treatment has been discontinued before reaching maintenance dose. E9. Ongoing treatment with any specific immunotherapy. E10. History of anaphylaxis with cardio-respiratory symptoms (food allergy, drugs or an idiopathic reaction). E11. History of 2 or more episodes of generalised urticaria during the last 2 years. E12. History of drug induced (incl. immunotherapy) facial angioedema or a familiy (parents and siblings) history of hereditary angioedema. E13. Any clinically relevant chronic disease (=3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency). E14. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease). E15. Severe inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, immune deficiency diseases or multiple sclerosis). E16. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit (except steroids for allergic rhinitis and asthma). E17. Current treatment with ACE inhibitors, tricyclic antidepressants; catechol-O-methyl transferase inhibitors (COMT inhibitors) and mono amine oxidase inhibitors (MAOIs). E18. Use of medication listed in the table of "Prohibited Concomitant Medication" (Table 2) within the specified timeframes. E19. Use of any IMP within 30 days/5 half-lives of the product (which ever longest) prior to randomisation. E20. History of allergy, hypersensitivity or intolerance to the excipients of the IMP or to the symptomatic medications. E21. History of alcohol or drug abuse within the past 2 years. E22. Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ALK HDM AIT given once daily compared to placebo in the treatment of HDM allergic rhinitis. The primary endpoint is the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment. The TCRS is the sum of the allergic rhinitis daily symptom score (DSS) and the allergic rhinitis daily medication score (DMS) averaged over the last 8 weeks of treatment.;Secondary Objective: To determine the effect of the ALK HDM AIT on average allergic rhinitis DSS, average allergic rhinitis DMS and average total combined rhinoconjunctivitis score. Additional secondary objectives of the trial are: To evaluate the safety and tolerability of ALK HDM AIT treatment To determine the effect of the ALK HDM AIT on individual rhinitis and conjunctivitis symptoms, medication use, onset of action, treatment satisfaction, and generic and disease-specific quality of life. Immunological parameters will be investigated for a subset of the subjects.;Primary end point(s): The average total combined rhinitis score (TCRS) during the last 8 weeks of the 12 months period of treatment. The TCRS is the sum of the total allergic rhinitis daily symptom score (DSS) and the allergic rhinitis daily medication score (DMS) averaged over the last 8 weeks of the 12 months period of treatment.;Timepoint(s) of evaluation of this end point: Measured over the last 8 weeks of the 12 months period of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The average total allergic rhinitis DSS during the last 8 weeks of 12 months treatment. The average total allergic rhinitis DMS during the last 8 weeks of 12 months treatment. The average total combined allergic rhinoconjunctivitis score during the last 8 weeks of 12 months treatment Other efficacy endpoints include: The average total allergic rhinoconjunctivitis DSS during the last 8 weeks of 12 months treatment. The average total allergic rhinoconjunctivitis DMS during the last 8 weeks of 12 months treatment. The average total allergic conjunctivitis DSS, allergic conjunctivitis DMS and combined conjunctivitis score during the last 8 weeks of 12 months treatment. Onset of efficacy, based on DSS and DMS during all one week diary periods. The average individual allergic DSS during the last 8 weeks of 12 months treatment RQLQ. Global evaluation for efficacy. Immunology markers. Symptom free days. EQ-5D. TSQM II. WPAI-AS. Health care utilisation based on GP/specialist visits The safety endpoints for the trial include Local AEs including oral pruritus, ear pruritus, throat irritation and mouth oedema. AEs, SAEs, AE withdrawals, clinical laboratory tests, vital signs, physical examination;Timepoint(s) of evaluation of this end point: Measured over the last 8 weeks of the 12 months period of treatment | — |
Countries
Austria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Germany, Latvia, Serbia, Ukraine
Contacts
Public ContactMedical expert
ALK-Abelló A/S
Outcome results
None listed