Allergic rhinitis/rhinoconjunctivitis induced by house dust mites MedDRA version: 20.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870
Conditions
Interventions
Trade Name: ACARIZAX
Product Name: HDM SLIT-tablet
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
Other descriptive name: DERMATOPHAGOIDES PTERONYSS
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, aged 5-11 years old at randomisation, of any race/ethnicity and weighing 15 kg or more on the day of screening - A clinical history of AR/C when exposed to HDM (diagnosed by a physician) of 1 year duration or more (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to the screening visit - Have a rhinitis DSS of at least 6, or a score of at least 5 with one symptom being severe, on at least 8 of the last 14 days of the baseline period - Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period - Presence of one or more of the Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to HDM AR/C during the last 14 days of the baseline period - Positive skin prick test (SPT) to D. pteronyssinus or D. farinae at screening - Positive D. pteronyssinus or D. farinae specific IgE (defined as =class 3, =3.5 kU/l) at screening - Lung function measured by FEV1 = 70% of predicted value or according to local requirements while on subject's usual asthma medication following at least a 6-hour washout of SABA at screening, baseline visit, and at randomisation Are the trial subjects under 18? yes Number of subjects for this age range: 1370 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -A clinically relevant history of symptomatic perennial AR/C caused by a perennial allergen source such as animal hair and dander and/or mould, or symptomatic seasonal AR/C and/or asthma caused by an allergen to which the subject is exposed in the baseline and/or efficacy assessment period. - SLIT or SCIT treatment reaching the maintenance dose, with D. pteronyssinus or D. farinae for more than 1 month within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months - Treatment with medications with potential impact on efficacy endpoints (e.g. treatment with anti-IgE drugs within 130 days/5 halflives of the drug (which ever longest) or treatment with antidepressant or antipsychotic medications with antihistaminergic effect) - Asthma requiring daily use of more than 400 mcg budesonide or equivalent at screening or any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation - A history of chronic urticaria (> 6 weeks) and/or chronic angioedema (> 6 weeks) within the last 2 years prior to screening that in the opinion of the investigator may constitute an increased safety concern. - A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern - Severe chronic oral inflammation - A diagnosis or history of eosinophilic oesophagitis - Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance or any immunosuppressive treatment within 3 months prior to screening - Known history of allergy, hypersensitivity or intolerance to any of the excipients or active substances of the IMP (except for D. pteronyssinus and/or D. farinae) or to any excipient of the rescue medication provided in this trial - May be at greater risk of developing severe adverse reactions after adrenaline/epinephrine administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet compared to placebo in the treatment of HDM allergic rhinitis (AR) in children (5-11 years of age) based on total combined rhinitis symptoms and medication use (TCRS) during the primary efficacy assessment period.;Secondary Objective: The key secondary objectives are to demonstrate the efficacy of the HDM SLIT-tablet compared to placebo during the primary efficacy assessment period based on: 1. Rhinitis symptoms (based on DSS) 2. Rhinitis medication use (based on DMS) 3. Combined rhinoconjunctivitis symptoms and medication use (based on TCS) The additional secondary objectives are to evaluate the HDM SLIT-tablet compared to placebo during the primary efficacy assessment period with respect to: - Safety and tolerability - Rhinoconjunctivitis symptoms - Rhinoconjunctivitis medication use - Rhinoconjunctivitis quality of life (QoL) - Asthma symptoms and medication use -Changes in immunological parameters;Primary end point(s): Primary efficacy endpoint during the efficacy assessment period is: The average daily TCRS The daily TCRS is the sum of the rhinitis daily symptoms score (DSS) and the rhinitis daily medication score (DMS).;Timepoint(s) of evaluation of this end point: During the efficacy assessment period which is the last 8 weeks (period 4) of the approximately 12 months IMP treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoints during the efficacy assessment period are: - The average rhinitis DSS - The average rhinitis DMS - The average total combined score (TCS) The daily TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS + conjunctivitis DSS) and the rhinoconjunctivitis DMS (rhinitis DMS + conjunctivitis DMS). The safety and tolerability endpoints are: - Treatment-emergent adverse events (TEAEs), solicited AEs, IMP related AEs, treatment-emergent serious adverse events (SAEs), event of special interest (ESI), TEAEs leading to discontinuation, time to discontinuation due to TEAEs - Vital signs, physical examination, FEV1 and clinical laboratory values during treatment and at the final visit (visit 7) Additional secondary efficacy endpoints during the efficacy assessment period are: - Average rhinoconjunctivitis DSS - Average rhinoconjunctivitis DMS - Paediatric rhinoconjunctivitis quality of life questionnaire (PRQLQ) - Average asthma DSS - Average daily use of short-acting ß2-agonist (SABA) - Rhinitis mild days - Rhinitis exacerbation days (days with a rhinitis DSS of 6 or of 5 with one individual symptom scored 3 (symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping)) - Average rhinitis combined symptom and medication score (CSMS) The immunologic endpoints are: - Change from baseline in specific IgE and IgG4 to D. pteronyssinus and D. farina, change in baseline for HDM IgE-Blocking factor (IgE-BF) and change in baseline for total IgE measured at end of trial (visit 7);Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated during the efficacy asessment period, as specified for applicable endpoints, or througout the trial (safety and tolerability as well as immunologic endpoints). | — |
Countries
Bulgaria, Canada, France, Germany, Lithuania, Poland, Russian Federation, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactClinical Trials Information
ALK Global Clinical Development
Outcome results
None listed