Allergic rhinitis/rhinoconjunctivitis induced by house dust mite MedDRA version: 20.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870
Conditions
Interventions
Trade Name: ACARIZAX 12 SQ-HDM
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
Other descriptive name: DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
Concent
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent obtained from subjects’ legal representatives before any trial related procedures are performed • Male or female subjects aged =12 to =17 years on the screening day (visit 1) and at the FU-TC. • 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 screening visit (visit 1) • Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening (wheal size of =3 mm) • Lung function measured by Forced expiratory volume in 1 second (FEV1) = 70% of predicted value or according to local requirements while on subject's usual asthma medication Are the trial subjects under 18? yes Number of subjects for this age range: 250 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 subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA) • Any SLIT or SCIT (Subcutaneous allergy immunotherapy) treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1 • Ongoing treatment with any allergy immunotherapy product at screening • Severe chronic oral inflammation • A diagnosis or history of eosinophilic oesophagitis • Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration (visit 2) • Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial • Sexually active female of childbearing potential without medically accepted contraceptive method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate safety and tolerability of the HDM SLIT-tablet in adolescents (12-17 years of age) with 28 days of treatment ;Secondary Objective: There are no secondary objectives. ;Primary end point(s): At least one treatment-emergent adverse event (TEAE) ;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • At least one solicited TEAE • At least one IMP-related AE • At least one treatment-emergent serious adverse event (SAE) ;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Czech Republic, Germany, Slovakia
Contacts
Public ContactClinical Trials Information
ALK-Abelló A/S
Outcome results
None listed