A clinical trial studying the safety of the house dust mite tablets in adolescents with allergic rhinitis/rhinoconjunctivitis
- Conditions
- Allergic rhinitis/rhinoconjunctivitis induced by house dust miteMedDRA version: 20.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-000446-34-DE
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
• 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 moderate to severe allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM (diagnosed by a physician) of 1-year duration or more (with or without asthma) and with allergic rhinitis (AR) 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): • At least one solicited TEAE <br>• At least one IMP-related AE <br>• At least one treatment-emergent serious adverse event (SAE) ;Timepoint(s) of evaluation of this end point: At the end of the study.