E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinitis/rhinoconjunctivitis induced by house dust mite |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020419 |
E.1.2 | Term | House dust mite allergy |
E.1.2 | System Organ Class | 100000004870 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
There are no secondary objectives. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
At least one treatment-emergent adverse event (TEAE) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• At least one solicited TEAE
• At least one IMP-related AE
• At least one treatment-emergent serious adverse event (SAE) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The overall end of the trial is defined as the date of last contact (FU-TC) for the last subject in the trial globally. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |