Phase 3
N=253
Adolescent Mite Allergy Safety Evaluation
Allergic Rhinitis · Allergic Rhinoconjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT04541004 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) — 223 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HDM SLIT-tablet (Biological)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- ALK-Abelló A/S
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) |
223 | — |
| PRIMARY Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) |
88.1 | — |
| PRIMARY Number of Treatment-emergent Adverse Events (TEAEs) |
1940 | — |
| SECONDARY Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) |
216 | — |
| SECONDARY Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) |
85.4 | — |
| SECONDARY Number of Solicited Treatment-emergent Adverse Events (TEAEs) |
1796 | — |
| SECONDARY Number of Subjects With at Least One IMP-related Adverse Event (AE) |
218 | — |
| SECONDARY Proportion of Subjects With at Least One IMP-related Adverse Event (AE) |
86.2 | — |
| SECONDARY Number of IMP-related Adverse Events (AEs) |
1863 | — |
| SECONDARY Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) |
— | — |
| SECONDARY Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) |
— | — |
| SECONDARY Number of Treatment-emergent Serious Adverse Events (SAEs) |
— | — |
Summary
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Male or female subjects aged ≥12 to ≤17 years
- A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM
- Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening
- 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
- The subject must be willing and able to comply with trial protocol and adhere to IMP treatment
Main 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 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
- 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
Data sourced from ClinicalTrials.gov (NCT04541004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.