Phase III clinical trial of TO-203 - Evaluation of efficacy and safety in pediatric patients with HDM-induced allergic rhinitis
- Conditions
- Allergic rhinitis
- Registration Number
- JPRN-jRCT2080222901
- Lead Sponsor
- TORII PHARMACEUTICAL CO., LTD.
- Brief Summary
In pediatric subjects aged 5 to 17 years, the superiority of the TO-203 sublingual tablet 10,000 JAU to placebo was confirmed. It was considered that the TO-203 sublingual tablet 10,000 JAU has a favorable safety profile in pediatric subjects aged 5 to 17 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 458
(1) Patients with HDM-specific IgE : class 3 or more.
(2) Patients with positive nasal provocation test.
(3) Patients with a history of prescription drug treatment for perennial allergic rhinitis.
(4) Patients with moderate or severe symptoms of HDM-induced allergic rhinitis.
(1) Patients with class 5 or more in the specific-IgE antibody tests to any of the following: cedar, cypress, alder, Betula, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog dander, or cat dander.
(2) Patients with class 2 to 4 in the specific-IgE antibody tests to any of the following: cedar, cypress, alder, Betula, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog dander, or cat dander, and who have symptoms of allergic rhinitis due to these relevant antigen
(3) Patients with class 2 to 4 in the specific-IgE antibody tests to dog dander or cat dander, and who have no symptoms of allergic rhinitis, while being constantly exposed to these relevant animal (e.g., pet parenting at home)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method