A Phase 3 Study of S-524101 in the Pediatric Allergic Patients

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis

• Registration Number: JPRN-jRCT2080222929
• Lead Sponsor: Shionogi & Co., Ltd.

Brief Summary

S-524101 sublingual tablets were administered to pediatric patients with perennial allergic rhinitis due to house dust mites at the maintenance dose of 300 IR for 52 weeks. Sublingual administration of S-524101 statistically significantly improved the symptoms of house dust mite-induced allergic rhinitis compared with placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-04
• Study Completion: 2016-12-08
• Results First Posted: 2018-10-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

Patients who have a history of perennial allergic rhinitis symptom for two years or more.
Patients with a score of 3 or higher on the quantitative analysis of IgE antibody (CAP-RAST) specific to D. pteronyssinus and/or D. farinae antigens.
Patients who are positive for nasal provocation test by using allergen disc for house dust.

Exclusion Criteria

Patients with allergic rhinitis, conjunctivitis, asthma, or other symptoms due to antigens other than HDM, which could confound accurate symptom assessment during the primary evaluation period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Average Adjusted Symptom Score (AASS) during the last 4 weeks of the treatment phase (48 to 52 weeks after the initiation of administration).

Secondary Outcome Measures

Name	Time	Method
efficacy<br>AASS at each time point, Average Rhinitis Total Symptom Score, etc.