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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222929

Enrollment

400

Registered

2015-08-04

Start date

2015-10-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perennial Allergic Rhinitis

Interventions

investigational material(s) Generic name etc : S-524101 INN of investigational material : - Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
efficacy Average Adjusted Symptom Score (AASS) during the last 4 weeks of the treatment phase (48 to 52 weeks after the initiation of administration).	—

Secondary

Measure	Time frame
efficacy AASS at each time point, Average Rhinitis Total Symptom Score, etc.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026