Phase II/III Clinical Trial of TO-203 -Efficacy and Safety Trial in Patients with HDM-induced Rhinitis

Phase 2

• Conditions: HDM-induced rhinitis

• Registration Number: JPRN-jRCT2080221806
• Lead Sponsor: TORII PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 900

Inclusion Criteria

(1) HDM-specific IgE antibodies >= Class 3
(2) Positive on HDM nasal provocation test
(3) Medical history of treatment for HDM-induced rhinitis
(4) Moderate or severe symptoms of HDM-induced rhinitis

Exclusion Criteria

(1) Specific IgE antibodies >= Class 5 any of the following: cedar, cypress, alder, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog hair, or cat hair
(2) Allergic rhinitis symptoms with class 2 to 4 in the specific IgE antibodies any of the following: cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog hair, or cat hair
(3) Class 2 to 4 in the specific IgE antibody to dog hair or cat hair, and no rhinitis symptoms, but constantly exposed to the relevant animal (e.g., pet parenting at home, working at a pet shop)
(4) Patients who received immunotherapy with HDM allergen-containing products (e.g., house dust) for at least 1 month during 5 years before the first day of observation.
(5) Patients who are on immunotherapy other than HDM allergen-containing products on the first day of observation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified