Phase II/III clinical trial of TO-206 - Evaluation of efficacy and safety in patients with Japanese cedar pollinosis

Not Applicable

Completed

• Conditions: Japanese cedar pollinosis

• Registration Number: JPRN-jRCT2080222528
• Lead Sponsor: Torii Pharmaceutical Co., Ltd.

Brief Summary

This study results demonstrated the superiority of three active doses of TO-206 2,000 JAU, 5,000 JAU and 10,000 JAU to placebo. 5,000 and 10,000 JAU indicated the same degree of efficacy and statistically significant differences to 2,000 JAU was revealed. The optimal dose was determined to be 5,000 JAU. The effect of TO-206 5,000 JAU was maintained for 2 years after the end of administration. TO-206 5,000 JAU showed favorable safety profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-18
• Results First Posted: 2019-04-30
• Study Completion: 2019-06-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 1042

Inclusion Criteria

1)Patients with specific IgE against cedar pollen : class 3 or more.
2)Patients who have a clinical history of cedar pollinosis in 2013 and 2014 cedar pollen seasons.

Exclusion Criteria

1)Patients with perennial allergic rhinitis, medication-derived rhinitis, vasomotor rhinitis or non-allergic rhinitis during therapy.
2)Patients who have developed asthmatic attack within 5 years before the pre-treatment observation visit.
3)Patients who have received specific immunotherapy for cedar pollinosis in history.

Study & Design

• Study Type: Interventional
• Study Design: Not specified