Early phase II study of TAC-202 in Japanese cedar pollinosis exposure to antigen in an environmental exposure chamber.

A randomized, double-blind, 4-way crossover, placebo-controlled, phase II study to evaluate the efficacy and safety of TAC-202/bilastine in Japanese cedar pollinosis exposure to antigen in an environmental exposure chamber (EEC).

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222167

Enrollment

130

Registered

2013-08-05

Start date

2013-08-05

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

Japanese cedar pollinosis

Interventions

investigational material(s) Generic name etc : TAC-202 INN of investigational material : bilastine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects have a history of seasonal allergic rhinitis at the past 2 pollen seasons and had received medication (including oral anti-histaminic drug). Subjects between 20 and 60 years of age at the time of signing the informed consent. Subjects are available to complete all study measurements.

Exclusion criteria

Exclusion criteria: Subjects with nose, ocular or ear complications which are disturbed the assessment of efficacy for the study drug. Subjects with a history of intranasal operative treatment (coagulation necrosis or excision). Subjects with a history of specific immunotherapy (including sublingual) or nonspecific immunotherapy within 5 years prior to consent acquisition. Subjects who had treatment with steroid within 30 days prior to consent acquisition.

Design outcomes

Primary

Measure	Time frame
Efficacy (Fast action) Sum of TNSS from 0 to 3h after the first drug administration.	—

Secondary

Measure	Time frame
Efficacy (Duration of efficacy) Sum of TNSS from 22 to 26h after first drug administration.	—

Outcome results

None listed

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