臨床研究等提出・公開システム

Japanese

Date of registration	May. 19, 2025
Last modified on	Sept. 25, 2025
Trial ID	jRCT2041250027

Scientific Title	TO-209 Phase III Clinical Trial - Investigation of Efficacy and Safety in Patients with Grass Pollinosis -
Public Title	TO-209 Phase III Clinical Study

Contact for Scientific Queries	Name	Kikuchi Masayo
	Affiliation	Torii Pharmaceutical Co.,Ltd.
	Address	4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo 103-8439, Japan
	Telephone	+81-80-1316-6600
	E-mail	masayo.kikuchi@torii.co.jp
Contact for Public Queries	Name	Kikuchi Masayo
	Affiliation	Torii Pharmaceutical Co.,Ltd
	Address	4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo 103-8439, Japan
	Telephone	+81-80-1316-6600
	E-mail	masayo.kikuchi@torii.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 01, 2025
Actual date of first enrollment		June. 06, 2025
Target sample size		760
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Men and women aged >= 5 years to < 65 years on the day of informed consent -Patients who meet either A and/or B in these tests conducted on the first day of observation (Visit 1) 1) "Phleum pratense (Timothy) pollen-specific IgE antibody test >= Class 2" and "positive skin prick test (Timothy) 2) "Orchard pollen-specific IgE antibody test >= Class 2" and "positive skin prick test (Orchard)". -Patients who experienced any moderate to severe nasal symptoms of nasal discharge, nasal congestion, sneezing, or pruritus (with a total nasal symptom score of >= 7) as well as any mild to severe ocular symptoms of foreign body sensation/hyperemia/pruritus in the eye or lacrimation (with a total ocular symptom score of >= 1) in locations with weeds, such as dry riverbeds, fields, farmlands, and vacant lots, during the grass pollen season (Hokkaido: Jun, Tohoku, Kanto, Chubu, Kinki, Chugoku, Shikoku, Kyushu: May-Jun) for >= 2 years consecutively, including the year of the starting day of observation (Visit 1), and who required drug therapy.
	Exclusion Criteria	-Patients with specific IgE antibody test results of Class 5 or higher for any of the following: Japanese cypress, alder, white birch, ragweed, Dermatophagoides pteronyssinus, dog dander, cat dander, cockroach, moth, Candida, Aspergillus, and Alternaria measured on the starting day of observation (Visit 1) -Patients with specific IgE antibody test results of Class 2-4 for dog dander and cat dander measured on the starting day of observation (Visit 1) who experienced allergic rhinitis due to the antigens -Patients with specific IgE antibody test results of Class 2-4 for dog dander and cat dander measured on the starting day of observation (Visit 1) who showed no symptoms of allergic rhinitis due to the antigens while being exposed to the animals on a daily basis (e.g., have a dog(s)/cat(s) at home, work at a pet shop) -Patients having daily contact with the pet(s) fed by timothy and/or orchard -Patients who experienced seasonal allergic rhinitis or conjunctivitis symptoms caused by other allergens during the grass pollen season (between May and June) and required medication -Patients with comorbidities such as drug-induced rhinitis, vasomotor rhinitis, or non-allergic rhinitis -Patients with following asthma; 1) Asthma requiring high daily doses of inhaled corticosteroids within 6 months prior to the randomisation (Visit 2) 2) Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 6 months prior to randomisation (Visit 2) -Patients who received specific or non-specific immunotherapy for grass pollinosis, as indicated below: 1) Patients who received specific immunotherapy for grass pollinosis for at least 1 month within 5 years before the starting day of observation (Visit 1) 2) Patients who received non-specific immunotherapy between 5 years before the starting day of observation (Visit 1) and the starting day of observation (Visit 1) 3) Patients who have initiated specific immunotherapy for allergic symptoms caused by mite allergens within 1 year before the starting day of observation (Visit 1) 4) Patients who have initiated specific immunotherapy for allergic symptoms caused by Japanese cedar pollen in 2025
	Age Minimum	5age old over
	Age Maximum	64age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Grass Pollinosis
Intervention(s)		To conduct a randomized, double-blind, placebo-controlled trial of TO-209 sublingual administration in patients 5-64 years of age with grass pollinosis to verify the superiority of TO-209 to placebo using the total rhinoconjunctivitis symptoms and medication score as the primary endpoint and to investigate its safety.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Average daily Total combined rhinoconjunctivitis symptom score and rhinoconjunctivitis medication score during period A
Secondary Outcome(s)		-Average daily Total combined rhinoconjunctivitis symptom score and rhinoconjunctivitis medication score during period B -Average daily rhinoconjunctivitis score during period A, period B -Average daily rhinoconjunctivitis medication score during period A, period B -Average daily rhinitis score during period A, period B -Average daily rhinitis medication score during period A, period B -Average daily Total combined rhinitis score during period A, period B -Average daily conjunctivitis score during period A, period B -Average daily conjunctivitis medication score during period A, period B -Average daily Total combined conjunctivitis score during period A, period B -JRQLQ No.1 (23-May-2026, 23-Jun-2026) -Physician's and subject's global evaluation

Primary Sponsor	Torii Pharmaceutical Co.,Ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	JA Shizuoka kohseiren Enshu Hospital Institutional Review Board
Address	1-1 Chuo 1-chome, Chuo-ku, Hamamatsu-shi, Shizuoka-ken, Japan, Shizuoka
Telephone	+81-53-453-1111
E-Mail	chiken2.ken@shizuokakouseiren.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	General Incorporated Association Nihon Hospital Alliance (NHA) Central Institutional Review Board
Address	5-34-7 Shiba Minato-ku, Tokyo, Shizuoka
Telephone	+81-3-6779-8166
E-Mail	nha.chiken@nha-gpo.or.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Shizuoka
Telephone	+81-3-6665-0572
E-Mail	soudan@hurecs.org
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Takahashi Medical Clinic Institutional Review Board
Address	Chisaka dai1 Bld. 1F 6-2-6, HigashiKoigakubo, Kokubunji-shi, Tokyo, Japan, Shizuoka
Telephone	+81-42-322-7676
E-Mail	jimukyoku@medireco.co.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Kyoyukai RiverSide Clinic Institutional Review Board
Address	Riverside Apartments No.2 2-1 west, 7 South, Chuo-ku, Sapporo-shi, Hokkaido, Japan, Shizuoka
Telephone	+81-11-521-2321
E-Mail	fukui@hokutopharma.co.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Japanese Red Cross Shizuoka Hospital IRB
Address	8-2 Otemachi, Aoi-ku, Shizuoka City, Shizuoka Prefecture, Shizuoka
Telephone	+81-54-254-4311
E-Mail	chiken-srhpp@shizuoka-med.jrc.or.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Institutional Review Board of Tohoku Medical and Pharmaceutical University Hospital
Address	1-12-1 Fukumuro, Miyagino-ku, Sendai City, Miyagi, Japan, Shizuoka
Telephone	+81-22-259-1221
E-Mail	tikenn@hosp.tohoku-mpu.ac.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Osaka Habikino Medical Center Institutional Review Board
Address	3-7-1,Habikino,Habikino-City,Osaka, Shizuoka
Telephone	+81-72-957-2121
E-Mail
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	National Hospital Organization Fukuoka National Hospital Institutional Review Board
Address	4-39-1, Yakatabaru, Minami-ku, Fukuoka-shi, Fukuoka, 811-1394, Japan, Shizuoka
Telephone	+81-92-565-5534
E-Mail	603-chiken@mail.hosp.go.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Sugiura Clinic Institutional Review Board
Address	4-4-16-301, Hon-cho, Kawaguchi-shi, Saitama-ken, Shizuoka
Telephone	+81-42-648-5551
E-Mail	sugiura-irb@eps.co.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Oita University Hospital Institutional Review Board
Address	1-1, idaigaoka,Hasama-machi, Yufu, Oita, Shizuoka
Telephone	+81-97-586-6163
E-Mail	gcrcjimu@oita-u.ac.jp
Approval Status
Date of approval	May. 08, 2025

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara,Yodogawa-ku,Osaka-shi,Osaka 532-0003 JAPAN, Shizuoka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	May. 08, 2025

Name of Certified Review Board	Mizuo Clinic Institutional Review Board
Address	Wisteria-kan 1F, 3-9-1, Nakataminami, Izumi-ku, Yokohama, Kanagawa, Japan, Kanagawa, Shizuoka
Telephone	+81-3-5295-0147
E-Mail	info@mizuo-irb.jp
Approval Status
Date of approval	May. 08, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 25, 2025	(this page)	Changes
3	July. 31, 2025	Detail	Changes
2	June. 09, 2025	Detail	Changes
1	May. 19, 2025	Detail

List of change history