臨床研究等提出・公開システム

Date of registration	April. 22, 2023
Last modified on	Dec. 05, 2023
Trial ID	jRCT2031230051

Scientific Title	Phase 2 Allergen Challenge Trial of NTa53 in Patients with Allergic Conjunctivitis
Public Title	Phase 2 Conjunctival Allergen Challenge Trial of NTa53

Contact for Scientific Queries	Name	Hasunuma Tomoko
	Affiliation	Kitasato University Kitasato Institute Hospital
	Address	5-9-1 Shirokane,Minato-ku, Tokyo, Japan
	Telephone	+81-3-5791-6350
	E-mail	t-hasu@insti.kitasato-u.ac.jp
Contact for Public Queries	Name	Research & Development
	Affiliation	Nitto Medic Co., Ltd.
	Address	1-14-1 Yasuuchi, Yatsuo-machi, Toyama-city, Toyama, Japan
	Telephone	+81-76-455-3541
	E-mail	clinical@nittomedic.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 20, 2023
Actual date of first enrollment		June. 20, 2023
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	dose comparison control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Japanese adult between the age of 18 to under 65 years at the time of the informed consent -Specific IgE positive against cedar pollen allergens -Other protocol-specified inclusion criteria may apply
	Exclusion Criteria	-Eye disease other than allergic conjunctivitis is present and requires treatment. -Other protocol-specified exclusion criteria may apply
	Age Minimum	18age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		NTa53 and placebo administration, and allergen challenge
Primary Outcome(s)		Efficacy (Subjective Ocular Symptom Score and Objective Findings Score), Safety

Primary Sponsor	Nitto Medic Co., Ltd.

Name of Certified Review Board	The IRB of Kitasato University Shirokane Campus
Address	5-9-1 Shirokane,Minato-ku, Tokyo
Telephone	+81-3-5791-6177
E-Mail	irb-pt@insti.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	April. 14, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 05, 2023	(this page)	Changes
3	July. 11, 2023	Detail	Changes
2	June. 25, 2023	Detail	Changes
1	April. 22, 2023	Detail

List of change history