臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 06, 2024
Last modified on	Dec. 27, 2024
Trial ID	jRCTs031240259

Scientific Title	BENralizumab dosing interval Extension to 12 weeks in severe asthma patients; a multicenter phase II study to evaluate the safety and efFIcacy (BENEFIT trial)
Public Title	Testing Safe Extension of Benralizumab Dosing Intervals (BENEFIT trial)

Contact for Scientific Queries	Name	Kaneko Takeshi
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura Kanazawaku Yokohama Kanagawa
	Telephone	+81-45-787-2800
	E-mail	takeshi@yokohama-cu.ac.jp
Contact for Public Queries	Name	Kobayashi Nobuaki
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura Kanazawaku Yokohama Kanagawa
	Telephone	+81-45-787-2800
	E-mail	nkobayas@yokohama-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 06, 2024
Actual date of first enrollment		Nov. 22, 2024
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Diagnosis of bronchial asthma and continuous treatment with benralizumab for at least 1 year prior to study initiation. (2) No more than 1 asthma exacerbation in the past year. (3) No asthma exacerbations within the past 3 months. (4) No increase in controller medication dosage due to symptom worsening in the past year (dose reductions or discontinuations of controllers are permitted). (5) Age 18 years or older. (6) Provision of written informed consent to participate in this study.
	Exclusion Criteria	(1) Current or prior use of other biologic agents for asthma within the past 1 year. (2) History of severe asthma exacerbation requiring mechanical ventilation. (3) Pregnant or lactating women, those with a possibility of being pregnant, or those who desire to become pregnant during the treatment period. (4) Patients with a potential for parasitic infection. (5) Any other patients deemed ineligible for the study based on the investigator's clinical judgment.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		asthma
Intervention(s)		Benralizumab (trade name: Fasenra subcutaneous injection) will be administered as a 30 mg subcutaneous injection every 12 weeks.
Health Condition(s) Keyword		asthma
Intervention(s) Keyword
Health Condition(s) Code		D001249
Intervention(s) Code		D018927
Primary Outcome(s)		Annual asthma exacerbation rate (total number of exacerbations x 365.25 / total treatment period follow-up duration in days)
Secondary Outcome(s)		Efficacy Endpoints: Asthma Control Questionnaire (ACQ) score, comprising 7 items assessing asthma-related symptoms Forced Expiratory Volume in 1 second (FEV1) Peripheral blood eosinophil count Fractional exhaled nitric oxide (FeNO) Oral corticosteroid (OCS) dose Changes in asthma controller medication Safety Endpoint: Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Yokohama City University Certified Institutional Review Board
Address	3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa
Telephone	+81-45-370-7627
E-Mail	ycu_crb@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	June. 06, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Dec. 27, 2024	(this page)	Changes
2	Dec. 12, 2024	Detail	Changes
1	Aug. 06, 2024	Detail

List of change history