UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Study to Identify Efficacy, Safety, and Predictors of Tezepelumab in Severe Asthma
Acronym	J-EAST
Scientific Title	Prospective Study to Identify Efficacy, Safety, and Predictors of Tezepelumab in Severe Asthma
Scientific Title:Acronym	J-EAST
Region	Japan

Condition
Condition	asthma, bronchial asthma
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy, safety, and predictors of efficacy of tezepelumab in severe asthma in a real-world clinical setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Predictors of efficacy before treatment and improvement in symptoms after 16 weeks
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed with severe asthma according to the Comprehensive Allergy Guidelines 2022 2) Patients with severe bronchial asthma who are using high-dose inhaled steroids and long-acting beta2-stimulants 3) Patients who give written consent to participate in this study 4) Patients 20 years of age or older
Key exclusion criteria	1) Patients with a history of previous administration of tezepelumab (2) Patients with serious complications such as cardiac, hepatic, or renal disease (3) Patients who are judged to be inappropriate for the subject by the physician's judgment.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takehiro Middle name Last name Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Zip code	150-8935
Address	4-1-22, Hiroo Shibuya-ku, Tokyo
TEL	03-3400-1311
Email	izumo_takehiro@med.jrc.or.jp

Public contact
Name of contact person	1st name Takehiro Middle name Last name Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Zip code	150-8935
Address	4-1-22, Hiroo Shibuya-ku, Tokyo
TEL	03-3400-1311
Homepage URL
Email	drtake1118@gmail.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Medical Center
Address	4-1-22, Hiroo Shibuya-ku, Tokyo
Tel	03-3400-1311
Email	drtake1118@nu2.so-net.ne.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 10 Month 20 Day
Date of IRB	2022 Year 11 Month 16 Day
Anticipated trial start date	2022 Year 11 Month 20 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2022 Year 11 Month 20 Day
Last modified on	2022 Year 11 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056448