UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052764 |
|---|---|
| Receipt number | R000060211 |
| Scientific Title | Development of a biomarker for predicting the clinical effectiveness of tezepelumab in patients with severe asthma and elucidation of immunomodulatory effects of tezepelumab |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2023/11/10 23:14:51 |
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Basic information
Public title
Development of a biomarker for predicting the clinical effectiveness of tezepelumab in patients with severe asthma and elucidation of immunomodulatory effects of tezepelumab
Acronym
Tokyo Asthma Study for Tezepelumab: TOAST2
Scientific Title
Development of a biomarker for predicting the clinical effectiveness of tezepelumab in patients with severe asthma and elucidation of immunomodulatory effects of tezepelumab
Scientific Title:Acronym
Tokyo Asthma Study for Tezepelumab: TOAST2
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to develop a new biomarker useful for predicting the therapeutic effect of the humanized anti-TSLP (Thymic stromal lymphopoietin) monoclonal antibody preparation tezepelumab, and to elucidate of the immunomodulatory effects of tezepelumab.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the changes from baseline in secondary endpoints due to tezepelumab treatment (amount of change or rate of change) up to Week 24 and Week 52 of tezepelumab treatment, and the association between these items.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline in the cell ratio of each peripheral blood immunocompetent cell population (eosinophils, etc.) due to tezepelumab administration up to 24 weeks of tezepelumab treatment for patients with severe asthma that is difficult to control with existing treatments.
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
Subjects with refractory asthma whose asthma symptoms cannot be controlled by existing treatments and who require tezepelumab treatment under insurance according to the package insert.
Subjects receiving treatment with moderate to high doses of inhaled corticosteroids plus at least one controller.
Subjects who meet at least one of the following criteria at baseline:
(1) At least one exacerbation of asthma has been observed within the past 2 years
(2) ACQ-6 score 1.5 or higher or ACT score 20 or lower
(3) FEV1 before bronchodilator administration is less than 80% of the predicted value
Key exclusion criteria
Subjects with malignancy
Current smokers and subjects with a history of smoking within the past 6 months
Subjects receiving treatment with other biologics and less than 1 month since last administraion (benralizumab requires 2 months)
Subjects who have received bronchial thermoplasty within the past 6 months
Subjects with a history of anaphylaxis due to biologics
Subjects currently pregnant or breastfeeding
Subjects with chronic obstructive pulmonary disease with obvious emphysematous changes
Subjects with hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, pulmonary hypertension, sequelae of tuberculosis, diffuse panbronchiolitis, and interstitial pneumonia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Harada |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
nor@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Harada |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
nor@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.ac.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
日本大学医部附属板橋病院（東京都）
東京医科歯科大学病院（東京都）
仁友クリニック（東京都）
昭和大学病院（東京都）
東京医科大学病院（東京都）
東京慈恵会医科大学附属病院（東京都）
慶應義塾大学病院（東京都）
帝京大学医学部内科学講座（東京都）
東京女子医科大学病院（東京都）
独立行政法人国立病院機構 東京病院（東京都）
国立国際医療研究センター病院（東京都）
国際医療福祉大学医学部附属三田病院（東京都）
社会医療法人社団順江会江東病院（東京都）
独立行政法人国立病院機構災害医療センター（東京都）
順天堂大学医学部附属浦安病院（千葉県）
順天堂大学医学部附属順天堂東京江東高齢者医療センター（東京都）
順天堂大学医学部附属練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The method of recruitment;
Subjects who meet any inclusion criteria will be recruited from study participating facilities, including outpatient clinic at Juntendo University Hospital, by March 31, 2026.
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060211
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
