UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050670 |
|---|---|
| Receipt number | R000057732 |
| Scientific Title | Exploration of biomarkers to predict the effects of anti TSLP antibody (Tezepelumab) in refractory asthma patients using comprehensive analyses of changes in gene expression in whole blood cells |
| Date of disclosure of the study information | 2023/04/21 |
| Last modified on | 2023/04/21 17:05:06 |
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Basic information
Public title
Exploration of biomarkers to predict the effects of anti TSLP antibody (Tezepelumab) in refractory asthma patients using comprehensive analyses of changes in gene expression in whole blood cells
Acronym
Exploration of biomarkers to predict the effects of anti TSLP antibody (Tezepelumab) in refractory asthma patients using comprehensive analyses of changes in gene expression in whole blood cells
Scientific Title
Exploration of biomarkers to predict the effects of anti TSLP antibody (Tezepelumab) in refractory asthma patients using comprehensive analyses of changes in gene expression in whole blood cells
Scientific Title:Acronym
Exploration of biomarkers to predict the effects of anti TSLP antibody (Tezepelumab) in refractory asthma patients using comprehensive analyses of changes in gene expression in whole blood cells
Region
| Japan |
Condition
Condition
Severe asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze association between gene expression data from whole blood cells and effect of Tezepelumab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
During a 4-month observation period (up to 1 year), all participants will be divided into treatment responders and non-responders using FEV1.0, ACT score, GETE score, and frequency of acute exacerbations.
Key secondary outcomes
1, To analyze association between gene expression data from whole blood cells and effect of Tezepelumab, first, the difference in baseline gene expression between the responder and non-responder groups will be analyzed. In addition, changes in gene expression will be analyzed before and after tezepelumab treatment in the responder group and non-responder group, or in all patients. Thereafter, a cluster analysis will be performed by integrating gene sets with changes and clinical information.
2, If important genes involved in treatment response are identified, serum protein concentrations will be measured to determine whether these can be used as biomarkers.
3, To analyze the difference in the effect of Tezepelumab between type2 severe asthma patients and non-type 2 severe asthma patients in terms of clinical and gene expression information.
4, To clarify the effect of tezepelumab in terms of TSLP genetic polymorphisms.
5, Furthermore, using the R package, Coexpression analysis and consensus clustering will be performed, and analysis that is not bound by existing clinical information will also be performed. And the correlation between genetic information and clinical information will be analyzed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Severe asthma patients with 18 years or older who are scheduled to receive tezepelumab based on phsician's judge. And Tezepelumab will be treated according to the package insert
2. Patients who agree to receive tezepelumab in advance as a result of consultations with the attending physician
Key exclusion criteria
1. Patients with serious complications such as uncontrolled heart disease, diabetes mellitus, or gastrointestinal hemorrhage
2. Patients with active local or systemic infection requiring treatment
3. Patients with a history of serious hypersensitivity
4. Patients whose enrollment in this study is considered to be difficult due to clinically significant psychiatric disorders
5. Other patients considered ineligible for this study by the principal investigator/sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Matsuyama |
Organization
Tsukuba university hospital
Division name
Department of Respiratory Medicine
Zip code
3058575
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3144
mmatsuyama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Matsuyama |
Organization
Tsukuba university hospital
Division name
Department of Respiratory Medicine
Zip code
3058575
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3144
Homepage URL
mmatsuyama@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba clinical research and development organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 21 | 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
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
The integration of information from molecular genetic analyses, such as comprehensive analyses of gene expression and analyses of gene polymorphisms, may reveal not only unknown mechanisms of action of Tezepelumab but may also lead to the elucidation of the pathophysiological mechanisms of severe asthma (particularly, non-type 2 severe asthma).
Management information
Registered date
| 2023 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057732
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