UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052531 |
|---|---|
| Receipt number | R000059942 |
| Scientific Title | SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2026/07/25 18:22:13 |
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Basic information
Public title
SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study
Acronym
SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study
Scientific Title
SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study
Scientific Title:Acronym
SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study was to examine whether the SERPINE1 -675 4G/5G polymorphism was associated with clinical outcomes during tezepelumab treatment in adults with severe asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annualized asthma exacerbation rate (AAER) during the 52 weeks after treatment initiation.
Key secondary outcomes
Asthma exacerbation frequency during weeks 0 to 12, and ACQ-6 score, FEV1, PEF, FeNO, blood eosinophil count, and total IgE at weeks 12 and 52.
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
Patients must meet all of the following criteria
1) Patients with severe or refractory bronchial asthma whose asthma symptoms cannot be controlled by existing therapy and who will be treated with tezepelumab between the start of the study and November 1, 2024.
2) Patients 18 years of age or older.
Key exclusion criteria
Exclusion criteria
1) Patients treated with bronchial thermoplasty
2) Patients with comorbidities requiring systemic steroids or immunosuppressive agents (except when systemic steroids are used as maintenance therapy for asthma)
3) Patients who are deemed inappropriate as research subjects by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Fukahori |
Organization
Nagasaki University Hospital
Division name
Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
+81958197273
susumu-f@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Fukahori |
Organization
Nagasaki University Hospital
Division name
Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
+81958197273
Homepage URL
susumu-f@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Allergology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel
+81958197273
susumu-f@nagasaki-u.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 | 10 | Month | 18 | Day |
Related information
URL releasing protocol
https://jtd.amegroups.org/article/view/114336/html
Publication of results
Unpublished
Result
URL related to results and publications
No URL available at present because the manuscript is currently under peer review.
Number of participants that the trial has enrolled
45
Results
No consistent association was observed between the SERPINE1 -675 4G/5G genotype and 52-week clinical outcomes. In the prespecified adjusted analysis, the AAER estimate was imprecise (IRR 3.28, 95% CI 0.34-31.30; P=.302), and clinically important genotype-associated effects could not be excluded. No consistent genotype-associated differences were observed across the secondary outcomes.
Results date posted
| 2026 | Year | 07 | Month | 24 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Registration of study results was delayed because additional time was required for data analysis and manuscript preparation. Data analysis has been completed, and dissemination of the study findings is currently in progress.
Date of the first journal publication of results
Baseline Characteristics
Forty-five adults with severe asthma were enrolled and genotyped: 4G/4G, n=21; 4G/5G, n=16; 5G/5G, n=8. One 4G/5G participant was lost before week 12 and excluded from efficacy analyses. Baseline characteristics are reported for 44 participants (21/15/8): mean age 64.5+/-13.2 years; 24 women (54.5%); 14 with prior biologic exposure (31.8%); mean prior-year exacerbations, 3.3.
Participant flow
A total of 45 participants were enrolled, and baseline blood samples were obtained before tezepelumab initiation. One participant with the 4G/5G genotype was lost to follow-up before week 12 after receiving one dose of tezepelumab and had no post-baseline efficacy assessments. The remaining 44 participants completed the 52-week follow-up and were included in the efficacy analyses. Genotyping was performed after completion of follow-up in all 45 enrolled participants.
Adverse events
Adverse event data were collected according to the study protocol; however, the present analysis focused on efficacy and pharmacogenetic outcomes, and no formal adverse event analysis was conducted. Therefore, adverse event results are not reported in this study report.
Outcome measures
No consistent association was observed between the SERPINE1 -675 4G/5G genotype and 52-week clinical outcomes. In the prespecified adjusted analysis, the AAER estimate was imprecise (IRR 3.28, 95% CI 0.34-31.30; P=.302), and clinically important genotype-associated effects could not be excluded. No consistent genotype-associated differences were observed across the secondary outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059942
