UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044672 |
|---|---|
| Receipt number | R000051018 |
| Scientific Title | Comparative Efficacy and Safety of Tezepelumab and Dupilumab in Patients with Inadequately Controlled Asthma According to Thresholds of Type 2 Inflammatory Biomarkers: A Systematic Review and Network Meta-Analysis |
| Date of disclosure of the study information | 2021/06/28 |
| Last modified on | 2022/01/24 16:19:54 |
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Basic information
Public title
Comparative Efficacy and Safety of Tezepelumab and Dupilumab in Patients with Inadequately Controlled Asthma According to Thresholds of Type 2 Inflammatory Biomarkers: A Systematic Review and Network Meta-Analysis
Acronym
Tezepelumab versus Dupilumab in asthma
Scientific Title
Comparative Efficacy and Safety of Tezepelumab and Dupilumab in Patients with Inadequately Controlled Asthma According to Thresholds of Type 2 Inflammatory Biomarkers: A Systematic Review and Network Meta-Analysis
Scientific Title:Acronym
Tezepelumab versus Dupilumab in asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety for inadequately controlled asthma between tezepelumab and existing biologics
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annualized exacerbation rate
Key secondary outcomes
Change in pre-bronchodilator Fev1.0
ACQ score
AQLQ score
incidence of any adverse events
Base
Study type
Others,meta-analysis etc
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
| 12 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients
The inclusion criteria are as follows:
(1) A minimum age of 12 years,
(2) Inadequately controlled asthma requiring moderate-to-high doses of ICS
(3) At least one episode of exacerbation in the previous year.
2. Interventions and Comparisons
The NMA planned to include data for tezepelumab (210 mg, subcutaneously, once every 4 weeks), dupilumab (300 mg, subcutaneously, once every 2 weeks), benralizumab (30 mg, subcutaneously, once every 8 weeks after the first three doses administered once every 4 weeks), and mepolizumab (100 mg, subcutaneously, once every 4 weeks).
Key exclusion criteria
Patients under 12 years old
Non-RCTs, phase 1, 2 or, non-phase 3 RCTs, case-control studies, and cohort studies.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8532
koichi-a@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
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
Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel
03-3784-8532
koichi-a@med.showa-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
| 2021 | Year | 06 | Month | 28 | 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
5524
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This systematic review and network meta-analysis will compare the efficacy and safety of tezepelumab versus dupilumab for inadequately controlled asthma.
Management information
Registered date
| 2021 | Year | 06 | Month | 27 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051018
