UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036302 |
|---|---|
| Receipt number | R000041286 |
| Scientific Title | Biomarkers predictive for clinical efficacy of anti-interleukin-4/13 receptor monoclonal antibody in patients with asthma |
| Date of disclosure of the study information | 2019/03/27 |
| Last modified on | 2025/03/31 09:44:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Biomarkers predictive for clinical efficacy of anti-interleukin-4/13 receptor monoclonal antibody in patients with asthma
Acronym
Biomarkers for anti-interleukin-4/13 receptor alpha monoclonal antibody
Scientific Title
Biomarkers predictive for clinical efficacy of anti-interleukin-4/13 receptor monoclonal antibody in patients with asthma
Scientific Title:Acronym
Biomarkers for anti-interleukin-4/13 receptor alpha monoclonal antibody
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Biomarkers predictive for clinical efficacy of anti-IL-4/13 receptor monoclonal antibody in patients with asthma
Basic objectives2
Others
Basic objectives -Others
Biomarkers for clinical efficacy of anti-IL-4/13 receptor monoclonal antibody in patients with asthma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomarker discovery for clinical efficacy of anti-IL-4/13 receptor monoclonal antibody
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
-Subject is diagnosed with asthma according to the Japanese Asthma Prevention and Management Guidelines (JGL).
-Participant demonstrates understanding and has provided an appropriately signed and dated informed consent
Key exclusion criteria
Exclusion criteria included COPD, interstitial pneumonia, infectious disease, and active cancer.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Harada |
Organization
Juntendo University school of medicine
Division name
Department of respiratory medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
nor@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Harada |
Organization
Juntendo University school of medicine
Division name
Department of respiratory medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
nor@juntendo.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Sanofi K.K.
IRB Contact (For public release)
Organization
Juntendo University Research Ethics Committee
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
chiken@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
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
| 2019 | Year | 03 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
The method of recruitment;
Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital by March 31, 2026.
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041286
