UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036992 |
|---|---|
| Receipt number | R000042144 |
| Scientific Title | Dupixent Specified Drug Use Investigation for long term use (Asthma) |
| Date of disclosure of the study information | 2019/06/07 |
| Last modified on | 2025/08/27 10:40:17 |
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Basic information
Public title
Dupixent Specified Drug Use Investigation for long term use (Asthma)
Acronym
Dupixent Specified Drug Use Investigation for long term use (Asthma)
Scientific Title
Dupixent Specified Drug Use Investigation for long term use (Asthma)
Scientific Title:Acronym
Dupixent Specified Drug Use Investigation for long term use (Asthma)
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect the safety information of long term use of Dupixent for 1 year in Japanese patients with asthma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: Occurrence of cases of eosinophilia over 5000/micro L, and eosinophilia with clinical symptoms
Key secondary outcomes
Safety: Occurrence of adverse drug reactions
Effectiveness: Severe asthma exacerbation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients who meet criteria for treatment with dupixent for their asthma according to the indication in Japanese labeling (severe or intractable asthmatic patients with inadequate control in conventional therapies)
-Patients who newly start receiving the treatment with Dupixent
-Patients who can provide informed consent
Key exclusion criteria
-Patients who have been administered Dupixent in the past
-Patients who are participating in or have been registered for clinical trials with therapeutic intervention of Dupixent
-Patients with a history of hypersensitivity to the ingredients of Dupixent
-Patients who are contraindicated in the package insert of Dupixent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | TAMURA |
Organization
Sanofi K.K.
Division name
Post-authorization regulatory studies, Medical Affairs
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-3867
Sanofi_Medical@sanofi.com
Public contact
Name of contact person
| 1st name | Public contact for Drug use surveillance |
| Middle name | |
| Last name | - |
Organization
Sanofi K.K.
Division name
Post-authorization regulatory studies, Medical Affairs
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-3867
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
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
Not applicable because of Drug use results survey
Address
-
Tel
-
-
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
| 2019 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.resinv.2025.05.015
Number of participants that the trial has enrolled
390
Results
Safety: ADRs were reported in 37 patients (9.8 %) during the observation period. Among these, five patients (1.3 %) reported serious ADRs.
Effectiveness: Among the effectiveness analysis population, the LSM (95 % CI) frequency of severe asthma exacerbations in the year before and after dupilumab initiation was 1.48 (1.26-1.73) versus 0.25 (0.20-0.31) events per year, respectively (IRR, 0.17; 95 % CI 0.14-0.20; P less than 0.001) in regression analyses.
Results date posted
| 2025 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 27 | Day |
Baseline Characteristics
At baseline, 57.7 % of patients were female, the mean (SD) age was 57.8 (19.4) years (range, 12-89 years), 171 patients (45.5 %) were aged 65 years and older and most patients (80.3 %) had severe persistent asthma.
Participant flow
390 patients with moderate-to- severe asthma initiated dupilumab treatment and were registered from 129 clinical sites in Japan. Data from 382 patients were inputted into the EDC; after exclusions, 376 patients were included in the safety analysis population and 373 in the effectiveness analysis population.
Adverse events
ADRs were reported in 37 patients (9.8 %) during the observation period. Among these, five patients (1.3 %) reported serious ADRs, which included eosinophilic pneumonia in two patients (0.5 %) and EGPA, increased eosinophil count, mononeuropathy multiplex and cancer pain in one patient each (0.3 %).
Outcome measures
Effectiveness was assessed through the incidence and frequency of severe asthma exacerbations.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 17 | Day |
Other
Other related information
Patient's backgrounds, Dupixent administration status, Previous and concomitant treatments against asthma, Concomitant medications other than Asthma treatment, Medical history, Complications, Effectiveness evaluation item for Asthma, etc.
Management information
Registered date
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042144
