UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032807 |
|---|---|
| Receipt number | R000037424 |
| Scientific Title | Dupixent Special Drug Use Investigation for long term use |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2025/08/27 09:35:02 |
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Basic information
Public title
Dupixent Special Drug Use Investigation for long term use
Acronym
Dupixent Special Drug Use Investigation for long term use
Scientific Title
Dupixent Special Drug Use Investigation for long term use
Scientific Title:Acronym
Dupixent Special Drug Use Investigation for long term use
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect safety and effectiveness information of Dupixent used in the post-marketing setting in patients with atopic dermatitis not adequately controlled with existing therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: Incidence rates of adverse drug reactions, Safety specification items of Dupixent, asthma attack
Effectiveness: Investigators global assessment (IGA), Peak weekly pruritus NRS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with atopic dermatitis with inadequate response to conventional therapies
-Patients who newly start receiving the treatment with Dupixent
-Patients who can provide informed consent
Key exclusion criteria
Subjects who are participating in or have been registered for clinical trials with therapeutic intervention to Dupixent
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | SUZUKI |
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 163-1488, 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 163-1488, 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 surveillance
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
| 2018 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/jcia.2025.14794
Number of participants that the trial has enrolled
989
Results
Safety:At 2 years, the incidence rates of any ADR and serious ADRs (16.8% and 0.8%, respectively).
The most common ADRs were conjunctivitis (7.1%), allergic conjunctivitis (4.2%), and blepharitis (0.8%).
Effectiveness:At 2 years, significant improvements from baseline were observed for mean standard(deviation) EASI (from 30.1(13.2) to 4.0( 7.0), IGA (from 3.4(0.5) to 1.4(0.8)), and weekly peak pruritus NRS (from 6.9(2.1) to 1.8(1.6))scores (all P less than 0.001 vs. baseline).
Results date posted
| 2025 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 23 | Day |
Baseline Characteristics
In the publication of study results, only data from patients enrolled at participating institutions that have provided consent for publication were included.
In the safety analysis set, 679 patients (70.6%) were male, and most patients were adults (5.1% were adolescent patients aged 15-18 years. Approximately half of the safety analysis set (527 patients; 54.8%) had one or more comorbid allergic diseases at baseline; the most common were allergic rhinitis (194 patients; 20.2%), allergic conjunctivitis (139 patients; 14.4%), and asthma (104 patients; 10.8%). Among those with available data, the EASI score (mean SD) was 30.1(13.2) at baseline, and in line with clinical practice guidelines (2); most patients had IGA score 3 (460/862 patients; 53.4%) and IGA score 4 (388/862 patients; 45.0%) at dupilumab initiation.
Participant flow
989 individuals with moderate-to-severe AD who initiated treatment with dupilumab were registered in this PMS from 184 clinical sites
in Japan. Electronic CRFs were collected from 970 patients at 179 sites; after exclusions, the safety analysis set comprised 962 patients, and 892 of those were included in the effectiveness analysis set.
Adverse events
Over 2 years, ADRs were reported in 162 patients (16.8%),including eight patients (0.8%) with serious ADRs.
The most common ADRs were conjunctivitis [68 patients (7.1%), including one (0.1%) with a serious ADR], allergic conjunctivitis [40 patients (4.2%), including one (0.1%) with a serious ADR], and blepharitis [eight patients (0.8%), with no serious ADRs].
Outcome measures
Effectiveness outcomes included changes in the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and pruritus numerical rating scale (NRS) scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Patient's backgrounds, Dupixent administration status, Previous and concomitant treatments against atopic dermatitis, Concomitant medications other than Atopic dermatitis treatment, Effectiveness evaluation items for Atopic dermatitis, Biomarkers, Patients reported outcomes, etc.
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | 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=R000037424
