UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061347 |
|---|---|
| Receipt number | R000070175 |
| Scientific Title | A prospective, single-arm, pre-post observational study evaluating the impact of switching from mepolizumab to depemokimab on patient-reported outcomes, including treatment satisfaction, convenience, and quality of life, in patients with severe eosinophilic asthma |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/22 09:14:12 |
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Basic information
Public title
A prospective, single-arm, before-and-after comparative study evaluating the impact of switching from mepolizumab to depemokimab on patient satisfaction, treatment convenience, and quality of life in patients with severe eosinophilic asthma
Acronym
Depemokimab Switch PRO Study
Scientific Title
A prospective, single-arm, pre-post observational study evaluating the impact of switching from mepolizumab to depemokimab on patient-reported outcomes, including treatment satisfaction, convenience, and quality of life, in patients with severe eosinophilic asthma
Scientific Title:Acronym
DeSwitch-PRO Study
Region
| Japan |
Condition
Condition
severe asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the impact of switching from an IL-5 antibody (mepolizumab) to depemokimab on patient satisfaction, treatment convenience, quality of life, and asthma control in patients with severe eosinophilic asthma currently being treated with mepolizumab
Basic objectives2
Others
Basic objectives -Others
This study further aims to evaluate the impact of improved treatment convenience on patient satisfaction and quality of life (QOL), as well as to generate real-world data that can inform the selection of biologics in clinical practice. Additionally, we will conduct an exploratory analysis of the influence of patient background factors on changes in treatment satisfaction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in the TSQM-9 Convenience score at Week 26
Key secondary outcomes
1. Changes in TSQM-9 Global Satisfaction and Effectiveness
2. Changes in ACT and mini-AQLQ scores
3. PGIC assessment
4. Number of asthma exacerbations
5. Changes in FEV1, FeNO, and blood eosinophil count
6. Safety (adverse events)
7. Assessment of treatment retention rate
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with severe eosinophilic asthma who are currently receiving outpatient care at Himeji St. Mary's Hospital, St. Francis Society Social Medical Foundation, between the date of study approval and March 31, 2027, and who have been using an IL-5 antibody (mepolizumab) for at least 6 months
2. Patients aged 18 years or older
3. Patients who can provide informed consent to participate in the study of their own free will
4. Patients scheduled to switch to depemokimab
Key exclusion criteria
1. Patients who declined to participate in this study
2. Patients whom the principal investigator deemed unsuitable for this study
3. Patients currently participating in clinical trials of other drugs or medical devices
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
6700801
Address
650 Nibuno, Himeji, Hyogo, Japan
TEL
0792655111
nakajima-y@himemaria.or.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
6700801
Address
650 Nibuno, Himeji, Hyogo, Japan
TEL
0792655111
Homepage URL
y0a1s0u7@gmail.com
Sponsor or person
Institute
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
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
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Address
650 Nibuno, Himeji, Hyogo, Japan
Tel
0792655111
di@himemaria.or.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
| 2026 | Year | 04 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Objective
Change from baseline in the TSQM-9 Convenience score at Week 26
Secondary Objectives
1. Changes in TSQM-9 Global Satisfaction and Effectiveness
2. Changes in ACT and mini-AQLQ scores
3. PGIC assessment
4. Number of asthma exacerbations
5. Changes in FEV1, FeNO, and blood eosinophil count
6. Safety (adverse events)
7. Assessment of treatment retention rate
Exploratory Objectives
To evaluate the influence of baseline demographic factors (age, BMI, duration of prior medication use, etc.) on the change in the primary endpoint (TSQM-9 Convenience)
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070175
