UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059706 |
|---|---|
| Receipt number | R000068288 |
| Scientific Title | Efficacy, Safety, and Biomarker Exploration of Mepolizumab Therapy for Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis: A Prospective Multicenter Cohort Study |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/11/09 15:34:52 |
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Basic information
Public title
Efficacy, Safety, and Biomarker Exploration of Mepolizumab Therapy for Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis: A Prospective Multicenter Cohort Study
Acronym
Exploration of Clinical Biomarkers for Mepolizumab Therapy in Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis
Scientific Title
Efficacy, Safety, and Biomarker Exploration of Mepolizumab Therapy for Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis: A Prospective Multicenter Cohort Study
Scientific Title:Acronym
Exploration of Clinical Biomarkers for Mepolizumab Therapy in Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis
Region
| Japan |
Condition
Condition
Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively investigates the clinical outcomes of mepolizumab treatment in patients with postoperative recurrent eosinophilic chronic rhinosinusitis. We aim to evaluate whether mepolizumab improves patients' quality of life. Furthermore, by analyzing the backgrounds and clinical courses of patients who respond favorably to mepolizumab, we seek to identify clinical characteristics associated with treatment efficacy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A The following scores and subjective symptoms will be evaluated over time
Nasal obstruction visual analogue scale VAS score 0 10
Nasal polyp score Each nasal cavity will be scored from 0 to 4 total score 0 8
Overall nasal symptom self assessment based on the baseline Patients will subjectively evaluate their overall nasal symptoms including nasal obstruction nasal discharge and olfactory disturbance as worsened no change slightly improved or significantly improved
B At week 24 of treatment patients who rate their overall nasal symptoms as slightly improved or significantly improved in the self assessment will be classified as responders while the remaining patients will be classified as non responders
Factors associated with treatment responsiveness will be analyzed as follows
Clinical factors
Age
Sex
Presence or absence of other immunoallergic diseases eg bronchial asthma NSAID exacerbated respiratory disease NSAID hypersensitivity atopic dermatitis allergic rhinitis etc
History of dupilumab treatment
Tissue eosinophil count evaluated using biopsy or surgical specimens obtained prior to mepolizumab administration
Peripheral blood eosinophil count percent cells uL assessment time points specified
Serum total IgE IU mL assessment time points specified
Location of recurrent nasal polyps middle meatus olfactory cleft or sphenoethmoidal recess
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
| 12 | years-old | <= |
Age-upper limit
| 130 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with postoperative recurrent eosinophilic chronic rhinosinusitis who are currently receiving or scheduled to receive treatment with mepolizumab.
Among those, patients who have received a full explanation of the study and have provided written informed consent will be included.
Key exclusion criteria
Patients who are already receiving mepolizumab treatment for bronchial asthma or eosinophilic granulomatosis with polyangiitis.
Patients who decline to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Matsunaga |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513346
m_matsunaga@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Matsunaga |
Organization
Department of Otolaryngology, Head and Neck Surgery
Division name
Graduate School of Medicine, Kyoto University
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513346
Homepage URL
m_matsunaga@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Mami Matsunaga
Funding Source
Organization
Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-751-4937
070rinririeki@mail2.adm.kyoto-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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 05 | 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 | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted at the Japanese Red Cross Wakayama Medical Center, Kyoto University, and affiliated hospitals of Kyoto University (including Kobe City Medical Center General Hospital, Hyogo Prefectural Amagasaki General Medical Center, Osaka Red Cross Hospital, Tenri Hospital, Kurashiki Central Hospital, Shizuoka General Hospital, and Ako City Hospital).
Patients with postoperative recurrent ECRS who are currently receiving or have newly initiated mepolizumab treatment and who have completed 24 weeks of continuous administration will be included in the analysis.
Patients who were already receiving mepolizumab before this study will be included only if all required data for this analysis are available.
Patients with prior dupilumab treatment before mepolizumab initiation will also be included in the analysis.
Management information
Registered date
| 2025 | Year | 11 | Month | 09 | Day |
Last modified on
| 2025 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068288
