UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062430 |
|---|---|
| Receipt number | R000071449 |
| Scientific Title | Elucidation of epithelial immune remodeling and the mechanisms of Tezepelumab-induced restoration in chronic rhinosinusitis with nasal polyps |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/31 18:17:44 |
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Basic information
Public title
Epithelial immune remodeling underlies CRSwNP pathophysiology and tezepelumab restores epithelial function
Acronym
Epithelial immune remodeling and tezepelumab in CRSwNP
Scientific Title
Elucidation of epithelial immune remodeling and the mechanisms of Tezepelumab-induced restoration in chronic rhinosinusitis with nasal polyps
Scientific Title:Acronym
Tezepelumab-induced epithelial immune restoration in CRSwNP
Region
| Japan |
Condition
Condition
Chronic rhinosinusitis with nasal polyps
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. To determine whether tezepelumab restores epithelial homeostasis and normalizes epithelial immune remodeling in patients with CRSwNP.
2. To clarify the pathogenic role of TSLP in olfactory function recovery following tezepelumab treatment.
3. To identify molecular biomarkers predictive of responsiveness to tezepelumab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transcriptomic changes before and after tezepelumab treatment.
Key secondary outcomes
Secondary Endpoints
1. Transcriptomic changes before and after treatment with tezepelumab, assessed separately for respiratory epithelium-associated and olfactory epithelium-associated transcriptomic profiles.
2. Changes from baseline in nasal polyp score and olfactory function tests.
Exploratory Endpoints
1. Differences in respiratory epithelial-associated and olfactory epithelial-associated molecules compared with non-CRS patients.
2. Transcriptomic alterations in respiratory epithelial cells and immune cells assessed by single-cell RNA sequencing (scRNA-seq).
3. Protein expression levels (proteomic analysis) and lipid metabolite profiles (metabolomic analysis) of genes identified as differentially expressed at the transcriptomic level.
4. Explore candidate biomarkers predictive of responsiveness to tezepelumab treatment based on comparative analyses of clinical outcomes, including complete resolution of nasal polyps (nasal polyp score [NPS] <= 0) and improvement in olfactory function (T&T olfactometry recognition threshold <= 2.0).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The use of additional systemic corticosteroids and antibiotics will be restricted to the minimum clinically necessary to avoid potential effects on immunological assessments, and all such use will be documented in tezepelumab-treated group.
Interventions/Control_2
The use of additional systemic corticosteroids and antibiotics will be restricted to the minimum clinically necessary to avoid potential effects on immunological assessments, and all such use will be documented in tezepelumab-untreated chronic rhinosinusitis group.
Interventions/Control_3
The use of additional systemic corticosteroids and antibiotics will be restricted to the minimum clinically necessary to avoid potential effects on immunological assessments, and all such use will be documented in tezepelumab-untreated non-chronic rhinosinusitis group.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To compare clinical and molecular changes before and after tezepelumab treatment under routine clinical practice, three study groups will be defined based on medical records: (1) a tezepelumab-treated CRSwNP group, (2) a tezepelumab-untreated chronic rhinosinusitis (CRS) group, and (3) a tezepelumab-untreated non-CRS control group.
Tezepelumab-Treated Group
1. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
2. Previous surgery for CRSwNP, or, if surgery is contraindicated, at least one of the following:
Inadequate response to systemic corticosteroids within the previous 12 months;
Contraindication to systemic corticosteroids; or
Intolerance to systemic corticosteroids.
3. Persistent disease despite standard treatment, including:
Bilateral nasal polyp score (NPS) >=5 with >=2 in each nasal cavity;
Nasal congestion score >=2 for >4 weeks; and
Rhinorrhea and/or reduced or lost sense of smell for >8 weeks.
4. First initiation of tezepelumab within 10 years after the most recent surgery.
Tezepelumab-Untreated CRS Group
Patients aged >=18 years who underwent surgery for CRS.
Tezepelumab-Untreated Non-CRS Group
Patients aged >=18 years who underwent surgery during the same period for sinonasal tumors, skull base tumors, orbital blowout fractures, concha bullosa, or nasal septal deviation.
Key exclusion criteria
1.Patients who do not meet the above disease criteria; patients with immunodeficiency, pregnancy, or cystic fibrosis; and patients under 18 years of age.
2.Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the enrollment. Chronic maintenance prednisone for the treatment of asthma is allowed.
3.Clinically significant asthma exacerbation, in the opinion of the Investigator, including those requiring use of oral corticosteroids, or an increase in maintenance dose of oral corticosteroids 14 days prior to the enrollment.
4.Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to the enrollment whichever is longer.
5.Patients who are minors or have conditions such as dementia, or whom the attending investigator judges to have difficulty understanding the study and making decisions based on their own free will.
6.Patients for whom participation in the study is considered likely to result in clinical disadvantage or harm.
7.Any other patients deemed inappropriate for participation in the study by the attending investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsuguhisa |
| Middle name | |
| Last name | Nakayama |
Organization
Dokkyo Medical University
Division name
Department of Otorhinolaryngology and Head & Neck Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
t-nakayama855@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Tsuguhisa |
| Middle name | |
| Last name | Nakayama |
Organization
Dokkyo Medical University
Division name
Department of Otorhinolaryngology and Head & Neck Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL
0292-86-1111
Homepage URL
t-nakayama855@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca 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
Dokkyo Medical University Research Management Center
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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 | 07 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | 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
Management information
Registered date
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071449
