Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062430) titled 'Epithelial immune remodeling underlies CRSwNP pathophysiology and tezepelumab restores epithelial function' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Dokkyo Medical University

Condition: Condition - Chronic rhinosinusitis with nasal polyps Classification by malignancy - Others Genomic information - YES

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 years-old =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 Size - 90

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071449

Disclaimer: Curated by HT Syndication.