The purpose of this clinical trial is to assess the efficacy and safety of HTMC0658 tablets in treating subjects with chronic rhinosinusitis without nasal polyps (CRSsNP).
Subjects aged between 18 and 75 years, inclusive, of either sex.
Body Mass Index (BMI) calculated as weight in kilograms divided by the square of height in meters (kg/m²), with a BMI of at least 18.5.
Subjects must meet the diagnostic criteria for chronic rhinosinusitis as defined in the "Chinese Chronic Rhinosinusitis Diagnosis and Treatment Guidelines (2024)," with a disease duration exceeding 12 weeks.
During the screening period, nasal endoscopy must reveal bilateral pathological changes in the nasal mucosa, such as edema and purulent discharge, or a CT scan must show bilateral sinus involvement.
Presence of nasal polyps confirmed by nasal endoscopy during the screening period, or a history of nasal polyps.
Requirement for systemic corticosteroids as maintenance therapy during the screening period.
Diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia.
Undergone nasal surgery within 4 weeks prior to screening, or scheduled for sinus surgery during the study period.
Single group
HTMC0658
DrugHTMC0658 tablet
Change from baseline in Lund-MacKay (LMK) score on sinus CT scan at Week 12
Lund-MacKay (LMK) score for CT scan of the sinuses: This score evaluates the left and right maxillary sinuses, anterior ethmoid sinuses, posterior ethmoid sinuses, sphenoid sinuses, frontal sinuses, and the ostiomeatal complex. Scoring criteria are as follows: For the sinuses: 0 = no abnormality, 1 = partially opacified, 2 = completely opacified; For the ostiomeatal complex: 0 = no obstruction, 2 = obstruction. The score for each side ranges from 0 to 12, with a total possible score of 0 to 24.
Change from baseline in Composite Symptom Score (CSS) at Weeks 4, 8, and 12
Composite Symptom Score (CSS) for Chronic Rhinosinusitis: These symptoms are categorized into three types: nasal congestion, facial pain/pressure, and nasal discharge. The scoring criteria are as follows: 0 = no symptoms (absence of noticeable signs or symptoms), 1 = mild symptoms (presence of signs or symptoms that are mild and tolerable), 2 = moderate symptoms (signs or symptoms that are noticeable and uncomfortable but tolerable), 3 = severe symptoms (signs or symptoms that are intolerable and interfere with daily activities and/or sleep). The total score ranges from 0 to 9.
Change from baseline in the Sino-Nasal Outcome Test-22 (SNOT-22) scale score at Weeks 4, 8, and 12
The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, extra-nasal rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be, and total scores are calculated by adding scores together.
Change from baseline in the Visual Analog Scale (VAS) score for the severity of rhinosinusitis at Weeks 4, 8, and 12
Visual Analogue Scale (VAS) for the Severity of Chronic Rhinosinusitis: Draw a 10 cm straight line on a piece of white paper. Label one end as "No Disturbance" and the other end as "The Worst Disturbance That Can Be Imagined" to create the VAS. The subject marks a point on the line corresponding to the severity of their sinusitis symptoms. The distance from the starting point to the marked point represents the quantified severity of the symptoms.
Change from baseline in Nasal Congestion Score (NCS) at Weeks 4, 8, and 12
Nasal Congestion Score: The scoring criteria are as follows: 0 = No symptoms (no obvious signs/symptoms), 1 = Mild symptoms (signs/symptoms exist but are mild and tolerable), 2 = Moderate symptoms (signs/symptoms are obvious, causing discomfort but still tolerable), 3 = Severe symptoms (signs/symptoms are unbearable, affecting daily activities and/or sleep). The total score ranges from 0 to 3.
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