A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhino… (NCT07174115) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps
China30 participantsStarted 2025-08-18
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. During the screening period, a CT scan must demonstrate bilateral sinus involvement, with at least one sinus on each side scoring ≥ 1 point on the Lund-MacKay (LMK) scale.
✓. During the screening period, the Nasal Congestion Score (NCS) must be ≥ 2 points.
✓. During the screening period, the Composite Symptom Score (CSS) for nasal congestion, rhinorrhea, and facial pain/pressure must be ≥ 5 points.
✓. During the screening period, the Sino-Nasal Outcome Test-22 (SNOT-22) total score must be ≥ 20 points.
Exclusion criteria
✕. 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.
What they're measuring
1
Change from baseline in Lund-MacKay (LMK) score on sinus CT scan at Week 12
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT07174115
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.
. 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.
✕. Presence of significant craniofacial structural abnormalities or severe nasal septal deviation.
✕. Radiological suspicion or confirmed diagnosis of invasive fungal rhinosinusitis, odontogenic sinusitis, osteoma, or nasal tumor.
✕. Presence of a disease or comorbidity that would interfere with the assessment of the primary efficacy endpoints (e.g., subjects with seasonal allergic rhinitis whose symptoms coincide with the study treatment period; subjects with moderate to severe atopic dermatitis requiring treatment with potent topical corticosteroids, topical calcineurin inhibitors, or biologics; subjects with acute upper respiratory tract infection that, in the investigator's judgment, would affect nasal symptom scoring).
✕. Presence of an acute infection requiring antibiotic treatment within 4 weeks prior to screening.