A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HTMC0658

Treatment groups

30 Participants
are divided into 1 treatment group