Actively Recruiting
A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps
Led by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-09-19
30
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged between 18 and 75 years, inclusive, of either sex.
- Body Mass Index (BMI) of at least 18.5.
- Diagnosis of chronic rhinosinusitis according to Chinese guidelines, with disease lasting more than 12 weeks.
- Nasal endoscopy showing bilateral nasal mucosa changes or CT scan showing bilateral sinus involvement.
- CT scan with bilateral sinus involvement scoring �3E= 1 on the Lund-MacKay scale in at least one sinus on each side.
- Nasal Congestion Score (NCS) of at least 2 during screening.
- Composite Symptom Score (CSS) for nasal congestion, rhinorrhea, and facial pain/pressure of at least 5 during screening.
- Sino-Nasal Outcome Test-22 (SNOT-22) total score of at least 20 during screening.
- Stable daily dose of mometasone furoate nasal spray for at least 4 weeks prior to enrollment.
- Stable asthma or COPD conditions for 3 months prior if applicable, with stable inhaled corticosteroid use.
- Ability to understand the trial and provide informed consent or have a legal representative do so.
You will not qualify if you...
- Presence or history of nasal polyps.
- Need for systemic corticosteroids as maintenance therapy during screening.
- Diagnosis of cystic fibrosis or primary ciliary dyskinesia.
- Nasal surgery within 4 weeks prior to screening or planned sinus surgery during the study.
- Significant craniofacial abnormalities or severe nasal septal deviation.
- Suspected or confirmed invasive fungal rhinosinusitis, odontogenic sinusitis, osteoma, or nasal tumor.
- Diseases interfering with efficacy assessments, including seasonal allergic rhinitis during treatment, moderate to severe atopic dermatitis requiring certain treatments, or acute upper respiratory infections affecting symptoms.
- Acute infection needing antibiotics within 4 weeks prior.
- Inflammatory or autoimmune diseases requiring systemic biologic or immunosuppressive therapy.
- Allergy or intolerance to study drug components or background therapy.
- Past or current periodontitis or palmoplantar keratoderma related to DPP1 deficiency, or current gingivitis/periodontitis or history of related skin conditions.
- Use of drugs causing skin hyperkeratosis within 4 weeks prior.
- Use of strong CYP3A4 or CYP2D6 inhibitors or inducers within 14 days before first dose.
- Elevated liver function tests requiring treatment.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis during screening.
- Current smokers or inability to abstain during trial.
- Participation in other drug or device trials within 3 months or current enrollment elsewhere.
- Males planning sperm donation or fathering without effective contraceptive use.
- Females planning oocyte donation or pregnancy without effective contraceptive use.
- Pregnant or breastfeeding women.
- Any other reason deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Luoyang First People's Hospital
Luoyang, Henan, China
Actively Recruiting
Research Team
Y
Yanfang Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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