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Tests treatment safety and results for Chronic Sinusitis Without Nasal Polyps
Official title A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps
ClinicalTrials.gov ID: NCT07174115
What this study is testing
What is HTMC0658?
HTMC0658 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic sinusitis without nasal polyps.
Also referred to as YD0293 tablet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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.
- people must meet the diagnostic criteria for chronic rhinosinusitis as defined in the "Chinese Chronic Rhinosinusitis Diagnosis and Treatment...
- During the screening period, nasal endoscopy must reveal bilateral pathological changes in the nasal mucosa, such as edema and purulent discharge, or...
- 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...
You likely can't join if
- 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.
- 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.
See the full eligibility criteria
Who can join
- people 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.
- people 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.
- people must have been on a stable daily dose of mometasone furoate nasal spray (MFNS) for at least 4 weeks prior to enrollment.
- people with asthma or chronic obstructive pulmonary disease (COPD) must have had stable conditions without exacerbations in the 3 months prior to screening (e.g., no emergency room visits, hospitalizations, or systemic...
- people must fully understand the purpose, nature, methodology, and potential adverse events of the trial, voluntarily participate in the trial, and provide written informed consent, or have an authorized legal...
What rules you out
- 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.
- 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 how well it works endpoints (e.g., people with seasonal allergic rhinitis whose symptoms coincide with the study treatment...
- Presence of an acute infection requiring antibiotic treatment within 4 weeks prior to screening.
- Inflammatory or autoimmune diseases requiring systemic biologic therapy or immunosuppressive agents (including but not limited to immunodeficiency diseases).
- Known allergy or intolerance to any component of the investigational medicinal product or background therapy.
- people with a past or current diagnosis of periodontitis or palmoplantar keratoderma due to functional deficiency of dipeptidyl peptidase 1 (DPP1), or the presence of the following at screening:a. people with current...
- Receipt of drugs that may cause skin hyperkeratosis (e.g., tumor necrosis factor-α antagonists) within 4 weeks prior to screening.
- Patients who have used strong CYP3A4 or CYP2D6 inhibitors or inducers within 14 days prior to the first administration of the investigational medicinal product.
- people with elevated liver function test results during the screening period and currently requiring treatment for liver disease. Elevated liver function tests are defined as: aspartate aminotransferase (AST) or alanine...
- people with positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and/or syphilis serology during the screening period.
- Current smokers (defined as adults who have smoked at least 100 cigarettes in their lifetime and are currently smoking) or those who cannot abstain from smoking during the trial.
- people who have participated in other drug or medical device trials within 3 months prior to the start of this trial or are currently enrolled in another clinical trial.
- Male people who plan to donate sperm or have a fathering plan from the start of dosing until 90 days after the last dose and are unwilling to use effective non-pharmacological contraceptive measures.
- Female people who plan to donate oocytes or have a pregnancy plan from the start of dosing until 30 days after the last dose and are unwilling to use effective non-pharmacological contraceptive measures.
- Pregnant or breastfeeding women.
- people whom the investigator deems unsuitable for participation in this study for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Luoyang, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luoyang, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.