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Chronic Sinusitis Without Nasal PolypsPhase 2NCT07174115

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

A Phase 2 study testing HTMC0658 in people with Chronic Sinusitis Without Nasal Polyps, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Sinusitis Without Nasal Polyps
What is being tested?
HTMC0658
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
18 Aug 2025to Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Subjects must have been on a stable daily dose of mometasone furoate nasal spray (MFNS) for at least 4 weeks prior to enrollment.
  • Subjects 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 corticosteroid use). The use of inhaled corticosteroids must have been at a stable dose, with continuous use for at least 3 months prior to screening, and planned continuation throughout the study period.
  • Subjects 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 representative provide informed consent.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Subjects 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. Subjects with current signs of gingivitis/periodontitis.b. Subjects with a history of palmoplantar keratoderma or erythema.
  • 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.
  • Subjects 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 aminotransferase (ALT) > 2.0 × upper limit of normal (ULN), or total bilirubin (TBIL) > 1.5 × ULN.
  • Subjects 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.
  • Subjects 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 subjects 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 subjects 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.
  • Subjects whom the investigator deems unsuitable for participation in this study for any reason.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanfang Feng contact

86-021-64311017

clinical_trial@hllife.com.cn

China1 site, 1 recruiting

  • Luoyang First People's Hospital

    Luoyang, Henan

    Qingyao Yuan, 86-18568123773, 597860973@qq.com

    Qingyao Yuan

    Recruiting

Other trials in China

About this study

Official title: A Phase IIa Clinical Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps

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).

Being tested
HTMC0658
Keywords
chronic sinusitis without nasal polyps, Dipeptidyl peptidase 1, neutrophil-related inflammatory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTMC0658Drug

    Also called YD0293 tablet

    HTMC0658 tablet

Study groups in NCT07174115
Study groupRoleWhat they receive
HTMC0658ExperimentalParticipants will receive HTMC0658 tablet, orally, QD for 12 weeks along with mometasone furoate nasal spray (MFNS) by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.
Receives: Drug: HTMC0658

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 12 weeks

Secondary outcomes (9)

  1. 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.

    Measured: baseline to 4, 8 and 12 weeks

  2. 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.

    Measured: baseline to 4, 8, and 12 weeks

  3. 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.

    Measured: baseline to 4, 8, and 12 weeks

  4. 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.

    Measured: baseline to 4, 8, and 12 weeks

  5. Patient Global Impression of Change (PGIC) scale score at Week 12

    The global impression of change will be assessed using a subject-completed PGIC scale, which ranges from 1 to 7: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse.

    Measured: 12 weeks

  6. Proportion of subjects requiring rescue therapy (antibiotics, systemic corticosteroids, and/or nasal surgery) due to worsening of any chronic rhinosinusitis symptoms within 12 weeks.

    Measured: 12 weeks

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and laboratory test results, etc.

    Measured: baseline to 16 weeks

  8. Plasma Concentration of HTMC0658

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 30

  9. Changes in serum neutrophil elastase (NE) concentration

    Changes from baseline in serum neutrophil elastase (NE) concentration at Weeks 4, 8, and 12 of treatment.

    Measured: Baseline to 4, 8, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start18 Aug 2025
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174115
Sponsor's protocol ID
PY-HTMC0658-IIa-01
Status last verified
Sep 2025
First submitted
8 Sep 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HTMC0658 in people with Chronic Sinusitis Without Nasal Polyps, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanfang Feng (86-021-64311017, clinical_trial@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Lund-MacKay (LMK) score on sinus CT scan at Week 12 (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07174115.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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