Non-Allergic Rhinitis with Eosinophilia Syndrome
Conditions
Interventions
Placebo group:CM310 Injection Placebo
Experimental group:CM310 Injection
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subject must understand the investigational nature of this study and must provide written informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to undergoing any study-related procedures. 2. Aged =18 and =65 years, regardless of gender. 3. Diagnosed with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) according to the following criteria: chronic course lasting =2 years, with intermittent nasal symptoms including alternating nasal congestion, watery rhinorrhea, paroxysmal sneezing, nasal itching, postnasal drip, and hyposmia; with evidence against allergic rhinitis. 4. Laboratory evidence: negative serum Specific Immunoglobulin E (sIgE) and negative Skin Prick Test (SPT); nasal secretion eosinophil proportion >20% (after excluding epithelial cells). 5. The subject's history prior to the screening period indicates inadequate control of NARES symptoms (with an iTNSS =4 and at least one of the symptoms - nasal congestion, rhinorrhea, nasal itching, or sneezing - scoring =2) despite the use of intranasal corticosteroids or other medications (e.g., antihistamines, leukotriene receptor antagonists) following symptom onset. 6. At the baseline visit (after run-in treatment), the subject must meet the following criteria: an iTNSS =4, the average of the most recent 6 daily Reflective Total Nasal Symptom Scores (rTNSS) =4, and at least one of the symptoms - nasal congestion, rhinorrhea, nasal itching, or sneezing - scoring =2 in these assessments (i.e., the 3 morning and 3 evening evaluations over the last three 24-hour periods, including the iTNSS assessment at the baseline visit). 7. Willing and able to comply with all visits, study-related procedures, and questionnaires, including adherence to required background medications and completion of a daily electronic diary (eDiary). During the screening/run-in period, subjects must complete at least 80% of the diary assessments. 8. Subjects agree to use highly effective contraception (including vasectomy, abstinence, etc.) throughout the study period (from signing the ICF until 3 months after the last dose of study drug).
Exclusion criteria
Exclusion criteria: 1. History of allergy to study drugs: hypersensitivity or intolerance to mometasone furoate, loratadine, CM310 injection, or any component of the placebo. 2. Laboratory abnormalities: severe hepatic or renal dysfunction, abnormal liver function [Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) >1.5 × Upper Limit of Normal (ULN), or Total Bilirubin (TBIL) >1.5 × ULN with abnormal AST] or abnormal renal function (serum creatinine >1.2 × ULN); clinically significant abnormalities in laboratory blood chemistry or hematology results at screening (Visit 1) or baseline (Visit 2) as judged by the investigator. 3. History of harmful behavior: history of drug abuse, alcohol dependence (average daily alcohol intake >40 g) within 2 years prior to screening, or current drug user. 4. Currently receiving allergen immunotherapy (subcutaneous or sublingual immunotherapy [SCIT/SLIT]). Subjects who discontinued SCIT/SLIT =3 years prior to randomization and are not on a maintenance regimen are eligible. 5. Use of any rescue medication during the screening and run-in periods. 6. Nasal procedure history at screening (Visit 1): nasal sinus surgery within 1 year prior to screening or presence of unhealed nasal trauma. 7. Drug exposure at screening (Visit 1): participation in another drug clinical trial and use of an investigational drug within 3 months prior to screening, or planned use of another investigational drug during the study. 8. Vaccination at screening (Visit 1): receipt of a live attenuated vaccine within 12 weeks prior to screening or planned vaccination with a live attenuated vaccine during the trial. 9. Ocular disease at screening (Visit 1): presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections. 10. Infection history at screening (Visit 1): active or inactive pulmonary tuberculosis infection; untreated localized or systemic fungal, bacterial, viral, or parasitic infection requiring ongoing treatment which, in the investigator’s judgment, may place the subject at undue risk or affect result interpretation (e.g., severe infection requiring hospitalization and/or IV or equivalent oral antibiotics); symptomatic herpes zoster infection not resolved at screening; recurrent infections (including but not limited to recurrent cellulitis, chronic osteomyelitis). Subjects with only recurrent, mild, uncomplicated herpes labialis and/or genital herpes may be enrolled. Subjects with a history of active or latent tuberculosis with written evidence of adequate treatment, no history of re-exposure since completion of treatment, and no evidence of active tuberculosis on chest X-ray at screening may be enrolled. 11. Subjects with comorbid asthma (including suspected asthma) are excluded if they meet any of the following: FEV1 =60% of predicted; or an asthma exacerbation within 3 months prior to screening requiring systemic corticosteroids or hospitalization (>24 hours); or required inhaled corticosteroid dosage >1000 µg fluticasone propionate or equivalent. 12. Known history of recurrent acute or chronic rhinosinusitis, defined as requiring systemic antibiotic treatment within 3 months prior to screening, or >4 recurrences within 2 years prior to screening. 13. Conditions affecting drug deposition: nasal disease or symptoms/signs identified during screening or prior to randomization that, in the investigator’s judgment, may affect intranasal drug deposition, such as acute or chronic sinu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in the daily Reflective Total Nasal Symptom Score (rTNSS) at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination;Safety Laboratory Tests;Rhino-Conjunctivitis Quality of Life Questionnaire (RQLQ);Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment and Follow-up Periods;12-Lead Electrocardiogram (ECG);Olfactory Assessment;Area Under the Curve (AUC) for the Change from Baseline in Daily rTNSS During the Treatment Period;Overall Evaluation of Treatment Response;Mean Change from Baseline in the Instant Total Nasal Symptom Score (iTNSS) Prior to Dosing During the Treatment Period;Total Ocular Symptom Score (TOSS) During the Treatment Period;Mean Change from Baseline in the Instant Total Ocular Symptom Score (iTOSS) Prior to Dosing During the Treatment Period;Total Nasal Symptom Score (TNSS) During the Treatment Period;Number of Days with No or Mild Symptoms During the Treatment Period; | — |
Countries
China
Contacts
Public ContactZheng Liu
Zhongnan Hospital of Wuhan University
Outcome results
None listed