Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome (NCT07240376) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome
China90 participantsStarted 2025-11-25
Plain-language summary
The goal of this clinical trial is to learn if Stapokibart (CM310) works to treat Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) in adults. It will also learn about the safety of CM310.
The main questions it aims to answer are:
Does drug CM310 relieve the symptoms of participants? What medical problems do participants have when injecting CM310? Researchers will compare CM310 to a placebo (a look-alike substance that contains no drug) to see if CM310 works to treat NARES.
Participants will:
Inject CM310 or a placebo every 2 weeks for 12 weeks, and follow up for another 8 weeks.
Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms every day.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Aged ≥18 and ≤65 years, regardless of gender.
✓. 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.
✓. Laboratory evidence: negative serum Specific Immunoglobulin E (sIgE) and negative Skin Prick Test (SPT); nasal secretion eosinophil proportion \>20% (after excluding epithelial cells).
✓. 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.
✓. 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).
What they're measuring
1
The mean change from baseline in the Reflective Total Nasal Symptom Score (rTNSS) at Week 12.
Timeframe: From enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT07240376
SponsorHuazhong University of Science and Technology
✓. 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.
✓. 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
✕. History of allergy to study drugs: hypersensitivity or intolerance to mometasone furoate, loratadine, CM310 injection, or any component of the placebo.
✕. 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.
✕. 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.
✕. 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.
✕. Use of any rescue medication during the screening and run-in periods.
✕. Nasal procedure history at screening (Visit 1): nasal sinus surgery within 1 year prior to screening or presence of unhealed nasal trauma.
✕. 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.
✕. 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.