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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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).
. 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.