Non-Allergic Rhinitis With Eosinophilia SyndromeESSNARESNCT07240376
Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome
A study testing Stapokibart (CM310) in people with Non-Allergic Rhinitis With Eosinophilia Syndrome, run by Huazhong University of Science and Technology at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Allergic Rhinitis With Eosinophilia Syndrome
- What is being tested?
- Stapokibart (CM310)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 11 sitesChina
- Study dates
- 25 Nov 2025to 28 Feb 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for participation in this clinical trial.
- 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.
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- 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).
Who cannot join
- Subjects who meet any of the following criteria are not eligible to participate in this clinical trial.
- 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.
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- 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.
- Ocular disease at screening (Visit 1): presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections.
- 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.
- 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.
- 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.
- 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 sinusitis, symptoms/signs of chronic purulent postnasal drip, rhinitis medicamentosa, nasal polyps, vasomotor rhinitis, other clinically significant respiratory tract deformities/nasal structural abnormalities, significant nasal trauma (e.g., penetrating injury), or significant nasal septum deviation; any nasal mucosal erosion, nasal septum ulcer, or perforation at screening or prior to randomization; recent nasal piercing not fully healed that may cause nasal symptoms, or planned new nasal piercing during the study.
- Restricted medication use prior to run-in period: use of the following medications and/or treatments within a specified time prior to the run-in period or within 5 half-lives of the drug: IL-4Rα antagonists (within 10 weeks or 5 half-lives), vasoconstrictors (3 days), strong sedatives (3 days), antihistamines (10 days), decongestants (3 days), leukotriene receptor antagonists (7 days), anticholinergics (7 days), cromolyn-like drugs (14 days), systemic antibiotics (14 days), ocular mast cell stabilizers (14 days), monoamine oxidase inhibitors (14 days), tricyclic antidepressants (14 days), strong CYP3A4 inducers/inhibitors (14 days), anti-allergy Chinese herbal medicines (14 days), short- or medium-acting systemic corticosteroids (4 weeks), long-acting systemic corticosteroids (6 weeks), immunotherapy such as desensitization therapy and other biologic monoclonal antibody therapies (3 months), etc.
- Immunosuppression: treatment with biologics/systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis) within 8 weeks prior to randomization or within 5 half-lives (whichever is longer); known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) even if resolved; or abnormally frequent, recurrent, or prolonged infections as judged by the investigator.
- Restricted medication use during the trial: planned use during the trial of the following drugs and/or treatments: a. strong CYP3A4 inducers/inhibitors; b. chronic or intermittent use of corticosteroids (except investigational product); c. antihistamines; d. leukotriene receptor antagonists; e. mast cell membrane stabilizers; f. systemic or intranasal decongestants; g. anticholinergics; h. immunosuppressants; i. anti-allergy Chinese herbal medicines/proprietary Chinese medicines/health products; j. anti-IgE antibodies (e.g., omalizumab for injection); k. nasal irrigations (including saline).
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
- Presence of any other medical or psychological condition that, in the investigator's opinion, may indicate a new and/or insufficiently understood disease, participation in this clinical study may pose an unreasonable risk to the subject, may make the subject unable to participate stably in the study, or may interfere with study evaluations.
- Geographical restrictions: planned long-term travel away from the place of residence for ≥4 consecutive weeks during the trial, or planned residence in an area with a significantly different climate from the long-term place of residence.
- Previous participation in a CM310 clinical trial.
- Previous use of any anti-IL-4Rα monoclonal antibody (e.g., dupilumab) with inadequate treatment response (e.g., treatment failure or intolerance).
- Presence of other uncontrolled severe diseases or recurrent chronic comorbidities, including but not limited to active infection, cardiovascular and cerebrovascular diseases, tuberculosis or other pathogen infections, diabetes, autoimmune diseases, human immunodeficiency virus (HIV) infection, Treponema pallidum infection, active hepatitis B or C, or parasitic diseases.
- History of malignancy within 5 years prior to screening.
- Any other medical or non-medical condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites
Beijing Tsinghua Changgung Hospital
Beijing, 102218
Pingping Cao, +8618327248170, caoping2009@hotmail.com
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Feng Liu, +86 18980606340, 396173028@qq.com
Clifford Hospital
Guangzhou, Guangdong, 510000
Jiangbo Shi, +86138 0888 4437, tsjbent@163.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jing Ye, +8613979161109, yjholly@qq.com
Eye & Ent Hospital of Fudan University
Shanghai, 200030
Hongfei Lou, +86152 1029 5496, louhongfei@yahoo.com
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000
Yu Xu, Doctor, +8615927088198, xuy@whu.edu.cn
Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Ming Zeng, Doctor, 18627006566, zmsx77@163.com
Yingxing Wu, Doctor
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Zheng Liu, Doctor, +8618607110505, zhengliuent@hotmail.com
Zhiyong Li, Doctor
Hubei Provincial Hospital of Integrated Chinese and Western Medicine
Wuhan, Hubei, 430010
Xiao Zhang, +8617671765028, zhangxiao5281401@163.com
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Bei Guo, +8618627181848, 15516946@qq.com
Xiangyang Central Hospital
Xiangyang, Hubei, 441106
Ying Shen, +8613797605688, yshen460@126.com
About this study
Official title: Efficacy and Safety of Stapokibart (CM310) in Non-Allergic Rhinitis With Eosinophilia Syndrome (ESSNARES): An Investigator-initiated, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed description
The objective of this clinical trial is to evaluate the efficacy of Stapokibart (CM310) in alleviating nasal and ocular symptoms, as well as its safety profile, in adult patients with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) who have shown a suboptimal response to intranasal corticosteroids.
Adult NARES patients with an inadequate response to mometasone furoate nasal spray will be enrolled. While continuing treatment with intranasal mometasone furoate, patients will be randomized to receive either Stapokibart or a placebo. Over the 12-week treatment period and the subsequent 8-week follow-up period, the alleviation of nasal and ocular symptoms, the incidence of adverse events, and the results of safety assessments (such as physical examinations, electrocardiograms, complete blood counts, and blood biochemistry) will be evaluated. The final aim is to assess the efficacy and safety of Stapokibart in treating patients with NARES.
- Being tested
- Stapokibart (CM310), Placebo
- Keywords
- Stapokibart, Non-Allergic Rhinitis with Eosinophilia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapokibart (CM310)Biological
Paticipants were given CM310 (with an initial dose of 600 mg followed by 300mg subcutaneous injection, once every two weeks) for 12 weeks. Follow up for another 8 weeks.During the treatment period, mometasone furoate was sprayed nasal every day
PlaceboOther
After enrollment, paticipants were given a placebo (subcutaneous injection, with the same dose as the experimental group, once every two weeks) for 12 weeks. Follow up for another 8 weeks. During the treatment period, mometasone furoate was sprayed nasal every day
| Study group | Role | What they receive |
|---|---|---|
| CM310 group | Experimental | After enrollment, paticipants were given CM310 (with an initial dose of 600 mg followed by 300mg subcutaneous injection, once every two weeks) for 12 weeks. Follow up for another 8 weeks.Mometasone furoate was nasal sprayed daily during treatment Receives: Biological: Stapokibart (CM310) |
| Placebo group | Placebo comparator | After enrollment, paticipants were given a placebo (subcutaneous injection, with the same dose as the experimental group, once every two weeks) for 12 weeks. Follow up for another 8 weeks. During the treatment period, mometasone furoate was sprayed nasal every day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change from baseline in the Reflective Total Nasal Symptom Score (rTNSS) at Week 12.
The Reflective Total Nasal Symptom Score （rTNSS） assesses the severity of nasal symptoms over the past 12 hours and is evaluated in the morning (ante meridiem rTNSS, AMrTNSS) and evening (post meridiem rTNSS, PMrTNSS). The daily rTNSS is the average of AMrTNSS and PMrTNSS. rTNSS isa scoring scale ranging from 0 to 12, with higher scores indicating more severe symptoms.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (9)
reflective Total Nasal Symptom Scores
Mean change from baseline in daily morning AM reflective Total Nasal Symptom Scores (AMrTNSS) during the treatment period; Mean change from baseline in daily evening PM reflective Total Nasal Symptom Scores (PMrTNSS) during the treatment period; rTNSS is the mean of AMrTNSS and PMrTNSS. The rTNSS, AMrTNSS, PMrTNSS are scoring scales ranging from 0 to 12, with higher scores indicating more severe symptoms
Measured: From enrollment to the end of study at 20 weeks
Instant Total Nasal Symptom Score (iTNSS)
Mean change from baseline in the Instant Total Nasal Symptom Score (iTNSS) immediately prior to dosing during the treatment period; The iTNSS is a scoring scale ranging from 0 to 12, with higher scores indicating more severe symptoms
Measured: From enrollment to the end of study at 20 weeks
reflective individual nasal symptom scores
Mean change from baseline in daily reflective individual nasal symptom scores (rhinorrhea, nasal congestion, nasal itching, sneezing) during the treatment period. Daily reflective individual nasal symptom scores are the means of daily daytime (AM) reflective individual nasal symptom scores and daily nighttime (PM) reflective individual nasal symptom scores.
Each symptom score is a scale ranging from 0 to 3, with higher scores indicating more severe symptoms
Measured: From enrollment to the end of study at 20 weeks
Reflective Total Ocular Symptom Score
Mean change from baseline in the daily morning ante meridiem rTOSS (AMrTOSS) during the treatment period should be recorded; and mean change from baseline in the daily evening post meridiem rTOSS (PMrTOSS) during the treatment period should be recored; Mean change from baseline in the daily Reflective Total Ocular Symptom Score (rTOSS) during the treatment period should be calculated. Daily rTOSS is the mean of AMrTOSS and daily PMrTOSS.
The rTOSS, AMrTOSS, PMrTOSS are scoring scales ranging from 0 to 9, with higher scores indicating more severe symptoms
Measured: From enrollment to the end of study at 20 weeks
Instant Total Ocular Symptom Score (iTOSS)
Mean change from baseline in the Instant Total Ocular Symptom Score (iTOSS) immediately prior to dosing during the treatment period.
The rTOSS is a scoring scale ranging from 0 to 9, with higher scores indicating more severe symptoms
Measured: From enrollment to the end of study at 20 weeks
reflective individual ocular symptom scores
Mean change from baseline in daily reflective individual ocular symptom scores (ocular itching, tearing, eye redness) during the treatment period.
Daily reflective individual ocular symptom scores are means of daytime (AM) reflective individual ocular symptom scores and nighttime (PM) reflective individual ocular symptom scores.
Each of reflective individual ocular symptom score is a scale ranging from 0 to 3, with higher scores indicating more severe symptoms.
Measured: From enrollment to the end of study at 20 weeks
Assessment of patient quality of life using the Rhino-Conjunctivitis Quality of Life Questionnaire (RQLQ)
Assessment of patient quality of life using the Rhino-Conjunctivitis Quality of Life Questionnaire (RQLQ), including domains such as daily activities, sleep disturbance, practical problems, nasal symptoms, ocular symptoms, and emotional function, with calculation of the total score.
The RQLQ is a scoring scale ranging from 0 to 168, with higher scores indicating a greater impact of symptoms on daily life.
Measured: From enrollment to the end of study at 20 weeks
visual analogue scale of olfactory function
Evaluation of olfactory function using the visual analogue scale (VAS).The VAS is a scoring scale ranging from 0 to 10, with higher scores indicating more severe symptoms.
Measured: From enrollment to the end of treatment at 12 weeks
Overall evaluation of treatment response
Overall evaluation of treatment response based on a 7-point categorical scale, where subjects rate the change in NARES symptoms at the end of the study as follows: significantly improved, moderately improved, mildly improved, no change, mildly worsened, moderately worsened, or significantly worsened.
Measured: From enrollment to the end of the study at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start25 Nov 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Allergic Rhinitis With Eosinophilia SyndromeStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Wuhan TongJi Hospital
- Responsible party
- Principal investigator, Zheng Liu, Zhongnan Hospital
- Investigators
- Zheng Liu, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240376
- Sponsor's protocol ID
- CM310-NARES
- Acronym
- ESSNARES
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Stapokibart (CM310) in Non-Allergic Rhinitis With Eosinophilia Syndrome (ESSNARES): An Investigator-initiated, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07240376
- Acronym / sponsor ID
- ESSNARES / CM310-NARES
- Keywords
- Stapokibart, Non-Allergic Rhinitis with Eosinophilia Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Wuhan TongJi Hospital
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this clinical trial is to evaluate the efficacy of Stapokibart (CM310) in alleviating nasal and ocular symptoms, as well as its safety profile, in adult patients with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) who have shown a suboptimal response to intranasal corticosteroids.
Adult NARES patients with an inadequate response to mometasone furoate nasal spray will be enrolled. While continuing treatment with intranasal mometasone furoate, patients will be randomized to receive either Stapokibart or a placebo. Over the 12-week treatment period and the subsequent 8-week follow-up period, the alleviation of nasal and ocular symptoms, the incidence of adverse events, and the results of safety assessments (such as physical examinations, electrocardiograms, complete blood counts, and blood biochemistry) will be evaluated. The final aim is to assess the efficacy and safety of Stapokibart in treating patients with NARES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM310 group | Experimental | Biological: Stapokibart (CM310)After enrollment, paticipants were given CM310 (with an initial dose of 600 mg followed by 300mg subcutaneous injection, once every two weeks) for 12 weeks. Follow up for another 8 weeks.Mometasone furoate was nasal sprayed daily during treatment |
| Placebo group | Placebo comparator | Other: PlaceboAfter enrollment, paticipants were given a placebo (subcutaneous injection, with the same dose as the experimental group, once every two weeks) for 12 weeks. Follow up for another 8 weeks. During the treatment period, mometasone furoate was sprayed nasal every day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must meet all of the following criteria to be eligible for participation in this clinical trial.
Key exclusion criteria (25 listed)
- Subjects who meet any of the following criteria are not eligible to participate in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapokibart (CM310)Paticipants were given CM310 (with an initial dose of 600 mg followed by 300mg subcutaneous injection, once every two weeks) for 12 weeks. Follow up for another 8 weeks.During the treatment period, mometasone furoate was sprayed nasal every day | Biological | CM310 group |
| PlaceboAfter enrollment, paticipants were given a placebo (subcutaneous injection, with the same dose as the experimental group, once every two weeks) for 12 weeks. Follow up for another 8 weeks. During the treatment period, mometasone furoate was sprayed nasal every day | Other | Placebo group |
Primary outcome
The mean change from baseline in the Reflective Total Nasal Symptom Score (rTNSS) at Week 12.
Time frame: From enrollment to the end of treatment at 12 weeks
The Reflective Total Nasal Symptom Score （rTNSS） assesses the severity of nasal symptoms over the past 12 hours and is evaluated in the morning (ante meridiem rTNSS, AMrTNSS) and evening (post meridiem rTNSS, PMrTNSS). The daily rTNSS is the average of AMrTNSS and PMrTNSS. rTNSS isa scoring scale ranging from 0 to 12, with higher scores indicating more severe symptoms.
9 secondary outcomes
reflective Total Nasal Symptom Scores
Time frame: From enrollment to the end of study at 20 weeks
Instant Total Nasal Symptom Score (iTNSS)
Time frame: From enrollment to the end of study at 20 weeks
reflective individual nasal symptom scores
Time frame: From enrollment to the end of study at 20 weeks
Reflective Total Ocular Symptom Score
Time frame: From enrollment to the end of study at 20 weeks
Instant Total Ocular Symptom Score (iTOSS)
Time frame: From enrollment to the end of study at 20 weeks
reflective individual ocular symptom scores
Time frame: From enrollment to the end of study at 20 weeks
Assessment of patient quality of life using the Rhino-Conjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: From enrollment to the end of study at 20 weeks
visual analogue scale of olfactory function
Time frame: From enrollment to the end of treatment at 12 weeks
Overall evaluation of treatment response
Time frame: From enrollment to the end of the study at 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zheng Liu principal investigator
Zhongnan Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapokibart (CM310) in people with Non-Allergic Rhinitis With Eosinophilia Syndrome, run by Huazhong University of Science and Technology at 11 sites 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 9 inclusion and 25 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: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yingxing Wu, Doctor (+8613429856579, yingxing1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change from baseline in the Reflective Total Nasal Symptom Score (rTNSS) at Week 12. (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.