Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome

NCT07240376 | Not Yet Recruiting DMC

• 1 other identifier: CM310-NARES
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Non-Allergic Rhinitis With Eosinophilia Syndrome

Keywords

Stapokibart; Non-Allergic Rhinitis with Eosinophilia Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (9)

• reflective Total Nasal Symptom Scores

  From enrollment to the end of study at 20 weeks

• Instant Total Nasal Symptom Score (iTNSS)

  From enrollment to the end of study at 20 weeks

• reflective individual nasal symptom scores

  From enrollment to the end of study at 20 weeks

• Reflective Total Ocular Symptom Score

  From enrollment to the end of study at 20 weeks

• Instant Total Ocular Symptom Score (iTOSS)

  From enrollment to the end of study at 20 weeks

Other Outcomes (13)

• Area Under the Curve (AUC) for the change from baseline in daily rTNSS during the treatment period.

  From enrollment to the end of treatment at 12 weeks

• Number of days with no or mild symptoms during the treatment period.

  From enrollment to the end of treatment at 12 weeks

• Peripheral Blood eosinophil

  At day 1, day 85 and day 141

Study Arms (2)

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

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

Other: Placebo

Interventions

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

CM310 group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Renmin Hospital of Wuhan University: collaborator
• Wuhan TongJi Hospital: collaborator

Study Sites (11)

Clifford Hospital

Guangzhou, Guangdong, 510000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

Tongji hospital, Tongji medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Wuhan, Hubei, 430010, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, 430014, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441106, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

Location

Eye & Ent Hospital of Fudan University

Shanghai, 200030, China

Location

Study Officials

• Zheng Liu

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingxing Wu, Doctor

CONTACT

+8613429856579; yingxing1006@126.com

Ming Zeng, Doctor

CONTACT

+8618627006566; zmsx77@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., FAAAAI Vice President, Chinese Society of Allergy Professor of Otolaryngology-Head & Neck Surgery Party Secretary of Zhongnan Hospital Wuhan University

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 20, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 3 years after the publication of results
• Access Criteria: The study protocol, statistical analysis plan, and study results from this research will be available on ClinicalTrials.gov and in journals where the primary results are published. If additional data is required by other researchers, they may contact the corresponding author to request access to the data after the publication of the primary study findings.

Locations

CN (11)