ChiCTR2500111463 版本V1.0 版本创建时间2025/10/31 15:21:54 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500111463 

最近更新日期：

Date of Last Refreshed on：

2025-10-31 15:21:44 

注册时间：

Date of Registration：

2025-10-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

司普奇拜(CM310)治疗非变应性鼻炎伴嗜酸粒细胞增多综合征的有效性与安全性评价：一项研究者发起的前瞻性、随机、双盲、安慰剂对照临床研究

Public 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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

司普奇拜(CM310)治疗非变应性鼻炎伴嗜酸粒细胞增多综合征的有效性与安全性评价：一项研究者发起的前瞻性、随机、双盲、安慰剂对照临床研究

Scientific 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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

刘争 

研究负责人：

刘争 

Applicant：

Zheng Liu 

Study leader：

Zheng Liu 

申请注册联系人电话：

Applicant telephone：

+86 186 0711 0505

研究负责人电话：

Study leader's telephone：

+86 27 6781 3009

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

zhengliuent@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

zhengliuent@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

湖北省武汉市武昌区东湖路169号

研究负责人通讯地址：

湖北省武汉市武昌区东湖路169号

Applicant address：

No. 169, Donghu Road, Wuchang District, Wuhan City, Hubei Province

Study leader's address：

No. 169, Donghu Road, Wuchang District, Wuhan City, Hubei Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

武汉大学中南医院

Applicant's institution：

Zhongnan Hospital of Wuhan University

研究负责人所在单位：

武汉大学中南医院

Affiliation of the Leader：

Zhongnan Hospital of Wuhan University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

临研伦2025184

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

武汉大学中南医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Zhongnan Hospital of Wuhan University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-17 00:00:00

伦理委员会联系人：

郑磊

Contact Name of the ethic committee：

Zheng Lei

伦理委员会联系地址：

东湖路169号

Contact Address of the ethic committee：

No.169 Donghu Road, Wuchang District, Wuhan, Hubei, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 27 67812787

伦理委员会联系人邮箱：

Contact email of the ethic committee：

znyyll@126.com

研究实施负责（组长）单位：

武汉大学中南医院

Primary sponsor：

Zhongnan Hospital of Wuhan University

研究实施负责（组长）单位地址：

湖北省武汉市武昌区东湖路169号

Primary sponsor's address：

No.169 Donghu Road, Wuchang District, Wuhan, Hubei, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

武汉大学中南医院

具体地址：

湖北省武汉市武昌区东湖路169号

Institution
hospital：

Zhongnan Hospital of Wuhan University

Address：

No.169 Donghu Road, Wuchang District, Wuhan, Hubei, China

经费或物资来源：

重大慢性非传染性疾病防控研究;同济医院高质量临床研究基金

Source(s) of funding：

National Key Research and Development Program of China;High-quality Clinical trail Fund of Tongji Hospital

Target disease：

Non-Allergic Rhinitis with Eosinophilia Syndrome

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的： 评价司普奇拜(CM310)注射液在非变应性鼻炎伴嗜酸粒细胞增多综合征患者(Non-Allergic Rhinitis with Eosinophilia Syndrome，NARES)中的疗效。 次要目的： 评价司普奇拜(CM310)注射液在非NARES患者中的安全性。 探索性目的： 探索司普奇拜(CM310)注射液对NARES患者的生物标志物的改变。  

Objectives of Study：

Main purpose: To evaluate the efficacy of Stapokibart (CM310) injection in patients with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES). Secondary objective To evaluate the safety of Stapokibart (CM310) injection in non-NARES patients. Exploratory purpose To explore the changes in biomarkers of patients with NARES caused by Stapokibart (CM310) injection.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 受试者必须了解本研究的试验性质，且在签署一份经机构审查委员会 (Institutional Review Board, IRB)/独立伦理委员会 (Independent Ethics Committee, IEC) 批准的知情同意书后才能接受任何研究相关程序； 2. 年龄>=18 且<=65 周岁，性别不限； 3. 根据诊断标准诊断为NARES：长期慢性病程，症状持续2年，表现为间断性发作的鼻部症状，包括交替性鼻塞、清水样鼻分泌物、阵发性喷嚏、鼻痒、鼻涕倒流及嗅觉减退，并排除变应性鼻炎证据； 4. 实验室依据：血清特异性IgE（Specific Immunoglobulin E, sIgE）阴性且皮肤点刺试验（Skin prick test, SPT）阴性；鼻分泌物嗜酸性粒细胞比例＞20%（排除上皮细胞后）； 5. 受试者在筛查期前的病史表明，症状发作后使用鼻腔皮质类固醇或其他药物（抗组胺药、白三烯受体拮抗剂等），NARES症状控制不佳（iTNSS评分>=4分，鼻塞、流涕、鼻痒和打喷嚏至少一项≥2分）; 6. 基线访视时（筛选导入期治疗后），iTNSS评分>=4分，最近6次的每日回顾性鼻部症状评分（rTNSS）>=4分，鼻塞、流涕、鼻痒和打喷嚏至少一项>=2分（即最后三个24小时期间的3次晨间评估和3次晚间评估，包括基线访视时的即时TNSS评估）; 7. 愿意并能够依从所有访视、研究相关程序和问卷调查，重要事项包括接受必需的背景药物和填写每日电子日记 (eDiary)，在筛选/导入期期间，受试者必须完成日记卡中至少80%的评估记录； 8. 受试者同意整个研究期间（从签署 ICF 到末次研究药物给药后 3 个月）采取高效避孕措施（包括：输精管结扎术、禁欲等）。

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).

排除标准：

1. 研究药物过敏史：对糠酸莫米松及氯雷他定、CM310注射液或安慰剂成分过敏或不耐受；
2. 实验室检查异常：严重肝肾功能不全，肝功能异常[丙氨酸氨基转移酶（Alanine Aminotransferase, ALT）/天冬氨酸氨基转移酶（Aspartate Transaminase, AST）＞1.5×正常值上限（Upper Limit of Mormal, ULN），或总胆红素（Total Bilirubin, TBIL）＞1.5×ULN伴AST异常]或肾功能异常（血清肌酐＞1.2×ULN），筛选时（访视 1）或基线时（访视 3）存在研究者认为具有临床意义的实验室血生化或血液学检查结果异常。
3. 不良行为史：筛选前2年内有药物滥用、酒精依赖史（日均酒精摄入＞40g）或吸毒者；
4. 目前正在接受过敏原免疫治疗（皮下或舌下免疫治疗 [Subcutaneous Immunotherapy, SCIT/ Sublingual Immunotherapy, SLIT]）。随机分组前已停用 SCIT/SLIT ≥ 3 年且未接受过敏原免疫治疗维持方案的受试者符合入选资格。
5.在筛选期和导入期内，接受过任何补救药物治疗。
6. 筛选（访视 1）鼻部操作史：筛选前1年内接受鼻窦手术或存在未愈合的鼻创伤；
7. 筛选（访视 1）药物暴露：前3个月内参加过其它药物临床试验，且使用研究药物者，或研究期间拟使用其他研究药物者；
8. 筛选（访视 1）疫苗接种：前12周内接种过减毒活疫苗或计划在试验期间接种减毒活疫苗者；
9. 筛选（访视 1）眼部疾病：存在青光眼、白内障、眼部单纯性疱疹、感染性结膜炎或其他眼部感染者；
10. 筛选（访视 1）感染史：存在活动性或非活动性肺部结核感染，未治愈且仍需持续治疗的局部或全身性真菌、细菌、病毒或寄生虫感染，经研究者判断受试者可能会处于不适风险或影响试验结果判断者，例如需要住院治疗和/或静脉注射或等效口服抗生素治疗的严重感染（需要住院治疗和/或静脉注射或等效口服抗生素治疗）；筛选时尚未消退的有症状带状疱疹感染；复发性感染（包括但不限于复发性蜂窝织炎、慢性骨髓炎），仅存在复发性、轻度且无并发症的口唇疱疹和/或生殖器疱疹的受试者入选本研究；有活动性结核或潜伏性结核病史，且有经过适当治疗的书面证据，自上次完成治疗以来无再暴露史，并且胸部 X 线检查筛选显示无活动性结核证据可纳入研究。
11. 合并哮喘（包括疑似诊断哮喘）的受试者如满足以下条件，将被排除：FEV1≤60%的预测值；或筛选前 3 个月内出现哮喘急性发作，需要全身性糖皮质激素治疗或住院（＞24小时）；或吸入性糖皮质激素用量需＞1000μg丙酸氟替卡松或为相当剂量的其他吸入性糖皮质激素；
12. 已知具有复发性急性或慢性鼻窦炎病史，定义为在筛选前 3 个月内需要接受全身性抗生素治疗，或在筛选前 2 年内出现过大于 4 次复发；
13. 影响药物沉积的病变：筛选期或随机前鼻部检查结果经研究者判断存在可能影响鼻内药物沉积的鼻部疾病或症状/体征，例如急性或慢性鼻窦炎、慢性化脓性鼻后滴漏的症状或体征、药物性鼻炎、鼻息肉、血管舒缩性鼻炎、其他具有临床意义的呼吸道畸形/鼻结构异常、显著的鼻创伤（例如鼻贯通伤）或显著的鼻中隔偏曲者；在筛选期或随机前的鼻部检查中，存在任何鼻黏膜糜烂，鼻中隔溃疡或鼻中隔穿孔者；近期接受过鼻穿孔，且尚未完全愈合，可能引起鼻部症状，或者受试者计划在参加研究期间接受新的鼻穿孔；
14. 导入期前药物使用限制：导入期前一定时间内或药物的5个半衰期内使用过以下药物和/或治疗者：接受过IL-4Rα拮抗剂治疗（10周内或5个半衰期内）、血管收缩药（3天）、强镇静药（3天）、抗组胺药（10 天）、减充血剂（3天）、白三烯受体拮抗剂（7天）、抗胆碱药（7 天）、色甘酸类（14天）、全身性抗生素（14天）、眼用肥大细胞稳定剂（14天）、单胺氧化酶抑制剂（14天）、三环类抗抑郁剂（14天）、强效CYP3A4 诱导/抑制剂（14天）、抗过敏中草药（14天）、中短效全身皮质类固醇（4周）、长效全身皮质类固醇（6周）、免疫治疗如脱敏治疗及其他生物制剂单抗治疗（3个月）等；
15. 免疫抑制：在随机分组前的8周内或5个半衰期内（以较长者为准），因炎症性疾病或自身免疫性疾病（如类风湿性关节炎、炎症性肠病、原发性胆汁性胆管炎、系统性红斑狼疮、多发性硬化症等）接受过生物制剂/全身性免疫抑制剂治疗（包括但不限于甲氨蝶呤、环孢素、霉酚酸酯、他克莫司、青霉胺、柳氮磺吡啶、羟氯喹、硫唑嘌呤、环磷酰胺）；有已知或疑似免疫抑制病史，包括侵袭性机会性感染史（例如组织胞浆菌病、李斯特菌病、球孢子菌病、肺孢子虫病、曲霉病），尽管感染已消退；或研究者认为存在异常频繁、反复或长期感染。
16. 试验期间药物使用限制：计划在试验期间使用以下药物或/和治疗者：a.强效 CYP3A4 诱导/抑制剂； b.慢性或间歇性使用糖皮质激素（试验用药品除外）；c.抗组胺药；d.白三烯受体拮抗剂；e.肥大细胞膜稳定剂；f. 全身或鼻内减充血剂；g.抗胆碱药；h.免疫抑制剂；i.抗过敏中草药/中成药/保健品；j.抗 IgE 抗体（如注射用奥马珠单抗）；k.鼻腔冲洗剂（包括盐水）；
17. 女性受试者处于妊娠期、哺乳期，或者计划在研究期间怀孕或哺乳；
18. 存在任何其他医学或心理病症，研究者认为这种病症可能提示一种新的和/或尚未充分了解的疾病，参加本临床研究可能给研究受试者带来不合理的风险，可能使受试者无法稳定参加研究，或可能干扰研究评估；
19. 地理限制：试验期间计划长期到居住地以外地区旅行连续4周及以上者，或计划到和长期居住地气候差异较大的地区居住；
20. 既往参加过CM310临床试验者；
21. 既往使用过任何抗IL-4Rα单抗（如度普利尤单抗）但治疗应答不佳（如治疗失败或受试者不耐受治疗）的患者；
22. 存在其他控制不佳的严重疾病或反复发作的慢性疾病合并症，包括但不限于活动性感染、心脑血管疾病、肺结核或其他病原体感染、糖尿病、自身免疫性疾病、人类免疫缺陷病毒感染、梅毒螺旋体感染、活动性乙型肝炎、丙型肝炎或寄生虫病；
23. 筛选前5年内患恶性肿瘤；
24. 研究者认为受试者存在其他不适合参加本研究的医学或非医学情况。

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 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.
14. 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.
15. 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.
16. 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).
17. Female subjects who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
18. 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.
19. 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.
20. Previous participation in a CM310 clinical trial.
21. Previous use of any anti-IL-4Rα monoclonal antibody (e.g., dupilumab) with inadequate treatment response (e.g., treatment failure or intolerance).
22. 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.
23. History of malignancy within 5 years prior to screening.
24. Any other medical or non-medical condition that, in the investigator’s opinion, makes the subject unsuitable for participation in this study;

研究实施时间：

Study execute time：

从 From 2025-09-23 00:00:00至 To 2027-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-10-31 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

45

Group：

Placebo group

Sample size：

干预措施：

CM310注射液安慰剂

干预措施代码：

Intervention：

CM310 Injection Placebo

Intervention code：

组别：

试验组

样本量：

45

Group：

Experimental group

Sample size：

干预措施：

CM310注射液

干预措施代码：

Intervention：

CM310 Injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

武汉大学中南医院 

单位级别：

三级甲等 

Institution
hospital：

Zhongnan Hospital of Wuhan University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

武汉市中心医院 

单位级别：

三级甲等 

Institution
hospital：

The Central Hospital of Wuhan

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川大学华西医院 

单位级别：

三级甲等 

Institution
hospital：

West China Hospital of Sichuan University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

广东祈福医院 

单位级别：

三级甲等 

Institution
hospital：

Guangdong Clifford Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京清华长庚医院 

单位级别：

三级医院 

Institution
hospital：

Beijing Tsinghua Changgung Hospital

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 江西省 

市(区县)：

  

Country：

China 

Province：

Jiangxi 

City：

 

单位(医院)：

南昌大学第一附属医院 

单位级别：

三级甲等 

Institution
hospital：

The first affiliated hostipal of nanchang university

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

武汉大学人民医院 

单位级别：

三级甲等 

Institution
hospital：

Renmin Hospital of Wuhan University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

复旦大学附属眼耳鼻喉科医院 

单位级别：

三级甲等 

Institution
hospital：

Eye & ENT hospital of Fudan University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

华中科技大学同济医学院附属同济医院 

单位级别：

三级甲等 

Institution
hospital：

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

湖北省中西医结合医院 

单位级别：

三级甲等 

Institution
hospital：

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

体格检查

指标类型：

次要指标

Outcome：

Physical Examination

Type：

Secondary indicator

测量时间点：

访视1到访视10

测量方法：

进行包括生命体征在内的鼻部，眼部，面部以及全身各个系统的体格检查

Measure time point of outcome：

Visits 1 to Visit 10

Measure method：

Examinations will include the nasal cavity, eyes, face, and all other body systems, including vital signs.

指标中文名：

安全性实验室检查

指标类型：

次要指标

Outcome：

Safety Laboratory Tests

Type：

Secondary indicator

测量时间点：

访视1，访视2，访视4，访视6，访视8，访视9和访视10

测量方法：

检测患者血常规，血生化，尿常规

Measure time point of outcome：

At Visits 1, 2, 4, 6, 8, 9, and 10

Measure method：

Tests will include complete blood count, blood chemistry, and urinalysis.

指标中文名：

治疗12周每日回顾性鼻部症状评分（Reflective Total Nasal Symptom Score, rTNSS）与基线相比的平均变化

指标类型：

主要指标

Outcome：

Mean Change from Baseline in the daily Reflective Total Nasal Symptom Score (rTNSS) at Week 12

Type：

Primary indicator

测量时间点：

从访视2开始，每日由患者记录并上传

测量方法：

评估内容包括4个鼻部症状（喷嚏、流涕、鼻痒和鼻塞），症状严重程度按4分法评定：0分为无症状；1分为轻度症状（症状轻微，易于忍受）；2分为中度症状（症状明显，令人厌烦，但可以忍受）；3分为重度症状（症状不能忍受，影响日常生活和/或睡眠）。总分为各症状评分之和，范围为0~12。

Measure time point of outcome：

Recorded and uploaded daily by the patient starting from Visit 2.

Measure method：

The rTNSS assesses four nasal symptoms (sneezing, rhinorrhea, nasal itching, and nasal congestion). Symptom severity is rated on a 4-point scale: 0 = absent (no symptom); 1 = mild (mild symptom, easily tolerated); 2 = moderate (bothersome symptom, but tolerable); 3 = severe (severe symptom, hard to tolerate, interfering with daily activities and/or sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12.

指标中文名：

鼻结膜炎相关生活质量问卷(rhino-conjunctivitis quality of life questionnaire, RQLQ)

指标类型：

次要指标

Outcome：

Rhino-Conjunctivitis Quality of Life Questionnaire (RQLQ)

Type：

Secondary indicator

测量时间点：

访视2，访视5，访视8，访视9，访视10

测量方法：

RQLQ用于测量鼻结膜炎成人在日常生活中遇到的问题。它有7个领域（活动限制、睡眠障碍、非鼻/眼症状、实际问题、鼻症状、眼症状和情绪问题）的28个问题。受试者回忆他们在前一周被鼻结膜炎困扰的程度，并以7分制回答每个问题（0-完全没有受损~6-严重受损）。总体RQLQ得分是所有28个回答的平均值，而个别领域得分是这些领域中项目的平均值。

Measure time point of outcome：

Visits 2, 5, 8, 9, and 10.

Measure method：

The RQLQ is used to measure problems experienced by adults with rhino-conjunctivitis in their daily lives. It contains 28 items in 7 domains (activity limitation, sleep problems, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional problems). Subjects recall how bothered they have been by their rhino-conjunctivitis during the previous week and answer each question on a 7-point scale (0 = not impaired at all to 6 = severely impaired). The overall RQLQ score is th

指标中文名：

治疗期间和随访期间不良事件（Adverse Event, AE）/严重不良事件（Serious Adverse Event, SAE）发生情况

指标类型：

次要指标

Outcome：

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment and Follow-up Periods

Type：

Secondary indicator

测量时间点：

访视1到访视10所有时间

测量方法：

所有不良事件和严重不良事件均填写不良事件表或严重不良事件表并上传

Measure time point of outcome：

Throughout Visits 1 to 10.

Measure method：

All AEs and SAEs will be documented in AE forms or SAE forms and uploaded.

指标中文名：

12导联心电图（electrocardiogram, ECG）

指标类型：

次要指标

Outcome：

12-Lead Electrocardiogram (ECG)

Type：

Secondary indicator

测量时间点：

访视1，访视2，访视4，访视6和访视8

测量方法：

采用12导联心电图检测

Measure time point of outcome：

Visits 1, 2, 4, 6, and 8.

Measure method：

A 12-lead ECG will be performed.

指标中文名：

嗅觉评估

指标类型：

次要指标

Outcome：

Olfactory Assessment

Type：

Secondary indicator

测量时间点：

访视2-访视10

测量方法：

采用视觉模拟量表（Visual Analogue Scale，VAS）评估患者的嗅觉情况

Measure time point of outcome：

From visit 2 to visit10

Measure method：

A Visual Analogue Scale (VAS) will be used to assess the patient's sense of smell.

指标中文名：

治疗期间每日rTNSS基线变化曲线下面积（Area Under Curve, AUC）

指标类型：

次要指标

Outcome：

Area Under the Curve (AUC) for the Change from Baseline in Daily rTNSS During the Treatment Period

Type：

Secondary indicator

测量时间点：

访视2-访视10，每日上传后计算

测量方法：

访视2-访视10每日患者情况上传后计算

Measure time point of outcome：

Calculated after daily uploads from Visit 2 to Visit 10.

Measure method：

Calculated after daily uploads from Visit 2 to Visit 10.

指标中文名：

治疗反应的整体评价

指标类型：

次要指标

Outcome：

Overall Evaluation of Treatment Response

Type：

Secondary indicator

测量时间点：

访视2，访视8和访视10

测量方法：

对治疗反应的总体评估基于7分分类量表，受试者在研究结束时评估NARES症状变化或缺乏变化，分为显著改善、中度改善、轻度改善、无变化、轻度恶化、中度恶化、明显恶化等7个类别。

Measure time point of outcome：

Visits 2, 8, and 10.

Measure method：

The overall assessment of treatment response is based on a 7-point categorical scale. Subjects rate the change in NARES symptoms at the end of the study as: significantly improved, moderately improved, mildly improved, no change, mildly worsened, moderately worsened, or significantly worsened.

指标中文名：

治疗期间给药前即时鼻部症状评分（Instant Total Nasal Symptom Score, iTNSS）较基线的平均变化；

指标类型：

次要指标

Outcome：

Mean Change from Baseline in the Instant Total Nasal Symptom Score (iTNSS) Prior to Dosing During the Treatment Period

Type：

Secondary indicator

测量时间点：

访视2-访视8

测量方法：

评估内容包括4个鼻部症状（喷嚏、流涕、鼻痒和鼻塞），症状严重程度按4分法评定：0分为无症状；1分为轻度症状（症状轻微，易于忍受）；2分为中度症状（症状明显，令人厌烦，但可以忍受）；3分为重度症状（症状不能忍受，影响日常生活和/或睡眠）。总分为各症状评分之和，范围为0~12。

Measure time point of outcome：

From visit 2 to visit8

Measure method：

The iTNSS assesses four nasal symptoms (sneezing, rhinorrhea, nasal itching, and nasal congestion). Symptom severity is rated on a 4-point scale: 0 = absent (no symptom); 1 = mild (mild symptom, easily tolerated); 2 = moderate (bothersome symptom, but tolerable); 3 = severe (severe symptom, hard to tolerate, interfering with daily activities and/or sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12.

指标中文名：

治疗期间眼部症状（Total Ocular Symptom Score，TOSS）评分

指标类型：

次要指标

Outcome：

Total Ocular Symptom Score (TOSS) During the Treatment Period

Type：

Secondary indicator

测量时间点：

从访视2开始到访视10，每日由患者记录并上传

测量方法：

评估内容包括3个眼部症状（眼睛发痒/灼热、眼睛流泪/流水、眼睛发红），症状严重程度分级同TNSS。总分为各症状评分之和，范围为0~9。

Measure time point of outcome：

Recorded and uploaded daily by the patient from Visit 2 to Visit 10.

Measure method：

The TOSS assesses three ocular symptoms (ocular itching/burning, tearing/watering, eye redness). Symptom severity is graded identically to the TNSS. The total score is the sum of the individual symptom scores, ranging from 0 to 9.

指标中文名：

治疗期间给药前瞬时总眼症状评分（Instant Total Ocular Symptom Score, iTOSS）较基线的平均变化：

指标类型：

次要指标

Outcome：

Mean Change from Baseline in the Instant Total Ocular Symptom Score (iTOSS) Prior to Dosing During the Treatment Period

Type：

Secondary indicator

测量时间点：

访视2-访视8

测量方法：

评估内容包括3个眼部症状（眼睛发痒/灼热、眼睛流泪/流水、眼睛发红），症状严重程度分级同TNSS。总分为各症状评分之和，范围为0~9。

Measure time point of outcome：

From visit 2 to visit8

Measure method：

The iTOSS assesses three ocular symptoms (ocular itching/burning, tearing/watering, eye redness). Symptom severity is graded identically to the TNSS. The total score is the sum of the individual symptom scores, ranging from 0 to 9.

指标中文名：

治疗期间鼻部症状（TNSS）评分

指标类型：

次要指标

Outcome：

Total Nasal Symptom Score (TNSS) During the Treatment Period

Type：

Secondary indicator

测量时间点：

从访视2开始到访视10，每日由患者记录并上传

测量方法：

评估内容包括4个鼻部症状（喷嚏、流涕、鼻痒和鼻塞），症状严重程度按4分法评定：0分为无症状；1分为轻度症状（症状轻微，易于忍受）；2分为中度症状（症状明显，令人厌烦，但可以忍受）；3分为重度症状（症状不能忍受，影响日常生活和/或睡眠）。总分为各症状评分之和，范围为0~12。

Measure time point of outcome：

Recorded and uploaded daily by the patient from Visit 2 to Visit 10.

Measure method：

The TNSS assesses four nasal symptoms (sneezing, rhinorrhea, nasal itching, and nasal congestion). Symptom severity is rated on a 4-point scale: 0 = absent (no symptom); 1 = mild (mild symptom, easily tolerated); 2 = moderate (bothersome symptom, but tolerable); 3 = severe (severe symptom, hard to tolerate, interfering with daily activities and/or sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12.

指标中文名：

治疗期间患者无症状或轻度症状的天数

指标类型：

次要指标

Outcome：

Number of Days with No or Mild Symptoms During the Treatment Period

Type：

Secondary indicator

测量时间点：

访视2-访视10每日上传后计算

测量方法：

对于每日rTNSS和rTOSS，按以下定义计算治疗期间无症状或轻度症状的天数： 无症状或轻度鼻部症状：流涕、鼻塞、鼻痒、喷嚏各症状评分均≤1分 无症状或轻度眼部症状：眼痒、流泪、眼红各症状评分均≤1分

Measure time point of outcome：

Calculated after daily uploads from Visit 2 to Visit 10.

Measure method：

For the daily rTNSS and rTOSS, the number of days with no or mild symptoms during the treatment period is defined as follows: No or mild nasal symptoms: each individual symptom score (rhinorrhea, nasal congestion, nasal itching, sneezing) is ≤1. No or mild ocular symptoms: each individual symptom score (ocular itching, tearing, eye redness) is ≤1.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

外周血

组织：

Sample Name：

Peripheral Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

鼻刷细胞

组织：

Sample Name：

Nasal Brush Cytology

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

鼻分泌物

组织：

Sample Name：

Nasal Secretion

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由独立的随机化统计师采用SAS? 9.4或更高版本软件分别产生受试者随机表和药物随机表。受试者随机表和药物随机表由IWRS系统工程师导入系统，以实现随机化和药物号的发放。试验人员或其授权人员登陆随机系统申请随机号，将随机系统的随机化信息打印或下载保存。

Randomization Procedure (please state who generates the random number sequence and by what method)：

An independent randomization statistician will generate the subject randomization list and drug randomization list separately using SAS? 9.4 or higher software. The subject and drug randomization lists will be imported into the IWRS (Interactive Web Response System) by the system engineer to implement the randomization and dispense drug assignment numbers. Investigators or their authorized personnel will log into the randomization system to request a randomization number, and shall print or download and save the randomization information.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲

Blinding：

Double blind

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

在完成全部试验并完成数据清理后随文章发表公开原始数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Upon completion of the entire trial and final database lock, the raw data will be made publicly available alongside the publication of the manuscript.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

EDC系统根据原始CRF表制作，通过EDC系统产生电子CRF表，并收集和管理信息

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The Electronic Data Capture (EDC) system, which is developed based on the original Case Report Form (CRF), is utilized to generate electronic CRFs and is responsible for the collection and management of all study data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-10-31 15:21:44