New antibody injection could shrink nasal polyps and ease breathing

NCT ID NCT07107256

Disease control Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests an injectable drug called TQC2731 in 246 adults with chronic sinusitis and nasal polyps. The drug targets a protein involved in inflammation. Researchers will measure changes in polyp size and nasal congestion over 24 weeks compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQC2731 injection (a lab-made antibody that blocks inflammation)
What this could lead to: If it works, this could offer a new treatment option to shrink nasal polyps and ease congestion for people with chronic sinusitis.
What could go wrong: This is a phase 3 trial, but results may not show clear benefit over placebo. Side effects from blocking the immune system are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 246 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse reactions. * Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender. * Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)" * At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg/kg/day or 15-30 mg/day or equivalent for minimum 5 days) within 2 years before screening, with persistent bilateral CRSwNP; AND/OR contraindication/intolerance to systemic corticosteroids; AND/OR prior nasal polyp surgery performed more than 6 months before screening. * Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and randomization. * Nasal Congestion Score (NCS) ≥2 at screening (daily average) and randomization (weekly average). * Persistent symptoms of rhinorrhea and/or hyposmia/anosmia for over 8 weeks prior to screening. * 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and randomization. * Stable dose of intranasal corticosteroids (INCS) for \>4 weeks prior to screening (subjects using non-mometasone furoate nasal spray \[MFNS\] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the study). * Subjects with comorbid asthma must have had stable asthma symptoms for ≥4 weeks prior to screening (if using medications, such as inhaled corticosteroids, the same dose must have been stably maintained for ≥4 weeks before screening, and the dose is assessed to remain stable during the first phase). * The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%, and the adherence to daily symptom assessment records in the subjects' electronic logs was also greater than 70%. Note: Days with missing electronic log data were considered non-adherent to this criterion. * Agreement to practice effective non-pharmacologic contraception from informed consent until 6 months post-final dose, for subjects/partners of childbearing potential. Exclusion Criteria: * Conditions/Diseases Affecting Efficacy Evaluation * Nasal septum deviation causing ≥1 nostril obstruction； * Perforation of the nasal septum * Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening/run-in periods； * Rhinitis medicamentosa； * Eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young's syndrome, Kartagener's syndrome, other ciliary dyskinesia syndromes, or cystic fibrosis； * Suspected or confirmed fungal sinusitis by imaging； * Prior nasal surgery altering lateral wall structure precluding NPS assessment； * Nasal malignancies or benign tumors (e.g., papilloma, hemangioma)； * Any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to screening. * Uncontrolled epistaxis within 2 months prior to screening. * Regular use of decongestants (topical or systemic) prior to screening, except for short-term use during endoscopic examinations. * Patients who have received any of the following treatments prior to randomization: * Treatment with immunosuppressants (including but not limited to: cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate, tacrolimus, Secukinumab) within 8 weeks or 5 half-lives prior to screening (whichever is longer)； * Treatment with any monoclonal antibodies (including but not limited to: benralizumab, mepolizumab, omalizumab, dupilumab, or other similar drugs \[e.g., TSLP blockers\]) within 8 weeks or 5 half-lives prior to screening (whichever is longer). * Patients who used medium- or short-acting systemic corticosteroids (SCS, including oral, intravenous, or intramuscular administration), systemic traditional Chinese medicine preparations for treating CRS within 4 weeks prior to screening, or received long-acting SCS (e.g., triamcinolone acetonide injection) within 6 weeks prior to screening, or who plan to receive the aforementioned medications during the study period. * Use of corticosteroid-eluting nasal stents within 6 months prior to screening; * Treatment with immunoglobulins or blood products within 28 days prior to screening; * Administration of live attenuated vaccines within 28 days prior to screening or planned during the study period; * Allergen-specific immunotherapy within 6 months prior to screening (allowed only if: initiated \>3 months before screening, maintained at a stable dose for ≥1 month before Visit 1, and no planned dose changes during the study)； * Participation in other drug/medical device clinical trials within 3 months prior to screening (based on last administration/use). * Use nasal antihistamines (such as olopatadine nasal spray, azelastine nasal spray, levocabastine nasal spray, etc.) for the first 3 days. * Screening for a history of active pulmonary tuberculosis within the past 12 months； * Exclusion of infections within the last 14 days requiring systemic antibiotic, antiviral, antifungal, antiparasitic, or antiprotozoal therapy; * Exclusion of subjects diagnosed with helminthic parasitic infection in the past 6 months who either did not receive standard treatment or had treatment failure； * Known or suspected history of immunosuppression, immune dysfunction, or immune dysregulation, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; Or there is an unusual frequency, recurrence, or prolonged infection (as judged by the investigator). * The forced expiratory volume in the first second (FEV1) of the subjects during the screening/introduction period was ≤ 50% of the normal predicted value. * Patients with comorbid asthma who meet any of the following criteria: Asthma exacerbation within 90 days before screening, or current use of inhaled corticosteroids (ICS) at a daily dose higher than 1000μg fluticasone (or equivalent). Definition of Asthma Acute Exacerbation: * Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline OCS) for at least 3 consecutive days due to worsening asthma; a single injection of depot long-acting corticosteroids may be considered equivalent to a 3-day course of systemic corticosteroids. * An emergency department or urgent care center visit due to asthma requiring systemic corticosteroids (as described above) (defined as evaluation and treatment in the emergency department or urgent care center lasting \<24 hours). * Hospitalization due to asthma (defined as admission to a medical facility and/or evaluation and treatment in a healthcare setting lasting ≥24 hours). * Use of leukotriene antagonists/modulators prior to randomization (subjects who have been on a stable dose of leukotriene modulators for ≥30 days continuously prior to randomization may be enrolled); * Presence of other concurrent active or clinically significant respiratory diseases that, in the investigator's judgment, may significantly impact the study, such as active tuberculosis, lung cancer, bronchiectasis, pulmonary sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, or other active pulmonary conditions * Subjects who have undergone lobectomy or lung volume reduction surgery within 12 months prior to the start of the study; * Exclusion of subjects with cardiovascular conditions (including but not limited to unstable ischemic heart disease, heart failure, uncontrolled hypertension, myocardial infarction, significant arrhythmias, long QT syndrome, or Fridericia-corrected QT interval (QTcF) prolongation \[≥450 ms in men, ≥470 ms in women\]) if the investigator deems participation could compromise safety or study outcome interpretation; * Exclude individuals with difficult venous access or a history of vasovagal syncope (needle/blood-related); * Exclusion of any current active malignancy or history of malignancy (Patients with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible if curative treatment was completed \>12 months before V1. Patients with other malignancies are eligible if curative treatment was completed at least 5 years before V1). * Presence of active autoimmune diseases (including but not limited to Hashimoto's thyroiditis with hyperthyroidism, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory disorders, psoriasis vulgaris, and rheumatoid arthritis); * Exclusion if any infectious disease screening indicator meets the following criteria during screening; * Exclusion of subjects who are positive for hepatitis B virus surface antigen (HBsAg). * Hepatitis B virus core antibody (HBcAb) with detectable Hepatitis B Virus (HBV)-DNA. * Exclude if Hepatitis C Virus (HCV) antibody-positive and HCV-RNA positive, or if previously treated for HCV (regardless of current HCV-RNA status). * Anti-Treponema pallidum antibody (Anti-TP) positive (if syphilis serology is positive, a non-treponemal test must be performed; subjects with a negative non-treponemal test and deemed by the investigator as previously cured are eligible). * Anti-HIV positive * Abnormal laboratory test results: * White blood cell count \<3.5 × 10⁹/L; * Aspartate aminotransferase (AST) \>2.5 × upper limit of normal (ULN); * Alanine aminotransferase (ALT) \>2.5 × ULN; * Total bilirubin \>2 × ULN; * Creatinine \>1.5 × ULN * Any clinically significant abnormal findings during the import period, including physical examination, vital signs, 12-lead ECG, blood biochemistry, hematology, or urinalysis, which in the investigator's judgment may place the patient at risk, affect study results, or impair the patient's ability to complete the entire study * Women who are pregnant or lactating. * Those who were still smokers or had quit smoking for less than six months at the time of screening. * Exclude those with regular excessive alcohol consumption (\>14 units/week for females or \>21 units/week for males) in the past 6 months, inability to abstain during the trial, or a positive breath alcohol test. * History of drug abuse within the past 2 years, or a positive drug abuse screening result. * Subjects with a known history of hypersensitivity or allergic reaction to any ingredient of mometasone furoate nasal spray (Nasonex®) or TQC2731 injection. * Exclusion for any history of systemic allergic reaction to biologic agents (local injection site reactions excluded). * The participant demonstrated poor adherence and was deemed unable to complete the study. * Any medical or psychiatric condition that, in the judgment of the investigator or the sponsor's medical reviewer, may affect the subject's safety throughout the study or impede the subject's ability to complete the entire study process or interfere with the interpretation of study results, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic disorders, psychiatric illnesses, or major physical disabilities.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps (CRSWNP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

60 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING

Hohhot, Inner Mongolia, 10000, China
Affiliated Hospital of Yangzhou Univrtsity
NOT_YET_RECRUITING

Yangzhou, Jiangsu, 225000, China
Affiliated Zhongshan Hospital Of Dalian University
NOT_YET_RECRUITING

Dalian, Jilin, 116001, China
Affilited hangzhou first people's hospital, school of medicine, westlakeuniversity
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310006, China
Beijing youan hospital，capital medical university
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100069, China
Cangzhou Central Hospital
NOT_YET_RECRUITING

Cangzhou, Hebei, 61012, China
Chengdu Second People's Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610017, China
Chifeng Municipal Hospital
NOT_YET_RECRUITING

Chifeng, Inner Mongolia, 24000, China
China Medical University Affiliated Shengjing Hospital
NOT_YET_RECRUITING

Shenyang, Liaoning, 110004, China
China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130000, China
Daqing People's Hospital
NOT_YET_RECRUITING

Daqing, Heilongjiang, 163316, China
Eye&ENT Hospital of Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 200031, China
Fengcheng People's Hospital
NOT_YET_RECRUITING

Fengcheng, Jiangxi, 331100, China
First Hospital of Shanxi Medical University
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030045, China
Ganzhou People's Hospital
NOT_YET_RECRUITING

Ganzhou, Jiangxi, 341000, China
Hebei Medical University Third Hospital
NOT_YET_RECRUITING

Shijiazhuang, Hebei, 065799, China
Hebei Petro China Central Hospital
NOT_YET_RECRUITING

Langfang, Hebei, 650000, China
Henan Provincial People'S Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, 450003, China
Jiangnan University Medical Center
NOT_YET_RECRUITING

Wuxi, Jiangsu, 214000, China
Jingzhou Central Hospital
NOT_YET_RECRUITING

Jingzhou, Hubei, 434000, China
Linfen Central Hospital
NOT_YET_RECRUITING

Lifen, Shanxi, 041000, China
Liuzhou People's Hospital
NOT_YET_RECRUITING

Liuzhou, Guangxi, 545200, China
Ningbo No.2 Hospital
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315010, China
Peking University People'S Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100044, China
People's Hospital of Hunan Province
NOT_YET_RECRUITING

Changsha, Hunan, 410002, China
Qingdao Municipal Hospital
NOT_YET_RECRUITING

Qingdao, Shandong, 266000, China
Renji Hospital,Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200127, China
Shandong Second Province General Hospital
NOT_YET_RECRUITING

Jinan, Shandong, 250021, China
ShangRao People's Hospital
NOT_YET_RECRUITING

Shangrao, Jiangxi, 334000, China
Shanghai Sixth People's Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200233, China
Shenzhen Second People'S Hospital
NOT_YET_RECRUITING

Shenzhen, Guangdong, 518035, China
Taizhou First People's Hospital
NOT_YET_RECRUITING

Taizhou, Zhejiang, 318020, China
The 940th Hospital of Joint Logistics Support force of Chinese People 's Liberation Army
NOT_YET_RECRUITING

Lanzhou, Gansu, 730050, China
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Hebei North University
NOT_YET_RECRUITING

Zhangjiakou, Hebei, 75000, China
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING

Kunming, Yunnan, 650032, China
The First Affiliated Hospital of NanChang University
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING

Xiamen, Fujian, 361000, China
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING

Ürümqi, Xinjiang, 830000, China
The First People'S Hospital of Lianyungang
NOT_YET_RECRUITING

Lianyungang, Jiangsu, 222000, China
The First People's Hospital of Changde City
NOT_YET_RECRUITING

Changde, Hunan, 415000, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710004, China
The Second Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, Anhui, 230601, China
The Second Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510405, China
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410013, China
The first hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130000, China
Tianjin First Central Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300190, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430022, China
West China Hospital of Si chuan University
NOT_YET_RECRUITING

Chengdu, Sichuan, 610000, China
Xuzhou Medical University Affiliated Hospital
NOT_YET_RECRUITING

Xuzhou, Jiangsu, 221000, China
Yan'an University Xianyang Hospital
NOT_YET_RECRUITING

Xianyang, Shaanxi, 712000, China
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING

Yantai, Shandong, 264000, China
Yuncheng Central Hospital，Shanxi Province
NOT_YET_RECRUITING

Yuncheng, Shanxi, 44099, China
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310014, China
Zhongda Hosiptal Southeast University
NOT_YET_RECRUITING

Fuyang, Anhui, 236600, China
Zhongda Hospital affiliated to Southeast University
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210009, China
Zhongshan Hospital, Fudan University
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Zibo Central Hospital
NOT_YET_RECRUITING

Zibo, Shandong, 255020, China

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