A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps

NCT06451640 | Completed Phase 2

• 1 other identifier: TQC2731-II-03
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 16

Brief Summary

This study aims to evaluate the efficacy and safety of TQC2731 injection in the treatment of chronic sinusitis with nasal polyps.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Treatment-related adverse event rate

  The frequency of treatment-related adverse events (TEAEs) occurring during treatment at each evaluation time point.

  Up to thirty six weeks

Secondary Outcomes (10)

• Treatment-related serious adverse events rate

  Up to thirty six weeks

• Abnormal laboratory test indicators

  Up to thirty six weeks

• Nasal Polyp Score (NPS)

  Baseline up to thirty six weeks

• Nasal congestion score (NCS)

  Baseline up to thirty six weeks

• Anosmia score

  Baseline up to thirty six weeks

Study Arms (2)

210mg of TQC2731 injection

EXPERIMENTAL

210mg of TQC2731 injection combined with Mometasone Furoate Aqueous Nasal Spray, 28days as a treatment cycle.

Drug: 210mg of TQC2731 injection

420mg of TQC2731 injection

EXPERIMENTAL

420mg of TQC2731 injection combined with Mometasone Furoate Aqueous Nasal Spray, 28days as a treatment cycle.

Drug: 420mg of TQC2731 injection

Interventions

210mg of TQC2731 injection DRUG

TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.

210mg of TQC2731 injection

420mg of TQC2731 injection DRUG

TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.

420mg of TQC2731 injection

Eligibility Criteria

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

You may qualify if:

• Subjects sign informed consent before study, fully understand the purpose, procedures and possible adverse reactions of the study;
• Male and female, ≥18 years old;
• Participate in the clinical study of TQC2731 for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) (study number TQC2731-II-02) and meet the following criteria "a" or "b": a. Participants complete the prescribed treatment according to the protocol requirements and complete end of treatment (EOT) visits; b. The subject withdrew early due to poor compliance or other objective reasons other than TQC2731 related adverse events (AEs), and completed the early withdrawal visit according to the plan. After evaluation by the researcher and sponsor, the factors that led to the subject's early termination of the main study treatment have disappeared/no longer affect the subject's participation in this continuing study;
• Subjects used steady dose of intranasal glucocorticoids (INCS) over 4 weeks before screening (subjects willing to use Mometasone Furoate Aqueous Nasal Spray (MFNS) while studying);
• Subjects agree from sign informed consent to last administration over 6 mouth without Family planning，and take effective non-pharmaceutical contraception.

You may not qualify if:

• In the main study (TQC2731-II-02), SAE related to TQC2731 occurred, or TQC2731 treatment was terminated due to AE related to TQC2731. After discussion between the investigator and the sponsor, it was determined that the subject was not suitable to continue receiving TQC2731 treatment;
• The subjects had poor compliance in the main study and were deemed unable to complete this continuing study by the researchers;
• During the main study (TQC2731-II-02), any serious progression or poorly controlled comorbidities were found (such as asthma exacerbation requiring adjustment of background medication), and the main investigator determined that the subject was not suitable to participate in the trial;
• Presence of conditions/concomitant diseases that affect the evaluation of efficacy, e.g.
• Posterior nostril polyps;
• Imaging suspected or confirmed fungal sinusitis;
• Nasal polyp score(NPS) cannot be evaluated due to nasal surgery to alter the structure of the lateral nasal wall;
• Subjects with nasal malignancies and benign tumors (papilloma, blood furuncle, etc.).
• Any type of active malignancy or a history of malignancy (Patient with basal cell carcinoma, skin localized squamous cell carcinoma or carcinoma in situ of cervix, if curative treatment was completed for more than 12 months prior to visit 1 can join the study; Other malignant tumors can join the study if patients had completed curative therapy for at least 5 years prior to visit 1);
• Active autoimmune disease;
• Known or suspected history of immunosuppression, immune dysfunction, or immune dysfunction, including but not limited to invasive opportunistic infections, even if the infection has subsided;
• Uncontrolled epistaxis occurred within 2 months before screening;
• Infection requiring treatment with systemic antibacterial, antiviral, antifungal, antiparasitic, or antiparasitic agents occurred within 14 days before screening;
• Helminth parasite infection was diagnosed within 24 weeks prior to screening and had not received or failed to respond to standard treatment;
• Leukotriene antagonists/modulators were used while screening(using a stable dose of leukotriene modulator for ≥30 days before screening was accepted);

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (16)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, 061017, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215000, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Affiliated Zhongshan Hospital Of Dalian university

Dalian, Liaoning, 116001, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710000, China

Location

The Afiliated Hospital Of QINGDAO University

Qingdao, Shandong, 266071, China

Location

Eye＆Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, 20031, China

Location

ChengDu Second People's Hospital

Chengdu, Sichuan, 610021, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Hospital of Chengdu University of TCM

Chengdu, Sichuan, 610072, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300122, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: July 4, 2024
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

CN (16)