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Chronic Rhinosinusitis With Nasal PolypsPhase 2NCT06451640

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

A Phase 2 study testing 210mg of TQC2731 injection and 420mg of TQC2731 injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis With Nasal Polyps
What is being tested?
210mg of TQC2731 injection and 420mg of TQC2731 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
16 sitesChina
Study dates
4 Jul 2024to 17 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 38Show fewer
  • 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);
  • Regular use of decongestants (topical or systemic) before screening, short-term use for endoscopy excepted;
  • Patients who received any of the following treatments before screening:
  • Immunosuppressive therapy had been administered within the previous 8 weeks or five half-lives (whichever was longer), (including but not limited to cyclophosphamide, cyclosporine, interferon-γ, azathioprine, methotrexate, mycophenolate mofetil and tacrolimus, etc.);
  • Monoclonal antibody therapy had been administered within the previous 8 weeks or five half-lives (whichever was longer), (Including but not limited to: benralizumab, mepolizumab, omalizumab, resveratrol, dupilumab, etc.);
  • Systemic glucocorticoids were used during the first 28 days;
  • Glucocorticoid-eluting nasal stents were used during the first 6 mouths;
  • Immune globulin or blood products therapy were used during the first 28 days; 6）Live attenuated vaccine was administered for the first 28 days or during the planned study period; 7）Received allergen specific immunotherapy 6 mouth before screening(if being treated at a stable dose and not expected to change during study,3 mouth before screening and 1 mouth before visit 1 were accepted); 8）Join any other study within 3 mouths.
  • Patients with concomitant asthma begin inhaled corticosteroid therapy within the first 4 weeks of the screening period (For patients who have been assessed to maintain a stable dose for at least 4 weeks prior to screening and whose dose has been maintained throughout the entire study period, inhaled corticosteroids can be administered at a dose of ≤ 1000μ Fluticasone propionate or equivalent doses of other inhaled corticosteroids.);
  • Any infectious disease screening indicator that meets the following criteria during screening:
  • Active tuberculosis infection during screening;
  • Hepatitis B virus surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) DNA positive;
  • Anti-hepatitis C virus (Anti-HCV) positive and Hepatitis C virus ribonucleic acid (HCV-RNA) positive;
  • Positive Treponema pallidum antibody (Anti TP) (if the Treponema pallidum serological test is positive, further non treponema pallidum serological tests will be conducted, the latter being negative and judged by the researcher as a patient who has previously been infected with syphilis but has been cured and meets the inclusion criteria);
  • Positive for human immunodeficiency virus antibodies (Anti HIV);
  • Abnormal laboratory test results:
  • Aspartate aminotransferase (AST)>2.5 x upper limit of normal value (ULN);
  • Alanine aminotransferase (ALT)>2.5 x upper limit of normal value (ULN);
  • Creatinine>1.5 x ULN.
  • Pregnant or lactating women;
  • A history of or allergic reaction to Mometasone furoate nasal spray (Nasonex ®) or any component of TQC2731 injection;
  • A history of systemic allergy to any biologic drug(except local injection site reactions);
  • The subjects had poor compliance and were judged unable to complete the study;
  • Any clinically significant abnormal findings, including physical examination, vital signs, 12-lead electrocardiogram, blood biochemistry, blood routine or urine routine, and the researcher's judgment that participating in the trial may put the patient at risk, or may affect the study results or hinder the patient's ability to complete the entire study process.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061017

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • ChengDu Second People's Hospital

    Chengdu, Sichuan, 610021

  • West China Hospital

    Chengdu, Sichuan, 610041

  • Hospital of Chengdu University of TCM

    Chengdu, Sichuan, 610072

  • Affiliated Zhongshan Hospital Of Dalian university

    Dalian, Liaoning, 116001

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434020

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The Afiliated Hospital Of QINGDAO University

    Qingdao, Shandong, 266071

  • Eye＆Ent Hospital of Fudan University

    Shanghai, Shanghai Municipality, 20031

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215000

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300122

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi, 710000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Ongoing Trial Evaluating the Long-term Safety and Efficacy of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps

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

Being tested
210mg of TQC2731 injection, 420mg of TQC2731 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 210mg of TQC2731 injectionDrug

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

  • 420mg of TQC2731 injectionDrug

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

Study groups in NCT06451640
Study groupRoleWhat they receive
210mg of TQC2731 injectionExperimental210mg of TQC2731 injection combined with Mometasone Furoate Aqueous Nasal Spray, 28days as a treatment cycle.
Receives: Drug: 210mg of TQC2731 injection
420mg of TQC2731 injectionExperimental420mg of TQC2731 injection combined with Mometasone Furoate Aqueous Nasal Spray, 28days as a treatment cycle.
Receives: Drug: 420mg of TQC2731 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-related adverse event rate

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

    Measured: Up to thirty six weeks

Secondary outcomes (10)

  1. Treatment-related serious adverse events rate

    The frequency of serious adverse events (SAEs) occurring during treatment at each evaluation time point.

    Measured: Up to thirty six weeks

  2. Abnormal laboratory test indicators

    The number and severity of abnormal laboratory test indicators.

    Measured: Up to thirty six weeks

  3. Nasal Polyp Score (NPS)

    NPS is the sum of the left and right nostril scores evaluated through nasal endoscopy, with a total score range of 0 to 8. NPS is based on polyp grading, with a score of 0-4 based on polyp grading.

    Measured: Baseline up to thirty six weeks

  4. Nasal congestion score (NCS)

    NCS is determined by the subjects based on the severity of the nasal congestion in the past 24 hours. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.

    Measured: Baseline up to thirty six weeks

  5. Anosmia score

    Anosmia Score is evaluated by subjects based on their severity of Anosmia on the day. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.

    Measured: Baseline up to thirty six weeks

  6. Total symptom score (TSS)

    TSS is the sum of nasal congestion, anosmia, and rhinorrhea (the average of anterior and posterior rhinorrhea), with a score range of 0-9 points. The severity is evaluated by the subject and recorded on the subject diary record card.

    Measured: Baseline up to thirty six weeks

  7. Visual analogue scale (VAS) for sinusitis

    VAS for sinusitis is a questionnaire that subjective evaluation of the overall severity of sinusitis by subjects, with a score range of 0-10 points. The higher the score, the greater the impact of sinusitis on the quality of life of the subjects.

    Measured: Baseline up to thirty six weeks

  8. Lund Mackay (LMK) score

    The LMK score is based on the results of sinus Computed Tomography (CT) scans. Evaluated by researchers, divided into left and right sinus systems, with 0-12 points per side and a total score of 0-24 points.

    Measured: Baseline up to twenty eight weeks

  9. Immunogenicity-anti-drug antibody

    Incidence and their titers of Anti-drug antibody (ADA).

    Measured: 1 hour on day 1 before administration, day 197, day 253 during withdrawal

  10. Immunogenicity-neutralizing antibody

    Incidence of neutralizing antibody (Nab).

    Measured: 1 hour on day 1 before administration, day 197, day 253 during withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start4 Jul 2024
  3. Primary completion17 Oct 2025
  4. Study completion17 Oct 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06451640
Sponsor's protocol ID
TQC2731-II-03
Status last verified
Oct 2025
First submitted
30 May 2024
Last updated
20 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 210mg of TQC2731 injection and 420mg of TQC2731 injection in people with Chronic Rhinosinusitis With Nasal Polyps, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 16 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 5 inclusion and 38 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: finished, 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 16 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related adverse event rate (time frame: Up to thirty six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06451640.

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.

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