Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

In brief

TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Key facts

Study ID

NCT07107256

Run by

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

People needed

246

Starts

2025-09-25

Expected to finish

2027-09-01

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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；

Where it is running

• Eye&ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Peking University People'S Hospital — Beijing, Beijing Municipality, China
• Henan Provincial People'S Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• The 940th Hospital of Joint Logistics Support force of Chinese People 's Liberation Army — Lanzhou, Gansu, China
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• Shenzhen Second People'S Hospital — Shenzhen, Guangdong, China
• Liuzhou People's Hospital — Liuzhou, Guangxi, China
• Cangzhou Central Hospital — Cangzhou, Hebei, China
• Hebei Petro China Central Hospital — Langfang, Hebei, China
• Hebei Medical University Third Hospital — Shijiazhuang, Hebei, China
• The First Affiliated Hospital of Hebei North University — Zhangjiakou, Hebei, China
• Daqing People's Hospital — Daqing, Heilongjiang, China
• Beijing youan hospital，capital medical university — Beijing, Beijing Municipality, China
• Jingzhou Central Hospital — Jingzhou, Hubei, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• The First People's Hospital of Changde City — Changde, Hunan, China
• People's Hospital of Hunan Province — Changsha, Hunan, China
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China
• Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
• The First People'S Hospital of Lianyungang — Lianyungang, Jiangsu, China
• Zhongda Hospital affiliated to Southeast University — Nanjing, Jiangsu, China
• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.