Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps (NCT07107256) | Clinical Trial Compass
RecruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
China246 participantsStarted 2025-09-25
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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).
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What they're measuring
1
Nasal Polyp Score (NPS)
Timeframe: From baseline to Week 24
2
Nasal Congestion Score (NCS)
Timeframe: From baseline to Week 24
3
Change in nasal polyp score (NPS) from baseline
Timeframe: From baseline to Week 24
4
Change from baseline in Nasal Congestion Score (NCS)
Timeframe: From baseline to Week 24
Trial details
NCT IDNCT07107256
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.