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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.