NCT07107256
Recruiting
Phase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.60 sites in 1 country246 target enrollmentStarted: September 25, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
- Enrollment
- 246
- Locations
- 60
- Primary Endpoint
- Nasal Polyp Score (NPS)
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
TQC2731 injection
Active Comparator
TQC2731 injection/placebo，4 weeks as a treatment cycle.
Intervention: TQC2731 injection (Drug)
Placebo of TQC2731
Placebo Comparator
TQC2731 injection/placebo，4 weeks as a treatment cycle.
Intervention: Placebo of TQC2731 (Drug)
Outcomes
Primary Outcomes
Nasal Polyp Score (NPS)
Time Frame: From baseline to Week 24
Change in Nasal Polyp Score (NPS) from baseline to Week 24 in CRSwNP subjects.
Nasal Congestion Score (NCS)
Time Frame: From baseline to Week 24
Change in Nasal Congestion Score (NCS) from baseline to Week 24 in CRSwNP subjects
Change in nasal polyp score (NPS) from baseline
Time Frame: From baseline to Week 24
Change in nasal polyp score (NPS) from baseline at week 24 in ECRSwNP subjects.
Change from baseline in Nasal Congestion Score (NCS)
Time Frame: From baseline to Week 24
Change from baseline in Nasal Congestion Score (NCS) at Week 24 in ECRSwNP subjects
Secondary Outcomes
- Lund-Mackay score(From baseline to Week 24)
- Olfactory loss score(From baseline to Week 60)
- 22-item Sino-Nasal Outcome Test (SNOT-22) score(From baseline to Week 60)
- Total Symptom Score (TSS)(From baseline to Week 60)
- Visual Analog Scale (VAS)(From baseline to Week 60)
- The proportion of subjects receiving systemic corticosteroid (SCS) rescue or nasal polyp (NP) surgery(From baseline to Week 24)
- Time to systemic corticosteroid (SCS) rescue therapy or nasal polyp (NP) surgery(From baseline to Week 24)
- Numbers of participants with adverse events (AEs) and abnormal laboratory test results(From baseline until 30 days after the last dose)
- Incidence of anti-drug antibodies (ADA)(2 hours pre-dose in Day 1, Day 57, Day 169, Day 253, Day 365, Day 421 and at the time of withdrawal)
- Incidence of neutralizing antibodies (Nab)(2 hours pre-dose in Day 1, Day 57, Day 169, Day 253, Day 365, Day 421 and at the time of withdrawal)
- Blood eosinophil count(2 hours pre-dose in Day 1, Day 169, Day 365, Day 421 and at the time of withdrawal)
- Total Immunoglobulin E (IgE) concentration(2 hours pre-dose in Day 1, Day 169, Day 365, Day 421 and at the time of withdrawal)
- Nasal biopsy tissue eosinophil levels(2 hours pre-dose in Day 1, Day 169, Day 365, Day 421 and at the time of withdrawal)
- Change in nonECRSwNP nasal polyp score (NPS) from baseline(From baseline to Week 24)
- The change from baseline in nonECRSwNP nasal congestion score (NCS)(Week 24)
- The percentage of subjects with an NPS score improvement of ≥1 point from baseline(Baseline through week 60)
- The percentage of subjects with an NPS score improvement of ≥2 points from baseline(Baseline through week 60)
- The percentage of subjects with an improvement of ≥1 point in NCS score compared to baseline(Baseline through week 60)
- The percentage of subjects with an improvement of ≥2 points in NCS score(Baseline through week 60)
Investigators
Study Sites (60)
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