NCT06036927

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

Completed Phase 2 Last updated 16 April 2025

What this trial tests

Phase 2 trial testing TQC2731 injection in Chronic Sinusitis in 80 participants. Completed in 27 March 2025.

Timeline

8 December 2023

Primary endpoint
5 February 2025

27 March 2025

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	8 December 2023
Primary completion	5 February 2025
Estimated completion	27 March 2025
Sites	16 locations across China

Drugs / interventions tested

• TQC2731 injection — full drug profile →
• TQC2731 matching placebo — full drug profile →

Conditions studied

• Chronic Sinusitis — all drugs for Chronic Sinusitis →
• Nasal Polyps — all drugs for Nasal Polyps →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Sinusitis or Nasal Polyps. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy, safety and pharmacokinetics of TQC2731 injection in the treatment of Chronic Sinusitis with Nasal Polyps.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic monoclonal antibodies in allergy: Targeting IgE, cytokine, and alarmin pathways.
   Eggel A, Pennington LF, Jardetzky TS. · · 2024 · cited 45× · PMID 39158477 · DOI 10.1111/imr.13380
2. Targeting alarmins in asthma: From bench to clinic.
   Akenroye A, Boyce JA, Kita H. · · 2025 · cited 24× · PMID 39855362 · DOI 10.1016/j.jaci.2025.01.017
3. Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.
   Alska E, Łaszczych D, Napiórkowska-Baran K, Szymczak B, et al · · 2025 · cited 13× · PMID 40004611 · DOI 10.3390/jcm14041079
4. Brazilian guideline for the use of immunobiologicals in chronic rhinosinusitis with nasal polyps ‒ 2024 update.
   Anselmo-Lima WT, Romano FR, Tamashiro E, Roithmann R, et al · · 2024 · cited 7× · PMID 38367543 · DOI 10.1016/j.bjorl.2024.101394
5. Chinese Position Paper on Biologic Therapy for Chronic Rhinosinusitis With Nasal Polyps.
   Xian M, Yan B, Song X, Chen J, et al · · 2025 · cited 6× · PMID 40042059 · DOI 10.1111/all.16519
6. An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial.
   Xian M, Lan F, Yan B, Shen S, et al · · 2025 · cited 3× · PMID 41022848 · DOI 10.1038/s41467-025-63682-x
7. Biologics for Chronic Rhinosinusitis With Nasal Polyposis: Current Landscape and Future Directions.
   Chiu J, Fastenberg J, Tong C, Navetta-Modrov B, et al · · 2025 · cited 1× · PMID 41112679 · DOI 10.1002/lio2.70282
8. From the bench to the clinic: basophils and type 2 epithelial cytokines of thymic stromal lymphopoietin and IL-33.
   Obata-Ninomiya K, Jayaraman T, Ziegler SF. · · 2024 · cited 1× · PMID 39654685 · DOI 10.1002/cti2.70020