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

NCT06036927 | Completed Phase 2

• 1 other identifier: TQC2731-II-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Chronic Sinusitis; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Nasal Polyp Score (NPS)

  NPS is the sum of the left and right nostril scores evaluated through nasal endoscopy, with a total score range of 0 to 8. NPS is based on polyp grading, with a score of 0-4 based on polyp grading.

  Baseline up to 24 weeks

Secondary Outcomes (25)

• Nasal congestion score (NCS)

  Baseline up to 24 weeks

• Anosmia Score

  Baseline up to 24 weeks

• Total symptom score (TSS)

  Baseline up to 24 weeks

• Visual analogue scale (VAS) for sinusitis

  Baseline up to 24 weeks

• Nasal polyp (NP) surgery time

  Baseline up to 32 weeks

Study Arms (3)

TQC2731 injection 210 mg

EXPERIMENTAL

TQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.

Drug: TQC2731 injection

TQC2731 injection 420 mg

EXPERIMENTAL

TQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.

Drug: TQC2731 injection

TQC2731 matching placebo

PLACEBO COMPARATOR

TQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.

Drug: TQC2731 matching placebo

Interventions

TQC2731 injection DRUG

TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.

TQC2731 injection 210 mg; TQC2731 injection 420 mg

TQC2731 matching placebo DRUG

It'a a placebo injection without active substances.

TQC2731 matching placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects sign informed consent before study, fully understand the purpose, procedures and possible adverse reactions of the study;
• Male and female, ≥18 years old and ≤ 75 years old;
• Bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) who met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of chronic rhinosinusitis (2018);
• Received nasal polyp surgery or received systemic glucocorticoid treatment 2 years before screening;
• Bilateral nasal polyp score (NPS) ≥5 and each nostril was scored ≥ 2 when screening and randomization;
• Nasal congestion score (NCS) ≥2 when screening and randomization;
• Persistent nasal leakage or smell decrease or loss last more than 8 weeks before screening;
• Sinonasal outcome testing 22 (SNOT-22) score ≥ 30 when screening and randomization;
• Subjects received steady dose of intranasal glucocorticoids (INCS) over 4 weeks before screening (subjects agree use Mometasone Furoate Aqueous Nasal Spray (MFNS) while studying);
• Subjects with asthma start inhaled stable dose of glucocorticoid therapy over 4 weeks before screening, and are willing to keep the dose during whole study;
• MFNS medication compliance ≥70%, subjects daily symptom assessment compliance ≥70% through Patient dairy;
• Subjects agree to take effective non-pharmaceutical contraception from signing informed consent to 6 mouth after last administration.

You may not qualify if:

• Presence of conditions/concomitant diseases that affect the evaluation of efficacy, such as:
• Posterior nostril polyps;
• Deviation of the nasal septum resulted in obstruction of at least one nostril;
• Acute sinusitis, nasal infection, or upper respiratory tract infection had occurred 2 weeks before screening, screening period or mediation period;
• Drug induced rhinitis;
• Allergic granulomatous vasculitis (Churg-Strauss syndrome), granuloma with poly vasculitis (Wegener's granuloma), Young syndrome, Kartagener syndrome, or other dysphoric ciliary syndrome, with cystic fibrosis;
• Imaging suspected or confirmed fungal sinusitis;
• NPS cannot be evaluated due to nasal surgery to alter the structure of the lateral nasal wall;
• Subjects with nasal malignancies and benign tumors (papilloma, blood furuncle, etc.)
• Any type of active malignancy or a history of malignancy (Patient with basal cell carcinoma, skin localized squamous cell carcinoma or carcinoma in situ of cervix, can participate in the study if curative treatment was completed for more than 12 months prior to visit 1; Patients with other malignant tumors can participate in the study if curative therapy had been completed for at least 5 years prior to visit 1);
• Active autoimmune disease (including but not limited to Hashimoto's thyroiditis, Graves disease, Inflammatory bowel disease, Primary biliary cholangitis, Systemic lupus erythematosus, Multiple sclerosis and other neuroinflammatory diseases, Psoriasis vulgaris, Rheumatoid arthritis);
• Known or suspected history of immunosuppression, immune disorders, or immune disorders, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioides, pulmonary cysticercosis disease, aspergillosis), even if the infection has been resolved;
• Any intranasal and/or sinus surgery (including polypectomy) within 6 months before screening;
• Uncontrolled epistaxis occurred within 2 months before screening;
• A history of active pulmonary tuberculosis in the 12 months before screening;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (16)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Jieyang People's Hospital

Jieyang, Guangdong, 522000, China

Location

The Fifth Affiliated Hospital Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, 061000, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010000, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Affiliated Zhongshan Hospital Of Dalian University

Dalian, Liaoning, 116001, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710100, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Weifang Second People's Hospital

Weifang, Shandong, 261041, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Chengdu Second People's Hospital

Chengdu, Sichuan, 610000, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 14, 2023
• Study Start: December 8, 2023
• Primary Completion: February 5, 2025
• Study Completion: March 27, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-03

Locations

CN (16)