Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps

NCT06439381 | Recruiting Phase 2

• 1 other identifier: TQH2722-II-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 28

Brief Summary

This is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events (TEAE)

  Frequency of treatment emergent adverse events (TEAE) occurring during treatment.

  Up to 32 weeks

Secondary Outcomes (15)

• Serious adverse events (SAEs)

  Up to 32 weeks

• Abnormal laboratory test indicators

  Up to 32 weeks

• Changes in Lund Mackay score assessed by CT from baseline

  Up to 24 weeks

• Changes in the University of Pennsylvania Smell Identification Test (UPSIT)

  Up to 32 weeks

• Changes in Nasal Total Symptom Score from baseline

  Up to 32 weeks

Study Arms (1)

300mg/600mg of TQH2722 injection in Part A or B

EXPERIMENTAL

For Part A or Part B, 300mg/600mg of TQH2722 injection was administered every 2 weeks until week 22, combined with Mometasone furoate nasal spray of 100-200μg/ day until week 32.

Drug: 300mg/600mg of TQH2722 injection

Interventions

300mg/600mg of TQH2722 injection DRUG

TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.

300mg/600mg of TQH2722 injection in Part A or B

Eligibility Criteria

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

You may qualify if:

• Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
• Age 18-75 years old (including the threshold), male or female;
• Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" :
• Subjects completed prescribed treatment as required and completed Part A end of study (EOS) visit;
• The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors.
• Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.
• Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for subjects who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS), subjects were willing to switch to MFNS during the study);
• Subjects agree not to have a family plan for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age.
• Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
• Age 18-75 years old (including the threshold), male or female;
• Enroll in the clinical study of TQH2722 for chronic sinusitis with or without nasal polyps (study number TQH2722-II-02) and meet the following criteria "a" or "b" :
• Subjects completed prescribed treatment as required and completed Part B EOS visit;
• The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors.
• Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.
• Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4 weeks prior to screening (for subjects who had used other INCS prior to screening than intranasal Mometasone furoate nasal spray (MFNS), subjects were willing to switch to MFNS during the study);

You may not qualify if:

• In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-related AE led to the discontinuation of TQH2722 therapy, and after discussion between the investigator and sponsor, the subject was deemed unsuitable for continuation of TQH2722 therapy.
• The subjects had poor compliance in the main study, and the researchers judged that they could not complete the continuing study.
• During the main study (TQH2722-II-02), any severe progression or poorly controlled concomitant disease (such as asthma exacerbation requiring adjustment of background medication) is identified and the subject is deemed unfit to participate by the principal investigator;
• Any of the following laboratory test values are abnormal during the screening period:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN);
• Total bilirubin \> 2 x ULN (except indirect bilirubin elevation secondary to Gilbert syndrome);
• Creatinine \> 1.5×ULN;
• Any medical condition, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major limb disorders, that the investigator believes is unstable and may affect the patient's safety throughout the study period, or affect the study results or their interpretation, or interfere with the patient's ability to complete the entire study process.For example, but not limited to: ischemic heart disease, left ventricular failure, arrhythmia, uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease, etc.;
• Patients with active autoimmune diseases (including, but not limited to, Hashimoto 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 immunosuppressed individuals, including but not limited to a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cyst disease, aspergillosis), even if the infection has resolved;
• Subjects with active malignant tumors or a history of malignant tumors:Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ who had completed curative treatment for at least 12 months prior to visit 1 could be enrolled in this study; patients with other malignancies could be enrolled if they had completed curative treatment for at least 5 years prior to visit 1;
• A history of active pulmonary tuberculosis within 12 months prior to screening;
• Diagnosis of helminthic infection within 6 months prior to the screening period, failure to receive standard treatment or failure to respond to standard treatment;
• Subjects who received the following treatments:
• Had sinus surgery or nasal sinus surgery within 6 months prior to screening (visit 1).

Sponsors & Collaborators

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

Study Sites (28)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

NOT YET RECRUITING

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, 518035, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

Cangzhou Central Hospital

Cangzhou, Heibei, 061017, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of science and technology

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University Hubei General Hospital

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

Loudi Central Hospital

Changsha, Hunan, 417000, China

NOT YET RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, 014000, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Jilin Provincial People's Hospital

Changchun, Jilin, 130021, China

NOT YET RECRUITING

The Affiliated Hospital of Yanbian University

Yanji, Jilin, 133002, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

NOT YET RECRUITING

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110004, China

NOT YET RECRUITING

The Central Hospital of Shenyang Medical College

Shenyang, Liaoning, 110075, China

NOT YET RECRUITING

Shandong Second People's Hospital

Jinan, Shandong, 250299, China

NOT YET RECRUITING

Weihai Central Hospital

Weihai, Shandong, 264499, China

NOT YET RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

NOT YET RECRUITING

Zibo Central Hospital

Zibo, Shandong, 255036, China

NOT YET RECRUITING

Zibo Central Hospital

Zibo, Shandong, 255036, China

NOT YET RECRUITING

Renji Hospital Shanghai Jiaotong University School of Medical

Shanghai, Shanghai Municipality, 200127, China

NOT YET RECRUITING

First Hospital of Shangxi Medical University

Taiyuan, Shangxi, 030001, China

NOT YET RECRUITING

Chengdu Second People's Hospital

Chengdu, Sichuan, 610021, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

NOT YET RECRUITING

Taizhou central hospital(Taizhou university hospital)

Taizhou, Zhejiang, 318000, China

NOT YET RECRUITING

Wenling First People's Hospital

Wenling, Zhejiang, 317599, China

NOT YET RECRUITING

Central Study Contacts

Luo Zhang, Postdoctoral

CONTACT

13910830399; dr.luozhang@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (28)