Actively Recruiting
Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-02-27
120
Participants Needed
28
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after understanding the study purpose, process, and possible side effects
- Aged 18 to 75 years, male or female
- Previously enrolled in the TQH2722 chronic sinusitis study (TQH2722-II-02) and either completed required treatment and end-of-study visit or withdrew early for reasons other than TQH2722-related adverse events
- Used a stable dose of nasal glucocorticoids (Mometasone furoate nasal spray) for more than 4 weeks before screening
- Agree not to have a family plan for 6 months from consent to last dose and use effective non-drug contraception with partners of childbearing age
You will not qualify if you...
- Experienced serious adverse events related to TQH2722 or discontinued TQH2722 due to adverse events in the main study and deemed unsuitable for continuation
- Poor compliance in the main study making continuation unlikely
- Severe progression or poorly controlled concurrent diseases like asthma exacerbations requiring medication changes
- Abnormal liver or kidney function tests above specified limits
- Unstable medical conditions that may affect safety or study results, including heart, liver, kidney, neurological, psychiatric, or metabolic disorders
- Active autoimmune diseases
- Known or suspected immunosuppression or history of invasive opportunistic infections
- Active or recent malignancies except certain skin or cervical cancers treated over 12 months ago, or other cancers treated over 5 years ago
- Active pulmonary tuberculosis within 12 months before screening
- Active hepatitis B, hepatitis C, HIV, or untreated syphilis
- Helminthic infection within 6 months prior to screening without successful treatment
- Sinus or nasal surgery within 6 months prior to screening
- Recent use of monoclonal antibodies, immunosuppressive therapy, or non-biological agents within specified washout periods
- Recent use of intravenous immunoglobulin or plasma exchange
- Recent start or planned changes in allergen immunotherapy
- Recent live attenuated vaccine use or plans to receive it during the study
- Active infections requiring systemic treatment within 4 weeks prior to screening
- Severe or poorly controlled asthma
- Nasal conditions preventing study assessments like deviated septum causing obstruction or drug rhinitis
- Nasal malignancies or benign tumors
- Allergy or intolerance to Mometasone furoate nasal spray
- History of systemic allergy to biological agents
- Pregnant or lactating women
- Alcohol, drug, or known drug dependence
- Any medical or psychiatric condition posing risk or interfering with study participation or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Not Yet Recruiting
3
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518035
Not Yet Recruiting
4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
6
Cangzhou Central Hospital
Cangzhou, Heibei, China, 061017
Not Yet Recruiting
7
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
8
Union Hospital, Tongji Medical College, Huazhong University of science and technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
9
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China, 430060
Not Yet Recruiting
10
Loudi Central Hospital
Changsha, Hunan, China, 417000
Not Yet Recruiting
11
Baotou Central Hospital
Baotou, Inner Mongolia, China, 014000
Not Yet Recruiting
12
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
13
Jilin Provincial People's Hospital
Changchun, Jilin, China, 130021
Not Yet Recruiting
14
The Affiliated Hospital of Yanbian University
Yanji, Jilin, China, 133002
Not Yet Recruiting
15
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Not Yet Recruiting
16
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
17
The Central Hospital of Shenyang Medical College
Shenyang, Liaoning, China, 110075
Not Yet Recruiting
18
Shandong Second People's Hospital
Jinan, Shandong, China, 250299
Not Yet Recruiting
19
Weihai Central Hospital
Weihai, Shandong, China, 264499
Not Yet Recruiting
20
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Not Yet Recruiting
21
Zibo Central Hospital
Zibo, Shandong, China, 255036
Not Yet Recruiting
22
Zibo Central Hospital
Zibo, Shandong, China, 255036
Not Yet Recruiting
23
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, China, 200127
Not Yet Recruiting
24
First Hospital of Shangxi Medical University
Taiyuan, Shangxi, China, 030001
Not Yet Recruiting
25
Chengdu Second People's Hospital
Chengdu, Sichuan, China, 610021
Not Yet Recruiting
26
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830011
Not Yet Recruiting
27
Taizhou central hospital(Taizhou university hospital)
Taizhou, Zhejiang, China, 318000
Not Yet Recruiting
28
Wenling First People's Hospital
Wenling, Zhejiang, China, 317599
Not Yet Recruiting
Research Team
L
Luo Zhang, Postdoctoral
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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