Actively Recruiting
A Multicenter, Randomized, Continuing Trial to Evaluate the 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety, effectiveness, and immune response of two doses of TQH2722 injection in adults with severe chronic sinusitis, with or without nasal polyps. This Phase II, multicenter, randomized trial aims to expand understanding of TQH2722's role in managing this condition over an extended period. Participants receive either 300mg or 600mg of TQH2722 injection every two weeks until week 22, combined with daily use of Mometasone furoate nasal spray at doses of 100-200 mcg until week 32. The study includes two parts (A and B), with similar treatment schedules and follow-up visits to monitor the treatment effects. During the study, participants undergo regular assessments including monitoring for treatment-emergent adverse events up to 32 weeks. Researchers measure changes in sinus imaging scores, smell identification tests, symptom scores, nasal polyp sizes, and immune responses. Safety evaluations include laboratory tests and monitoring for serious adverse events. The total study duration includes treatment and follow-up visits over approximately 32 weeks.
CONDITIONS
Brief 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 to understand the study purpose, process, and possible adverse reactions
- Age between 18 and 75 years, male or female
- Enrolled in the TQH2722 chronic sinusitis study (TQH2722-II-02) and either completed Part A or B end of study visit or withdrew early for reasons other than TQH2722-related adverse events
- Used a stable dose of nasal glucocorticoids for more than 4 weeks before screening; willing to switch to Mometasone furoate nasal spray if previously using other nasal steroids
- Agree not to plan a family for 6 months from consent to last dose and use effective non-drug contraception if of childbearing potential
You will not qualify if you...
- Experienced serious adverse events related to TQH2722 or discontinued therapy because of TQH2722-related adverse events in the main study
- Poor compliance in the main study making continuation unsuitable
- Severe progression or poorly controlled other diseases such as asthma exacerbations requiring medication changes
- Abnormal lab tests: ALT or AST >2.5 times upper limit, total bilirubin >2 times upper limit (except Gilbert syndrome), or creatinine >1.5 times upper limit
- Unstable medical conditions affecting safety or study results, including cardiovascular, liver, kidney, neurological, infectious, autoimmune, malignant tumors, or psychiatric disorders
- Active autoimmune diseases like lupus, rheumatoid arthritis, or multiple sclerosis
- Immunosuppressed or history of serious infections
- Active or recent malignant tumors, with some exceptions based on treatment completion time
- Recent active pulmonary tuberculosis or active hepatitis or infections like HIV or syphilis
- Diagnosis of certain infections or syndromes affecting nasal health
- Recent sinus or nasal surgery within 6 months
- Recent use of certain immunosuppressive or biological therapies within defined timeframes
- Recent live attenuated vaccine or allergen immunotherapy use
- Active infections requiring systemic treatment within 4 weeks before screening
- Asthma with low lung function or recent severe exacerbations or high steroid use
- Conditions preventing completion of assessments such as nasal obstructions or drug allergies
- Pregnancy or lactation
- Alcohol, drug, or known drug dependence
- Any medical or psychiatric condition judged by investigators to pose risk or interfere with study participation or results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 weeks
Participants receive 300mg or 600mg of TQH2722 injection every 2 weeks until week 22, combined with daily Mometasone furoate nasal spray until week 32.
Biweekly visits for injections until week 22; additional visits as needed for assessments up to week 32
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
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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