Actively Recruiting
A Multi-center, Open-label, Phase II Study Evaluating Safety and Efficacy of TQH2722 Injection Combined With Background Treatment in Seasonal Allergic Rhinitis
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2026-03-27
300
Participants Needed
30
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficacy of TQH2722 injection combined with background therapy in people with seasonal allergic rhinitis. This multicenter, open-label, Phase II clinical trial aims to enroll 200 to 300 adults aged 18 to 75 who have seasonal allergic rhinitis with poor symptom control or dissatisfaction with symptom management during the previous pollen season. Participants will receive TQH2722 injection, a humanized monoclonal antibody targeting interleukin-4 receptor alpha, administered in treatment cycles lasting two weeks. The study is single-arm and open-label, meaning all participants receive the injection combined with their background treatment without placebo comparison. The treatment period is followed by assessments at baseline, 2 weeks, and 4 weeks to monitor nasal and ocular symptoms, quality of life, and laboratory tests. During the study, participants will be monitored for adverse events, serious adverse events, and changes in laboratory indicators up to 4 weeks after baseline. Nasal and ocular symptom scores will be recorded daily and retrospectively assessed at 2 and 4 weeks. Blood tests for eosinophil counts, immunoglobulin E levels, and lung function tests for those with asthma will be conducted up to 12 weeks. Participants must comply with study visits, symptom diaries, and safety evaluations throughout the trial, which continues until March 2027.
CONDITIONS
Brief Title
Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Diagnosed with seasonal allergic rhinitis
- Positive allergen test result
- Sufficient pollen exposure during pollen season
- Poor control of seasonal allergic rhinitis symptoms or dissatisfaction with symptom control during prior pollen season
- Morning instantaneous total nasal symptom score (iTNSS) ≥4 on screening and baseline visits, and average retrospective total nasal symptom score (rTNSS) ≥4 over past 6 days
- Good compliance during screening and induction period
- Stable medication use and stable asthma condition if asthma is present
- Voluntary participation with signed informed consent
- Agreement to use effective contraception during study and for 3 months after last treatment
You will not qualify if you...
- Abnormal laboratory test values during screening or randomization
- Any unstable disease affecting safety, study results, or ability to complete study
- Active autoimmune diseases
- Known or suspected immunosuppressant use
- Active or history of malignant tumors
- History of active tuberculosis within 12 months
- Active hepatitis, positive HIV or syphilis antibody during screening
- Helminthic parasitic infections within 6 months without effective treatment
- Recent nasal or sinus surgery or specific medication use
- Intravenous immunoglobulin or plasma exchange within 30 days before screening
- Monoamine oxidase inhibitor use within 14 days
- Allergen immunotherapy within 3 months prior to screening
- Attenuated live vaccine use within 4 weeks prior or planned during study
- Use of systemic Chinese herbal preparations or corticosteroids within specified timeframes
- Acute or chronic infection within 2 weeks before or during screening
- Asthma with FEV1 ≤50% predicted, recent exacerbation, high-dose inhaled corticosteroids, or unstable condition
- Diseases preventing completion of screening or efficacy evaluation
- Malignant or benign tumors in nasal cavity
- Perennial allergic rhinitis with pet hair allergy
- Unable to use nasal corticosteroids or antihistamines
- History of systemic allergy to biological agents
- Pregnancy or breastfeeding
- Alcohol or drug abuse or dependency
- History of major organ or stem cell transplantation
- Any medical or psychiatric condition that increases risk or interferes with study participation
- Forced expiratory volume in one second (FEV1) ≤50% predicted
- Other researcher-judged reasons making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive TQH2722 injection combined with background therapy as a treatment cycle.
1 baseline visit and multiple visits during treatment
Duration - Up to 4 weeks
Participants are monitored for safety and efficacy outcomes after treatment ends.
Approximately 3 follow-up visits
Trial Site Locations
Total: 30 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
5
Hebei University Affiliated Hospital
Baoding, Hebei, China, 071000
Not Yet Recruiting
6
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061017
Not Yet Recruiting
7
Hebei PetroChina Central Hospital
Langfang, Hebei, China, 65000
Not Yet Recruiting
8
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China, 050051
Not Yet Recruiting
9
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China, 50000
Not Yet Recruiting
10
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China, 075000
Not Yet Recruiting
11
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
12
The Central Hospital of Wuhan
Wuhan, Hubei, China, 430014
Not Yet Recruiting
13
Union Hospital, Tongji Medical College, Huazhong University of science and technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
14
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei, China, 430030
Not Yet Recruiting
15
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Not Yet Recruiting
16
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
17
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
18
Yan'an University Xianyang Hospital
Xi'an, Shaanxi, China, 716000
Not Yet Recruiting
19
Shandong Second Provincial General Hospital
Jinan, Shandong, China, 250000
Not Yet Recruiting
20
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
21
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Not Yet Recruiting
22
Zibo Central Hospital
Zibo, Shandong, China, 255036
Not Yet Recruiting
23
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
24
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
25
Second People's Hospital of Chengdu
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
26
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300121
Not Yet Recruiting
27
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Not Yet Recruiting
28
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Not Yet Recruiting
29
Yunnan Provincial Hospital of Chinese Medicine
Kunming, Yunnan, China, 650032
Not Yet Recruiting
30
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
Research Team
Z
Zheng Liu, Doctor
R
Rongfei Zhu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here