TQH2722 injection plus regular allergy treatment for seasonal pollen allergy

A Multi-center, Open-label, Phase II, Single-arm Clinical Study Evaluating the Safety and Efficacy of TQH2722 Injection Combined With Background Treatment in Subjects With Seasonal Allergic Rhinitis

This trial will test whether adding TQH2722 injections to usual care helps adults (18–75) with seasonal allergic rhinitis who had poor symptom control during pollen season.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Drugs / interventions: immunotherapy
• Locations: 30 sites (Beijing, Beijing Municipality and 29 other locations)
• Trial ID: NCT07398859 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label Phase II single-arm trial enrolling about 200–300 adults with confirmed seasonal allergic rhinitis. Participants who have positive allergen tests and sufficient pollen exposure will receive TQH2722 injections in addition to their background therapy and be followed for safety and symptom changes. Key symptom entry criteria include morning iTNSS ≥4 at screening and baseline and an average rTNSS ≥4 over the prior 6 days. The primary objectives focus on safety and whether symptoms improve with the addition of TQH2722 during the pollen season.

Who should consider this trial

Good fit: Adults aged 18–75 with confirmed seasonal allergic rhinitis, a positive allergen test, adequate pollen exposure, and documented poor symptom control (iTNSS/rTNSS thresholds) are the intended participants.

Not a fit: People without clear pollen exposure, with well-controlled symptoms, negative allergen testing, or unstable comorbid conditions are less likely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the treatment could reduce nasal allergy symptoms and improve day-to-day functioning during pollen season for people with poorly controlled seasonal allergic rhinitis.

How similar studies have performed: Some injectable biologic approaches for allergic diseases have shown benefit, but TQH2722 itself appears to be a novel agent that has not yet been proven effective for seasonal allergic rhinitis.

Eligibility criteria

Inclusion Criteria:

* Aged 18-75, with no gender restrictions.
* Diagnosed with seasonal allergic rhinitis.
* Positive allergen test result.
* The subjects have sufficient exposure to pollen during the pollen season.
* The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or the subject was dissatisfied with the subjective symptom control.
* Screen for subjects who have a morning iTNSS score of ≥4 on the day of screening; at baseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.
* Good compliance during screening/induction period.
* Subjects with comorbid asthma should have stable medication use before the screening period and have their asthma condition assessed as stable by the investigator or specialist.
* The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance.
* The subjects and their partners agree to take effective contraceptive measures throughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial drug).

Exclusion Criteria:

* Any abnormal laboratory test value during the screening period or randomization.
* Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study results or their interpretation, or hinder the patient's ability to complete the entire study process.
* Patients with active autoimmune diseases.
* Known or suspected immunosuppressants.
* Subjects with active malignant tumors or a history of malignant tumors.
* Screen for individuals with a history of active tuberculosis within the previous 12 months.
* During the screening period, there is active hepatitis, or the presence of human immunodeficiency virus antibody (Anti-HIV) positivity, or syphilis treponema antibody (Anti-TP) positivity.
* Screen for cases diagnosed with helminthic parasitic infections within the previous 6 months, who have not undergone standard treatment or have experienced ineffective standard treatment.
* Subjects who have received specific medications or undergone any nasal or sinus surgery within the specified timeframe.
* Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days before screening.
* Screen subjects who have used monoamine oxidase inhibitors within the previous 14 days.
* Initiate allergen immunotherapy within 3 months prior to screening.
* Screen for individuals who have received attenuated live vaccines within the previous 4 weeks or plan to receive attenuated live vaccines during the study period.
* Screen for systemic Chinese herbal preparations used for the treatment of AR with short- or medium-acting systemic glucocorticoids within 4 weeks, or screen for long-acting Systemic Corticosteroids (SCS) received within the previous 6 weeks.
* Suffering from chronic active or acute infection within 2 weeks before screening or during the screening and import period.
* Patients with concomitant asthma should be excluded if they meet any of the following conditions: a. forced expiratory volume in one second (FEV1) ≤ 50% of the predicted normal value; b. acute exacerbation of asthma within 90 days prior to screening; c. currently using fluticasone propionate at a daily dose of \>1000 μg/day or equivalent doses of other inhaled corticosteroids; d. assessed by the investigator or specialist as having unstable asthma.
* The subject has a concomitant disease that renders them unable to complete the screening period assessment or evaluate the primary efficacy endpoint.
* Suffering from malignant and benign tumors in the nasal cavity.
* Subjects with perennial allergic rhinitis (PAR) who are allergic to pet hair.
* Unable to use nasal corticosteroid sprays or antihistamines.
* Have a history of systemic allergy to any biological agents.
* Women who are pregnant or breastfeeding.
* Individuals who abuse alcohol, use drugs, and have known drug dependency.
* History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
* According to the researcher's judgment, there are any medical or psychiatric symptoms that may put the subjects at risk, interfere with their participation in the study, or interfere with the interpretation of the study results.
* The forced expiratory volume in one second (FEV1) of the subject is less than or equal to 50% of the predicted normal value.
* Other reasons why the researcher believes it is inappropriate to participate in this trial.

Where this trial is running

Beijing, Beijing Municipality and 29 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)
• Hebei University Affiliated Hospital — Baoding, Hebei, China (NOT_YET_RECRUITING)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (NOT_YET_RECRUITING)
• Hebei PetroChina Central Hospital — Langfang, Hebei, China (NOT_YET_RECRUITING)
• Hebei Provincial People's Hospital — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• Hebei Medical University Third Hospital — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Hebei North University — Zhangjiakou, Hebei, China (NOT_YET_RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• The Central Hospital of Wuhan — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Union Hospital, Tongji Medical College, Huazhong University of science and technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Tongji Hospital of Tongji medical college of HUST — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• Yan'an University Xianyang Hospital — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• Shandong Second Provincial General Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (NOT_YET_RECRUITING)
• Zibo Central Hospital — Zibo, Shandong, China (NOT_YET_RECRUITING)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (RECRUITING)
• Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Second People's Hospital of Chengdu — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (NOT_YET_RECRUITING)
• Yunnan Provincial Hospital of Chinese Medicine — Kunming, Yunnan, China (NOT_YET_RECRUITING)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Zheng Liu, Doctor

Conditions: Seasonal Allergic Rhinitis