Evaluating TQH2722 Injection for Seasonal Allergic Rhinitis

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH2722 Injection Combined With Background Therapy in Patients With Seasonal Allergic Rhinitis

This study is testing a new injection called TQH2722 to see if it can help people with seasonal allergies feel better when their current treatments aren't working well enough.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 30 sites (Beijing, Beijing and 29 other locations)
• Trial ID: NCT06760182 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and immunogenicity of TQH2722 injection in patients with seasonal allergic rhinitis who are already receiving treatment with mometasone furoate nasal spray and loratadine. The study aims to include 168 patients who have not responded adequately to standard treatments. Participants will be compared to a placebo group to assess the effectiveness of the injection in alleviating symptoms of allergic rhinitis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed seasonal allergic rhinitis and inadequate symptom control despite standard treatments.

Not a fit: Patients with well-controlled allergic rhinitis or those who do not meet the specific diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients suffering from seasonal allergic rhinitis who do not respond to existing therapies.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for allergic rhinitis.

Eligibility criteria

Inclusion Criteria:

* Aged 18 to 75 years at the screening period.
* Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022)
* Positive of at least 1 allergen skin prick test(SPT) and/or serum-specific IgE within 1 year before enrollment.
* Subjects have sufficient pollen exposure during the pollen season:
* Subjects' medical history suggested that SAR symptoms were poorly controlled or subjects' subjective symptoms were not satisfactorily controlled after drug treatment during the same pollen season in the past.
* On the day of screening, the iTNSS score in the morning was ≥4; At baseline visit, the morning iTNSS was ≥4 points, and the average score of the past 6 rTNSS was ≥6 points;
* At baseline visit, the absolute value of peripheral blood eosinophils was ≥0.15×109/L;
* During the screening/induction period, the subjects had good compliance;
* Subjects with asthma who were assessed by the investigator or specialist as having stable asthma;
* Voluntary participation in this trial and signing the informed consent form
* Subjects (including partners) have no pregnancy and voluntarily take one or more non-pharmaceutical measures for contraception at period from drug administration to 6 months after the last study drug administration

Exclusion Criteria:

* Laboratory test values did not meet the requirements during screening or randomization
* Any disease that the investigator believes interferes with the patient's ability to complete the entire course of the study;
* Patients with active autoimmune disease
* People with known or suspected immunosuppression
* Subjects with active malignancy or a history of malignancy;
* Active hepatitis or hepatitis B was present during the screening period; Or human immunodeficiency virus antibody (Anti-HIV) positive, or treponema pallidum antibody (Anti-TP) positive;
* Diagnosis of helminthic infection within 6 months prior to screening, not receiving standard treatment or not responding to standard treatment;
* Subjects who have undergone nasal surgery or sinus surgery within 6 months before screening
* Subjects have concomitant medical conditions that preclude them from completing the screening period assessment or evaluating the primary efficacy endpoint;
* Subjects with nasal malignancies and benign tumors;
* History of hypersensitivity to any content of the study drugs or its excipients
* Subjects with a history of systemic allergy to any biological agent;
* Pregnant or lactating women;
* Alcohol, drug and known drug dependence;
* Have a history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
* Any medical or psychiatric condition that, in the investigator's judgment, puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results;
* Any condition that the investigator or primary physician believes may not be appropriate for participating the study

Where this trial is running

Beijing, Beijing and 29 other locations

• Peking University First Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Peking University People's Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Peking University Third Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Gansu Provincial Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• Hebei Medical University Third Hospital — Shijiazhuang, 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 (Recruiting)
• Baotou Central Hospital — Baotou, Inner Mongolia, China (Not_yet_recruiting)
• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China (Not_yet_recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• Ansteel Group General hospital — Anshan, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Liaoning Health Industry Group Iron Coal General Hospital — Tieling, Liaoning, China (Not_yet_recruiting)
• The First People's Hospital of Yinchuan — Yinchuan, Ningxia, 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)
• Shandong Second Provincial General Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Qilu, 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 (Not_yet_recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• Tianjin People's Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• Tianjin First Central Hospital — Tianjin, Tianjin, 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)

Study contacts

• Study coordinator: Zheng Liu, Doctor

Conditions Seasonal Allergic Rhinitis