Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis

NCT ID: NCT06760182

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-07-01

Brief Summary

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To evaluate TQH2722 injection in all patients receiving background treatment with mometasone furoate nasal spray (MFNS) and loratadine. The efficacy, safety and immunogenicity of the solution in patients with seasonal allergic rhinitis compared with placebo are expected to include 168 patients with confirmed seasonal allergic rhinitis (SAR) who have failed to respond to standard treatments.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TQH2722 injection

Group Type EXPERIMENTAL

TQH2722 injection

Intervention Type DRUG

TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).

TQH2722 Placebo

TQH2722 placebo, 1 weeks as a treatment cycle.

Group Type PLACEBO_COMPARATOR

TQH2722 Placebo

Intervention Type DRUG

Placebo without drug substance.

Interventions

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TQH2722 injection

TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).

Intervention Type DRUG

TQH2722 Placebo

Placebo without drug substance.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Gansu Provincial Hospital

Lanzhou, Gansu, China

Site Status

Cangzhou Central Hospital

Cangzhou, Hebei, China

Site Status

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

The Central Hospital of Wuhan

Wuhan, Hubei, China

Site Status

Union Hospital, Tongji Medical College, Huazhong University of science and technology

Wuhan, Hubei, China

Site Status

Tongji Hospital of Tongji medical college of HUST

Wuhan, Hubei, China

Site Status

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Baotou Central Hospital

Baotou, Inner Mongolia, China

Site Status

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

Site Status

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status

Ansteel Group General hospital

Anshan, Liaoning, China

Site Status

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Liaoning Health Industry Group Iron Coal General Hospital

Tieling, Liaoning, China

Site Status

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

Site Status

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Shandong Second Provincial General Hospital

Jinan, Shandong, China

Site Status

Qilu Hospital of Shandong University

Qilu, Shandong, China

Site Status

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status

Zibo Central Hospital

Zibo, Shandong, China

Site Status

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

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China

Other Identifiers

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TQH2722-II-05

Identifier Type: -

Identifier Source: org_study_id

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