Clinical trial NCT06760182: Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-06
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Retrospective nasal symptom score after treatment for 2 weeks
timeFrame: Baseline up to 2 weeks
Secondary outcomes:
measure: Retrospective nasal symptom score after treatment for 4 weeks
timeFrame: Baseline up to 4 weeks
measure: Mean daily changes in retrospective nasal symptom total score
timeFrame: Baseline up to 2 and 4 weeks
measure: Mean daily nightly retrospective nasal symptom total score
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous nasal symptom score: Mean change of instantaneous nasal symptom total score (iTNSS) from baseline
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous nasal symptom score: Mean daily rTNSS change from baseline
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous nasal symptom score: Mean change rate of iTNSS from baseline
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous nasal single symptom score: Mean changes from baseline in daily retrospective nasal symptom scores
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous nasal single symptom score: Mean changes from baseline in scores of individual nasal symptoms during the day
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous nasal single symptom score: Mean changes from baseline in scores of individual nasal symptoms at night
timeFrame: Baseline up to 2 and 4 weeks
measure: Retrospective ocular symptom score: Mean changes in daily retrospective ocular symptom score
timeFrame: Baseline up to 2 and 4 weeks
measure: Retrospective ocular symptom score: Mean changes in retrospective ocular symptom score during the day
timeFrame: Baseline up to 2 and 4 weeks
measure: Retrospective ocular symptom score: Mean retrospective ocular symptom score at night
timeFrame: Baseline up to 2 and 4 weeks
measure: Retrospective ocular symptom score: Mean change of instantaneous ocular symptom total score
timeFrame: Baseline up to 2 and 4 weeks
measure: Retrospective ocular symptom score: Mean rate of change in daily rTOSS
timeFrame: Baseline up to 2 and 4 weeks
measure: Retrospective nasal symptom score: Average daily retrospective nasal symptom score
timeFrame: Baseline up to 4 weeks
measure: Retrospective ocular symptom score: Mean change rate of iTOSS each morning
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous ocular single symptom score: Average changes in scores of individual ocular symptoms
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous ocular single symptom score: Average changes of individual ocular symptom scores during the day
timeFrame: Baseline up to 2 and 4 weeks
measure: Instantaneous ocular single symptom score: Average changes of individual ocular symptoms at night
timeFrame: Baseline up to 2 and 4 weeks
measure: Quality of life questionnaire
timeFrame: Baseline up to 2 and 4 weeks
measure: Time of onset
timeFrame: Baseline up to 4 weeks
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: Baseline up to 4 weeks
measure: Area under the curve
timeFrame: Baseline up to 2 and 4 weeks
measure: Number of days with no or mild symptoms of Allergic rhinitis symptoms
timeFrame: Baseline up to 2 and 4 weeks
measure: Adverse event rate
timeFrame: Baseline up to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of science and technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Tongji medical college of HUST
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Anshan
country: China
facility: Ansteel Group General hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Tieling
country: China
facility: Liaoning Health Industry Group Iron Coal General Hospital
state: Liaoning
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Second Provincial General Hospital
state: Shandong
city: Qilu
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References: