Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis

Phase 2CompletedNCT07052097

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.136 enrolled

Overview

To evaluate TQC2938 injection in all patients receiving background treatment with azelastine fluticasone nasal spray. The efficacy, safety and immunogenicity of the injection in patients with seasonal allergic rhinitis compared with placebo are expected to include 136 patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Seasonal Allergic Rhinitis

Interventions

TQC2938 injectionDRUG

TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.

TQC2938 PlaceboDRUG

TQC2938 placebo, 4 weeks as a treatment cycle.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 Specific Absorption Rate (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 ≥6; At baseline visit, the morning iTNSS was ≥6 points, and the average score of the past 6 rTNSS was ≥6 points; * 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; * History of active pulmonary tuberculosis within 12 months prior to screening; * 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

Locations (30)

Outcomes

Primary Outcomes

Retrospective nasal symptom score after 2 weeks

Average daily retrospective nasal symptom score (rTNSS) changed from baseline after 2 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 weeks

Secondary Outcomes

Retrospective nasal symptom score after 4 weeks

Mean daily retrospective nasal symptom total score (rTNSS) changes from baseline at 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 4 weeks

Retrospective nasal symptom score at 2-week and 4-week at day time

Mean daily changes in retrospective nasal symptom total score (AM rTNSS) from baseline at 2 weeks and 4 weeks after treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective nasal symptom score at 2-week and 4-week at night time

Mean daily nightly retrospective nasal symptom total score (PM rTNSS) changes from baseline at 2 weeks and 4 weeks after treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous nasal symptom score

Mean change of instantaneous nasal symptom total score (iTNSS) from baseline every morning before treatment for 2 weeks and 4 weeks. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective nasal symptom score-Mean daily rTNSS change

Data from ClinicalTrials.gov

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Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing TongRen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Ganzu Province People's Hospital

Lanzhou, Ganzu, China

Cangzhou central hosipital

Cangzhou, Hebei, China

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

First Affiliated Hospital, Heilongjang University of Chinese Medigine

Harbin, Heilongjang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

People'S Hospital of Zhengzhou

Zhengzhou, Henan, China

...and 20 more locations

Mean daily rTNSS change from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Peak Inspiratory Flow

Mean daily changes in peak inspiratory flow from baseline at 2 weeks and 4 weeks after treatment.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous nasal symptom score

Mean change rate of iTNSS from baseline before treatment at 2 weeks and 4 weeks each morning. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous nasal single symptom score

Mean changes from baseline in daily retrospective nasal symptom scores (runny nose, nasal congestion, nasal itchy, and sneezing) at 2 and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous nasal single symptom score at day time

Mean changes from baseline in scores of individual nasal symptoms (runny nose, nasal congestion, itchy nose, and sneezing) were reviewed daily (AM) at 2 weeks and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous nasal single symptom score at night time

Mean changes from baseline in scores of individual nasal symptoms (runny nose, nasal congestion, nasal itchy and sneezing) at night (PM) after 2 and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective ocular symptom score (rTOSS)

Mean changes in daily retrospective ocular symptom score (rTOSS) from baseline at 2 and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective ocular symptom score (AM rTOSS)

Mean daily changes in retrospective ocular symptom score (AM rTOSS) from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective ocular symptom score (PM rTOSS)

Mean nightly retrospective ocular symptom score (PM rTOSS) changes from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous ocular symptom score (iTOSS)

Mean change of instantaneous ocular symptom total score (iTOSS) from baseline every morning at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective ocular symptom score ( rTOSS)

Mean rate of change in daily rTOSS from baseline at 2 and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Instantaneous ocular symptom score

Mean change rate of iTOSS from baseline before treatment at 2 weeks and 4 weeks each morning. The total score is 0-9 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 4 weeks

Retrospective ocular single symptom score

Average changes in scores of individual ocular symptoms (itchy, tearing, red eyes) at 2 and 4 weeks of treatment compared with baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective ocular single symptom score

Average changes of individual ocular symptom scores (itchy, watery eyes, red eyes) compared with baseline were reviewed daily (AM) at 2 weeks and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Retrospective ocular single symptom score

Average changes of individual ocular symptoms (itchy, watery eyes, red eyes) scores at night (PM) after 2 weeks of treatment and 4 weeks of treatment compared with baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Quality of life questionnaire

Changes in quality of life questionnaire (RQLQ) scores from baseline for patients with allergic rhinitis after 2 weeks and 4 weeks of treatment. The total score is 0-168 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Time of onset

Time frame: Baseline up to 4 weeks

Time to Reach Maximum Plasma Concentration (Tmax)

Curative effect peak time;

Time frame: Baseline up to 4 weeks

Area under the curve

Area under the curve of mean daily rTNSS change from baseline at 2 and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms.

Time frame: Baseline up to 2 and 4 weeks

Severity of nasal symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.)

2 weeks of treatment and 4 weeks of asymptomatic or mild symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.).

Time frame: Baseline up to 2 and 4 weeks

Adverse events and serious adverse events

Incidence and severity of adverse events (AE) and serious adverse events(SAE), and abnormal laboratory test indicators

Time frame: Baseline up to 12 weeks

Blood drug concentration

Blood drug concentration.

Time frame: Week 0,2, 4, 8, 12 before administration

Blood eosinophil (EOS) count at each evaluation visit

Blood eosinophil (EOS) count and percentage at each evaluation visit.

Time frame: Week 0,2, 4, 8, 12 before administration

Change from baseline in serum total immunoglobulin E (IgE) concentration

Change and percentage change from baseline in serum total immunoglobulin E (IgE) concentration.

Time frame: Week 0,2, 4, 8, 12 before administration

The incidence of antidrug antibodies (ADA)

The incidence and titers of antidrug antibodies (ADA) in the test subjects. If a positive result is detected for ADA in the test subjects, then the neutralizing antibody will be tested as well.

Time frame: Week 0,2, 4, 8, 12 before administration

the incidence of neutralizing antibodies (Nab)

The incidence of neutralizing antibodies (Nab). If a positive result is detected for ADA in the test subjects, then the neutralizing antibody will be tested as well.

Time frame: Week 0,2, 4, 8, 12 before administration