Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis

Launched by SHANGHAI CHIA TAI TIANQING PHARMACEUTICAL TECHNOLOGY DEVELOPMENT CO., LTD. · Jan 2, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment called TQH2722 injection for patients with seasonal allergic rhinitis, a condition that causes allergy symptoms during certain times of the year, usually due to pollen. The trial will involve 168 participants who have not found relief from their allergy symptoms despite using standard treatments like mometasone furoate nasal spray and loratadine. The researchers aim to see how effective and safe TQH2722 is compared to a placebo (a dummy treatment) in helping manage allergy symptoms.

To participate in this trial, individuals need to be between 18 and 75 years old and have been diagnosed with allergic rhinitis according to specific guidelines. They should have experienced uncontrolled allergy symptoms despite previous treatments and must show a positive skin test or blood test for allergens. Participants will receive the TQH2722 injection while continuing their regular allergy treatments and will be monitored for any side effects or changes in their symptoms. It's important for interested individuals to understand the eligibility criteria and to discuss any questions with their healthcare provider before joining the study.

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ALL

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