Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called TQC2938 to see if it helps people with seasonal allergic rhinitis, which is a common allergy that causes symptoms like sneezing, runny or stuffy nose, especially during certain times of the year when pollen is high. Everyone in the study will continue using their usual nasal spray medicine (azelastine and fluticasone) while trying this new injection or a placebo (a harmless shot with no active medicine) to compare the effects. The trial aims to include about 136 adults aged 18 to 75 who have confirmed seasonal allergies and whose symptoms have not been well controlled by their current treatments.

If you join this study, you should have had positive allergy tests and experience allergy symptoms during pollen season that are bothersome despite treatment. You will be asked to receive the injection and continue your regular nasal spray, and the researchers will check how well you respond, how safe the injection is, and if your immune system reacts to it. The study is not yet recruiting participants, and certain health conditions or treatments, like recent nasal surgery or serious immune problems, may prevent someone from joining. Participants will need to agree to use effective contraception during and after the study if applicable. This trial hopes to find better ways to manage seasonal allergies for those who don’t get enough relief from current medicines.

Gender

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 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