Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis (NCT07052097) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis
China136 participantsStarted 2025-07-31
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 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 compl…
What they're measuring
1
Retrospective nasal symptom score after 2 weeks
Timeframe: Baseline up to 2 weeks
Trial details
NCT IDNCT07052097
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.