Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis

CTTQ

Status and phase: Enrolling; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: TQC2938 injection; Drug: TQC2938 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07052097

TQC2938-II-02

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

TQC2938 injection

Experimental group

Description:

TQC2938 injection, 4 weeks as a treatment cycle.

Treatment:

Drug: TQC2938 injection

TQC2938 Placebo

Placebo Comparator group

Description:

TQC2938 placebo, 4 weeks as a treatment cycle.

Treatment:

Drug: TQC2938 Placebo