TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injections in Patients With Poorly Controlled Severe Asthma

Обзор

This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.

Вмешательства

• Препарат TQC2731 injection
  TQC2731 injection can specifically bind to the Thymic Stromal Lymphopoietin (TSLP) protein, blocking TSLP-dependent downstream signaling expression in engineered cells and inhibiting the production of inflammatory cytokines.
• Препарат Placebo
  Placebo without drug substance.

Первичные конечные точки

• Annualized incidence of asthma exacerbations [Срок оценки: From the first day of dosing to the completion of 52 weeks of treatment]

Вторичные конечные точки (12)

• The change in forced expiratory volume in 1 second (FEV1) [Срок оценки: Week 52 before dosing and before the use of bronchodilators (pre-Bronchodilator (pre-BD) administration)]
• Change in total score of standardized asthma quality of life questionnaire [Срок оценки: From baseline to week 52]
• Change in Asthma Control Questionnaire-6 (ACQ-6) score [Срок оценки: From baseline to week 52]
• Mean change in weekly mean asthma symptom diary score [Срок оценки: From baseline to week 52]
• Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score [Срок оценки: From baseline to week 52]
• Change in mean rescue medication use, average peak expiratory flow rate (PEF) in the morning and night [Срок оценки: From baseline to week 52]
• Changes in exhaled nitric oxide Fractional exhaled nitric oxide (FENO) (ppb), peripheral blood eosinophils, total serum Immunoglobulin E (IgE). [Срок оценки: From baseline to week 52]
• Changes in peripheral blood eosinophils [Срок оценки: From baseline to week 52]
• Changes in total serum IgE [Срок оценки: From baseline to week 52]
• Time to first asthma exacerbation [Срок оценки: Baseline to week 64]
• Proportion of subjects with ≥1 asthma exacerbation [Срок оценки: Baseline to week 64]
• Number of days of glucocorticoid use due to acute exacerbations [Срок оценки: Baseline to week 64]

Критерии участия

Критерии включения

• Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial;
• Age 18 \~ 75 years old, gender is not limited;
• Documented physician diagnosis of asthma at least 12 months prior to Visit 1;
• Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1;
• There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1;
• There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment.
• Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed.

Критерии исключения

• Have a clinically significant lung disease other than asthma；
• Pre-existing autoimmune disease;
• A history of known or suspected immunosuppression, including a history of invasive opportunistic infections;
• Any disease that has not been determined to be stable by the investigator；
• Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study.
• Current smoker or smoking history ≥10 pack-years (former smokers with smoking history <10 pack-years had quit smoking less than 6 months before interview 1);
• Other factors determined by the investigator that subjects were not suitable to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 101 центр

• The People's Hospital of Bozhou — Бочжоу
• Anhui Chest Hoispital — Хэфэй
• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Lu'an People's Hospital of Anhui Province — Lu'an
• Tongling People's Hospital — Tongling
• Peking University First Hospital — Пекин
• Beijing No.6 Hospital — Пекин
• The First Affiliated Hospital of Xiamen University — Xiamen
• … и ещё 93 центра

Идентификаторы

NCT: NCT06829784 · TQC2731-III-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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