Asthma
Conditions
Brief summary
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 trial participants are expected to be enrolled, with trial participants randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.
Interventions
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.
DRUGPlacebo
Placebo without drug substance.
Sponsors
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized incidence of asthma exacerbations | From the first day of dosing to the completion of 52 weeks of treatment | Annualized incidence of asthma exacerbations (AAER) during the 52-week treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total score of standardized asthma quality of life questionnaire | From baseline to week 52 | Change from baseline in standardized asthma quality of life questionnaire (AQLQ(S)+12) total score at week 52. Scores above 5 points indicate a relatively good quality of life, while scores below 3 points suggest a relatively poor quality of life. |
| Change in Asthma Control Questionnaire-6 (ACQ-6) score | From baseline to week 52 | Mean change from baseline in weekly mean asthma symptom diary score at week 52, , The higher the score, the more severe the asthma symptoms. |
| Mean change in weekly mean asthma symptom diary score | From baseline to week 52 | Mean change from baseline in weekly mean asthma symptom diary score at week 52 |
| Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score | From baseline to week 52 | Change from baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score at Week 52, a higher score indicates a better quality of life. |
| Change in mean rescue medication use, average peak expiratory flow rate (PEF) in the morning and night | From baseline to week 52 | Change from baseline in the average weekly dose of rescue medication and the average peak expiratory flow rate (PEF) per week in the morning and night, respectively |
| Changes in exhaled nitric oxide Fractional exhaled nitric oxide (FENO) (ppb), peripheral blood eosinophils, total serum Immunoglobulin E (IgE). | From baseline to week 52 | Change from baseline in exhaled nitric oxide FENO (ppb) at week 52. |
| Changes in peripheral blood eosinophils | From baseline to week 52 | Change from baseline in peripheral blood eosinophils at week 52. |
| The change in forced expiratory volume in 1 second (FEV1) | Week 52 before dosing and before the use of bronchodilators (pre-Bronchodilator (pre-BD) administration) | At Week 52, the change from baseline in forced expiratory volume in 1 second (FEV1) prior to dosing and before the use of a bronchodilator (pre-BD administration). |
| Time to first asthma exacerbation | Baseline to week 64 | Time to first asthma exacerbation |
| Proportion of subjects with ≥1 asthma exacerbation | Baseline to week 64 | Proportion of subjects with ≥1 asthma exacerbation |
| Number of days of glucocorticoid use due to acute exacerbations | Baseline to week 64 | Number of days of glucocorticoid use due to acute exacerbations |
| Average amount of hormone used per acute exacerbation (prednisone equivalent) | Baseline to week 64 | Average amount of hormone used per acute exacerbation (prednisone equivalent) |
| Incidence of anti-drug antibodies (ADAs) in subjects | Baseline to week 64 | Immunogenicity: Incidence of anti-drug antibodies (ADAs) in subjects and their titers. |
| Incidence of neutralizing antibodies(NAB) in subjects | Baseline to week 64 | Immunogenicity: Incidence of neutralizing antibodies (NAB). |
| Changes in total serum IgE | From baseline to week 52 | Change from baseline in total serum IgE at week 52. |
Countries
China
Contacts
CONTACTJinping Zheng, Doctor
CONTACTQingling Zhang, Doctor
Outcome results
None listed