TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Phase 3

Recruiting

• Conditions: Asthma
• Interventions: Drug: TQC2731 injection; Drug: Placebo

• Registration Number: NCT06829784
• Lead Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study Start: 2025-03-21
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 660

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQC2731 injection	TQC2731 injection	TQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48.
Placebo	Placebo	Placebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
Changes in total serum IgE	From baseline to week 52	Change from baseline in total serum IgE at week 52.
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).

Trial Locations

Locations (74)

Weifang NO.2 People's Hospital; 🇨🇳 Weifang, Shandong, China

Fudan University Affiliated Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Wusong Central Hospital, Baoshan District, Shanghai; 🇨🇳 Shanghai, Shanghai, China

The People's Hospital of Bozhou; 🇨🇳 Bozhou, Anhui, China

Anhui Chest Hoispital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

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