Phase
Condition
Asthma
Treatment
Placebo
TQC2731 injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
1 Age. 18-75
2 Documented physician-diagnosed asthma for at least 12 months before visit 1.
3 Subjects who have received a physician-prescribed asthma controller medicationwith medium or high dose inhaled glucocorticosteroid (ICS) for at least 12 monthsbefore visit 1.
4 Documented treatment with a total daily dose of either medium or high dose ICS forat least 3 months before visit 1.
5 At least one additional maintenance asthma controller medication such as Longacting β2 receptor agonist (LABA), leukotriene receptor antagonist (LTRA),theophylline, Long-acting muscarinic antagonists (LAMA), sodium cromoglycate, etc.is required according to standard practice of care and must be documented for atleast 3 months.
6 Morning pre-BD FEV1 <80% predicted normal At visit 2 or visit 2a.
7 Evidence of asthma as documented by either: Documented historical reversibility ofFEV1 ≥12% and ≥200 mL in the previous 12 months before visit 1 OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening Atvisit 2 or visit 2a.
8 Documented history of at least 2 asthma exacerbation events within 12 monthsbefore visit 1.
9 ACQ-6 score ≥1.5 at visit 1
10 Body weight ≥ 40 kg at visit 1.
Exclusion
Exclusion Criteria:
1 Pulmonary disease other than asthma.
2 History of cancer.
3 Current smokers or subjects with smoking history ≥10 pack-years.
4 Hepatitis B, C, human immunodeficiency virus (HIV) or Syphilis.
5 History of anaphylaxis following any biologic therapy.
6 History of chronic alcohol or drug abuse within 12 months.
7 History of a clinically significant infection.
8 Pregnant or breastfeeding.
Study Design
Connect with a study center
GUANGZHOU FIRST PEOPLE's HOSPITAL
Guangzhou, Guangdong 510180
ChinaSite Not Available
GUANGZHOU FIRST PEOPLE's HOSPITAL
Guangzhou 1809858, Guangdong 1809935 510180
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou 1784658, Henan 1808520 450000
ChinaSite Not Available

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