Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.

Last updated: November 19, 2025
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Asthma

Treatment

Placebo

TQC2731 injection

Clinical Study ID

NCT05472324
TQC2731-II-01
  • Ages 18-75
  • All Genders

Study Summary

This is a phase II, multicenter, double-blind, randomized, parallel group, placebo-controlled clinical study to evaluate the effect of three doses of TQC2731 on Annualized Asthma Exacerbation Rates(AAER) in adult subjects with poor control of severe asthma. It is estimated that 220 subjects will be included. The subjects will receive TQC2731 (70 mg Q4w, 210 mg Q4w, 420 mg Q4w) or placebo (Q4w) administered by Subcutaneous (SC) in the ratio of 1:1:1:1.

The study comprised a 5 to 6-week screening period, a 52-week treatment period and a 12-week follow-up period. During the treatment period, the study drug will be administered from day 0 until week 48. The study drug was not administered at the 52nd week.

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

Total Participants: 205
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 23, 2022
Estimated Completion Date:
March 05, 2025

Connect with a study center

  • GUANGZHOU FIRST PEOPLE's HOSPITAL

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • GUANGZHOU FIRST PEOPLE's HOSPITAL

    Guangzhou 1809858, Guangdong 1809935 510180
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

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