NCT05472324CompletedPhase 2
Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
A Multicenter,Randomized,Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Poorly Controlled Severe Asthma
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 9 Jun 2022
- Start date
- 23 Sept 2022
- Primary completion date
- 5 Mar 2025
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Diseases
- Asthma
- NCT number
- NCT05472324
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 205
- From 23 Sept 2022 to the primary completion date, 5 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1 Pulmonary disease other than asthma.
- 2 History of cancer.
- 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.
Other
- 3 Current smokers or subjects with smoking history ≥10 pack-years.
- 8 Pregnant or breastfeeding.
Who the study is looking for
- 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 medication with medium or high dose inhaled glucocorticosteroid (ICS) for at least 12 months before visit 1.
- 4 Documented treatment with a total daily dose of either medium or high dose ICS for at least 3 months before visit 1.
- 5 At least one additional maintenance asthma controller medication such as Long acting 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 at least 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 of FEV1 ≥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 At visit 2 or visit 2a.
- 8 Documented history of at least 2 asthma exacerbation events within 12 months before visit 1.
- 9 ACQ-6 score ≥1.5 at visit 1
- 10 Body weight ≥ 40 kg at visit 1.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.