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

NCT05472324 | Completed Phase 2

• 1 other identifier: TQC2731-II-01
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Annual Asthma Exacerbation Rate

  The annual exacerbation rate is based on annualized asthma exacerbation rates reported by the investigator in the electronic case report form(eCRF). The analysis is based on the primary population (Full Analysis Set)

  Baseline up to Study Week 64

Secondary Outcomes (16)

• Change from baseline in forced expiratory volume in first second(FEV1) of Pre-dose and Pre-bronchodilator (Pre-BD).

  Baseline up to Study Week 64

• Mean Change From Baseline in Weekly Rescue Medication Use

  Baseline up to Study Week 64

• Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .

  Baseline up to Study Week 64

• Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) Total Score

  Baseline up to Study Week 64

• Change From Baseline in Asthma Control Questionnaire-6(ACQ-6)

  Baseline up to Study Week 64

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo, subcutaneous administration, 4 weeks as a treatment cycle.

Drug: Placebo

TQC2731 injection 70 mg

EXPERIMENTAL

TQC2731 injection 70 mg, subcutaneous administration, 4 weeks as a treatment cycle.

Drug: TQC2731 injection

TQC2731 injection 210 mg

EXPERIMENTAL

TQC2731 injection 210 mg, subcutaneous administration, 4 weeks as a treatment cycle.

Drug: TQC2731 injection

TQC2731 injection 420 mg

EXPERIMENTAL

TQC2731 injection 420 mg, subcutaneous administration, 4 weeks as a treatment cycle.

Drug: TQC2731 injection

Interventions

TQC2731 injection DRUG

TQC2731 is a humanized monoclonal antibody based on human thymic stromal lymphopoietin (TSLP) sequence.

TQC2731 injection 210 mg; TQC2731 injection 420 mg; TQC2731 injection 70 mg

Placebo DRUG

The drug is a placebo Comparator.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age. 18-75
• Documented physician-diagnosed asthma for at least 12 months before visit 1.
• 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.
• Documented treatment with a total daily dose of either medium or high dose ICS for at least 3 months before visit 1.
• 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.
• Morning pre-BD FEV1 \<80% predicted normal At visit 2 or visit 2a.
• 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.
• Documented history of at least 2 asthma exacerbation events within 12 months before visit 1.
• ACQ-6 score ≥1.5 at visit 1
• Body weight ≥ 40 kg at visit 1.

You may not qualify if:

• Pulmonary disease other than asthma.
• History of cancer.
• Current smokers or subjects with smoking history ≥10 pack-years.
• Hepatitis B, C, human immunodeficiency virus (HIV) or Syphilis.
• History of anaphylaxis following any biologic therapy.
• History of chronic alcohol or drug abuse within 12 months.
• History of a clinically significant infection.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

GUANGZHOU FIRST PEOPLE's HOSPITAL

Guangzhou, Guangdong, 510180, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 25, 2022
• Study Start: September 23, 2022
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-03

Locations

CN (2)