Clinical trial NCT05472324: Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Severe Asthma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

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.

Primary outcomes:
measure: Annual Asthma Exacerbation Rate
timeFrame: Baseline up to Study Week 64
Secondary outcomes:
measure: Change from baseline in forced expiratory volume in first second(FEV1) of Pre-dose and Pre-bronchodilator (Pre-BD).
timeFrame: Baseline up to Study Week 64
measure: Mean Change From Baseline in Weekly Rescue Medication Use
timeFrame: Baseline up to Study Week 64
measure: Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .
timeFrame: Baseline up to Study Week 64
measure: Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) Total Score
timeFrame: Baseline up to Study Week 64
measure: Change From Baseline in Asthma Control Questionnaire-6(ACQ-6)
timeFrame: Baseline up to Study Week 64
measure: Mean Change From Baseline in Asthma Symptom Diary
timeFrame: Baseline up to Study Week 52
measure: Change From Baseline in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) VAS
timeFrame: Baseline up to Study Week 64
measure: Time to First Asthma Exacerbation
timeFrame: Baseline up to Study Week 64
measure: Proportion of subjects with at least one asthma exacerbation
timeFrame: Baseline up to Study Week 64
measure: Incidence and severity of adverse events (AE)
timeFrame: Baseline up to Study Week 64
measure: Mean Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) (Weekly Means).
timeFrame: Baseline up to Study Week 64
measure: Mean Change From Baseline in Night Time Awakenings (Weekly Means)
timeFrame: Baseline up to Study Week 64
measure: Change From Baseline in Blood Eosinophils .
timeFrame: Baseline up to Study Week 64
measure: Change From Baseline in Total Serum immunoglobulin E(IgE).
timeFrame: Baseline up to Study Week 64
measure: Incidence and severity of serious adverse events (SAE)
timeFrame: Baseline up to Study Week 64
measure: abnormal laboratory test indicators
timeFrame: Baseline up to Study Week 64
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GUANGZHOU FIRST PEOPLE's HOSPITAL
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References: