Back to resultsEvaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
Primary Purpose
Severe Asthma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQC2731 injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Severe Asthma
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.
Sites / Locations
- GUANGZHOU FIRST PEOPLE's HOSPITALRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
TQC2731 injection 70 mg
TQC2731 injection 210 mg
TQC2731 injection 420 mg
Arm Description
Placebo, subcutaneous administration, 4 weeks as a treatment cycle.
TQC2731 injection 70 mg, subcutaneous administration, 4 weeks as a treatment cycle.
TQC2731 injection 210 mg, subcutaneous administration, 4 weeks as a treatment cycle.
TQC2731 injection 420 mg, subcutaneous administration, 4 weeks as a treatment cycle.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change from baseline in forced expiratory volume in first second(FEV1) of Pre-dose and Pre-bronchodilator (Pre-BD).
FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Mean Change From Baseline in Weekly Rescue Medication Use
Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.
Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .
Mean change from baseline in FeNO (Ppb)
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) Total Score
The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Change From Baseline in Asthma Control Questionnaire-6(ACQ-6)
The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Mean Change From Baseline in Asthma Symptom Diary
Mean change from baseline at Week 52 in Asthma Symptom Diary (ASD). The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.
Change From Baseline in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) VAS
Mean change from baseline in EQ-5D-5L VAS. EQ-5D-5L visual analogue scale (VAS) allows subjects to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. EQ-5D-5L VAS.
Time to First Asthma Exacerbation
Time to first occurrence of asthma exacerbation post-randomisation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF.
Proportion of subjects with at least one asthma exacerbation
Proportion of subjects with at least one asthma exacerbation as recorded by the investigator in the Case Report Form(CRF). This is presented as proportion of subjects with at least one asthma exacerbation.
Incidence and severity of adverse events (AE)
The incidence of adverse events in subjects recorded by the investigator in CRF.
The evaluation criteria for the severity of adverse events were carried out in accordance with [NCI- CTCv5.0].
Mean Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) (Weekly Means).
Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.
Mean Change From Baseline in Night Time Awakenings (Weekly Means)
Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.
Change From Baseline in Blood Eosinophils .
Mean change from baseline in Blood Eosinophils measured at site
Change From Baseline in Total Serum immunoglobulin E(IgE).
Mean change from baseline in Total Serum IgE measured at site
Incidence and severity of serious adverse events (SAE)
The incidence of serious adverse events in subjects recorded by the investigator in CRF.
The evaluation criteria for the severity of serious adverse events were carried out in accordance with [NCI-CTCv5.0].
abnormal laboratory test indicators
Researchers make medical judgment according to the severity of abnormal indicators and the relevant conditions of patients' diseases.
Full Information
NCT ID
NCT05472324
First Posted
June 9, 2022
Last Updated
November 1, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05472324
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, subcutaneous administration, 4 weeks as a treatment cycle.
Arm Title
TQC2731 injection 70 mg
Arm Type
Experimental
Arm Description
TQC2731 injection 70 mg, subcutaneous administration, 4 weeks as a treatment cycle.
Arm Title
TQC2731 injection 210 mg
Arm Type
Experimental
Arm Description
TQC2731 injection 210 mg, subcutaneous administration, 4 weeks as a treatment cycle.
Arm Title
TQC2731 injection 420 mg
Arm Type
Experimental
Arm Description
TQC2731 injection 420 mg, subcutaneous administration, 4 weeks as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
TQC2731 injection
Intervention Description
TQC2731 is a humanized monoclonal antibody based on human thymic stromal lymphopoietin (TSLP) sequence.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The drug is a placebo Comparator.
Primary Outcome Measure Information:
Title
Annual Asthma Exacerbation Rate
Description
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)
Time Frame
Baseline up to Study Week 64
Secondary Outcome Measure Information:
Title
Change from baseline in forced expiratory volume in first second(FEV1) of Pre-dose and Pre-bronchodilator (Pre-BD).
Description
FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time Frame
Baseline up to Study Week 64
Title
Mean Change From Baseline in Weekly Rescue Medication Use
Description
Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.
Time Frame
Baseline up to Study Week 64
Title
Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .
Description
Mean change from baseline in FeNO (Ppb)
Time Frame
Baseline up to Study Week 64
Title
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) Total Score
Description
The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Time Frame
Baseline up to Study Week 64
Title
Change From Baseline in Asthma Control Questionnaire-6(ACQ-6)
Description
The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Time Frame
Baseline up to Study Week 64
Title
Mean Change From Baseline in Asthma Symptom Diary
Description
Mean change from baseline at Week 52 in Asthma Symptom Diary (ASD). The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.
Time Frame
Baseline up to Study Week 52
Title
Change From Baseline in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) VAS
Description
Mean change from baseline in EQ-5D-5L VAS. EQ-5D-5L visual analogue scale (VAS) allows subjects to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. EQ-5D-5L VAS.
Time Frame
Baseline up to Study Week 64
Title
Time to First Asthma Exacerbation
Description
Time to first occurrence of asthma exacerbation post-randomisation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF.
Time Frame
Baseline up to Study Week 64
Title
Proportion of subjects with at least one asthma exacerbation
Description
Proportion of subjects with at least one asthma exacerbation as recorded by the investigator in the Case Report Form(CRF). This is presented as proportion of subjects with at least one asthma exacerbation.
Time Frame
Baseline up to Study Week 64
Title
Incidence and severity of adverse events (AE)
Description
The incidence of adverse events in subjects recorded by the investigator in CRF.
The evaluation criteria for the severity of adverse events were carried out in accordance with [NCI- CTCv5.0].
Time Frame
Baseline up to Study Week 64
Title
Mean Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) (Weekly Means).
Description
Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.
Time Frame
Baseline up to Study Week 64
Title
Mean Change From Baseline in Night Time Awakenings (Weekly Means)
Description
Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.
Time Frame
Baseline up to Study Week 64
Title
Change From Baseline in Blood Eosinophils .
Description
Mean change from baseline in Blood Eosinophils measured at site
Time Frame
Baseline up to Study Week 64
Title
Change From Baseline in Total Serum immunoglobulin E(IgE).
Description
Mean change from baseline in Total Serum IgE measured at site
Time Frame
Baseline up to Study Week 64
Title
Incidence and severity of serious adverse events (SAE)
Description
The incidence of serious adverse events in subjects recorded by the investigator in CRF.
The evaluation criteria for the severity of serious adverse events were carried out in accordance with [NCI-CTCv5.0].
Time Frame
Baseline up to Study Week 64
Title
abnormal laboratory test indicators
Description
Researchers make medical judgment according to the severity of abnormal indicators and the relevant conditions of patients' diseases.
Time Frame
Baseline up to Study Week 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinping Zheng, Doctor
Phone
18928868238
Email
jpzhenggy@163.com
Facility Information:
Facility Name
GUANGZHOU FIRST PEOPLE's HOSPITAL
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiantuo Zhang, Doctor
Phone
18922102729
Email
zhtituli@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Cheng, Doctor
Phone
18638027777
Email
chengzhehi@126.com
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
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