Severe AsthmaPhase 2NCT05472324
Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
A Phase 2 study testing TQC2731 injection in people with Severe Asthma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- TQC2731 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 2 sitesChina
- Study dates
- 23 Sep 2022to 5 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
GUANGZHOU FIRST PEOPLE's HOSPITAL
Guangzhou, Guangdong, 510180
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
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
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
- Being tested
- TQC2731 injection, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC2731 injectionDrug
TQC2731 is a humanized monoclonal antibody based on human thymic stromal lymphopoietin (TSLP) sequence.
PlaceboDrug
The drug is a placebo Comparator.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, subcutaneous administration, 4 weeks as a treatment cycle. Receives: Drug: Placebo |
| TQC2731 injection 70 mg | Experimental | TQC2731 injection 70 mg, subcutaneous administration, 4 weeks as a treatment cycle. Receives: Drug: TQC2731 injection |
| TQC2731 injection 210 mg | Experimental | TQC2731 injection 210 mg, subcutaneous administration, 4 weeks as a treatment cycle. Receives: Drug: TQC2731 injection |
| TQC2731 injection 420 mg | Experimental | TQC2731 injection 420 mg, subcutaneous administration, 4 weeks as a treatment cycle. Receives: Drug: TQC2731 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 64
Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .
Mean change from baseline in FeNO (Ppb)
Measured: Baseline up to Study Week 64
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).
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 52
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.
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 64
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].
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 64
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.
Measured: Baseline up to Study Week 64
Change From Baseline in Blood Eosinophils .
Mean change from baseline in Blood Eosinophils measured at site
Measured: Baseline up to Study Week 64
Change From Baseline in Total Serum immunoglobulin E(IgE).
Mean change from baseline in Total Serum IgE measured at site
Measured: Baseline up to Study Week 64
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].
Measured: Baseline up to Study Week 64
abnormal laboratory test indicators
Researchers make medical judgment according to the severity of abnormal indicators and the relevant conditions of patients' diseases.
Measured: Baseline up to Study Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start23 Sep 2022
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472324
- Sponsor's protocol ID
- TQC2731-II-01
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05472324
- Acronym / sponsor ID
- TQC2731-II-01
- Conditions
- Severe Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, subcutaneous administration, 4 weeks as a treatment cycle. |
| TQC2731 injection 70 mg | Experimental | Drug: TQC2731 injectionTQC2731 injection 70 mg, subcutaneous administration, 4 weeks as a treatment cycle. |
| TQC2731 injection 210 mg | Experimental | Drug: TQC2731 injectionTQC2731 injection 210 mg, subcutaneous administration, 4 weeks as a treatment cycle. |
| TQC2731 injection 420 mg | Experimental | Drug: TQC2731 injectionTQC2731 injection 420 mg, subcutaneous administration, 4 weeks as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC2731 injectionTQC2731 is a humanized monoclonal antibody based on human thymic stromal lymphopoietin (TSLP) sequence. | Drug | TQC2731 injection 210 mg, TQC2731 injection 420 mg, TQC2731 injection 70 mg |
| PlaceboThe drug is a placebo Comparator. | Drug | Placebo |
Primary outcome
Annual Asthma Exacerbation Rate
Time frame: Baseline up to Study Week 64
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)
16 secondary outcomes
Change from baseline in forced expiratory volume in first second(FEV1) of Pre-dose and Pre-bronchodilator (Pre-BD).
Time frame: Baseline up to Study Week 64
Mean Change From Baseline in Weekly Rescue Medication Use
Time frame: Baseline up to Study Week 64
Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .
Time frame: Baseline up to Study Week 64
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) Total Score
Time frame: Baseline up to Study Week 64
Change From Baseline in Asthma Control Questionnaire-6(ACQ-6)
Time frame: Baseline up to Study Week 64
Mean Change From Baseline in Asthma Symptom Diary
Time frame: Baseline up to Study Week 52
Change From Baseline in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) VAS
Time frame: Baseline up to Study Week 64
Time to First Asthma Exacerbation
Time frame: Baseline up to Study Week 64
Proportion of subjects with at least one asthma exacerbation
Time frame: Baseline up to Study Week 64
Incidence and severity of adverse events (AE)
Time frame: Baseline up to Study Week 64
Mean Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) (Weekly Means).
Time frame: Baseline up to Study Week 64
Mean Change From Baseline in Night Time Awakenings (Weekly Means)
Time frame: Baseline up to Study Week 64
Change From Baseline in Blood Eosinophils .
Time frame: Baseline up to Study Week 64
Change From Baseline in Total Serum immunoglobulin E(IgE).
Time frame: Baseline up to Study Week 64
Incidence and severity of serious adverse events (SAE)
Time frame: Baseline up to Study Week 64
abnormal laboratory test indicators
Time frame: Baseline up to Study Week 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Related trials for Severe Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
Asthma
RecruitingPhase 3
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
Severe Asthma
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQC2731 injection in people with Severe Asthma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Asthma Exacerbation Rate (time frame: Baseline up to Study Week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.