Adults with severe, poorly controlled asthma
Conditions
Interventions
Group 1:QX008N injection
Group 2:Placebo
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the experiment, voluntarily acts as the subject and signs the informed consent; 2. The age at the time of signing the informed consent is 18-75 years old (including the threshold value), no gender limit; 3. Weight >=40kg; 4. The subject has been diagnosed with asthma for at least 1 year; 5. At least 6 months of medium to high dose of inhaled corticosteroids (ICS) before screening, and 3 months of stable use before randomization; 6. Combined with at least one other asthma control drug, such as LABA, LTRA, etc., and stable use for 3 months before randomization; 7. 40%=12% and >=200 mL were recorded within 12 months before randomization; 9. ACQ-6 score >=1.5 before randomization; 10. Agree not to have a family plan during the trial period and for six months after the trial and voluntarily use effective contraceptive methods; 11. Subjects were able to communicate well with researchers and complete the study according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Previous recipients of the same target (TSLP) drugs; 2. Smoking or quitting less than 6 months at the time of screening, or smoking quantity >=10 packs of years; 3. Combined with immunodeficiency diseases; 4. Evidence that the subject has severe, progressive, uncontrolled or uncontrollable cardiovascular disease, neuromuscular disease, hematological disease, respiratory disease other than asthma, digestive disease, urinary disease, endocrine or metabolic disease, neurological or psychiatric disease, etc.; 5. The presence of parasitic infection within the first 6 months of randomization; 6. Known infection (including chronic or local infection) within 7 days prior to screening, known history of repeated infection (>=3 times/year) and underlying disease prone to infection, disseminated herpes simplex infection or recurrent (>1 time) or disseminated herpes zoster, and history of opportunistic infection; 7. A history of malignancy or malignancy (squamous cell carcinoma of the skin that has been successfully treated without evidence of recurrence and metastasis within 5 years, except basal cell carcinoma or local cervical carcinoma in situ); 8. People with a known history of active TB, or those infected with active or latent TB at the time of screening; 9. Use or have used any of the drugs prohibited in this study within the following time periods: (1) Those who have received live vaccine, live attenuated vaccine, inactivated vaccine, adenovirus vector vaccine, or plan to receive live (attenuated) vaccine during the course of the trial within 1 month prior to screening; (2) LAMA within 15 days prior to screening; (3) Use mesulast (T2 cytokine inhibitor) within 15 days prior to screening; Theophylline antiasthmatic drugs were used within 15 days prior to screening; (4) Short-acting anticholinergic drug SAMA (such as ipratropium bromide) was used in screening; (5) Received the following medications in the 12 weeks prior to randomization: systemic immunosuppressants/immunomodulatory drugs (e.g. Methotrexate, cyclosporin, etc.), except OCS for asthma/acute exacerbations; (6) Received immunoglobulin or other blood products within 3 months prior to screening; (7) People in clinical trials of any drug or medical device within 3 months or 5 half-lives, whichever is greater, prior to screening; (8) Use of any marketed (e.g. omalizumab, mepolizumab, reslizumab) or upcoming marketed or investigational biologics within 3 months or 5 half-life periods prior to screening, whichever is longer; (9) Use of any prescription drugs or Chinese herbs within 4 weeks before screening; (10) Initiation of allergen immunotherapy within 2 months prior to screening or planned during the study; 10. Laboratory test values meet any of the following criteria (patients whose first test exceeds the prescribed value range can be reexamined for a second time, and the results of the second test can be included in the study after the investigator determines that there is no abnormality) : (1) Hemoglobin 1.2 times ULN; 11. Two pairs and half of hepatitis B were detected as HBsAg positive during screening (if HBsAg negative, but anti-HBC positive and anti-HBs negative at the same time, HBV-DN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in forced expiratory volume in one second (FEV1) before bronchodilator administration (Pre-BD) at week 12 from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Forced expiratory volume (FEV1) at 1 second before administration and before bronchodilator (Pre-BD) was changed from baseline at each evaluation time point;The changes of peak expiratory flow (PEF), fractional exhaled nitric oxide (FeNO), blood eosinophil count (EOS) and serum immunoglobulin (IgE) at each evaluation time point were compared with baseline;Change in Asthma Control Questionnaire-6 (ACQ-6) at each evaluation time point from baseline;Number of acute asthma attacks from baseline to D127 versus placebo group;Safety;Immunogenicity;Pharmacokinetic; | — |
Countries
China
Contacts
Public ContactJin Meiling
Zhongshan Hospital of Fudan University
Outcome results
None listed