Clinical Trials List
Protocol NumberD5180C00007
2018-02-01 - 2021-06-30
Phase III
Terminated4
ICD-10J45.901
Unspecified asthma with (acute) exacerbation
ICD-10J45.998
Other asthma
ICD-10J45
Asthma
ICD-9493.92
Asthma, unspecified, with acute exacerbation
A multicenter, randomized, double-blind, placebo-controlled, parallel-grouped Phase III trial to evaluate the efficacy and safety of Tezepelumab in adults and adolescents with poorly controlled severe asthma
-
Trial Applicant
-
Sponsor
AstraZeneca
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 廖偉志 Division of Thoracic Medicine
- 陳韋成 Division of Thoracic Medicine
- 梁信杰 Division of Thoracic Medicine
- 沈宜成 Division of Thoracic Medicine
- Wei-Chun Chen Division of Thoracic Medicine
- Zhi-Yu Chen Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
- Chia-Hsiang Li Division of Thoracic Medicine
- Chih-Yen Tu Division of Thoracic Medicine
- Bing-Ru Wu Division of Thoracic Medicine
- Yu-Chao Lin Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Xin-Min Liao Division of Thoracic Medicine
- 陳炯睿 Division of Thoracic Medicine
- Seu-Chun Yang Division of Thoracic Medicine
- Po-Lan Su Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ming-Ju Tsai Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- Jen-Yu Hung Division of Thoracic Medicine
- jong rung Tsai Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Kuan-Yuan Chen Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
- Ching-Shan Luo Division of Thoracic Medicine
- Tzu-Tao Chen Division of Thoracic Medicine
- Chien-Hua Tseng Division of Thoracic Medicine
- Wen-Te Liu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
As an additional maintenance treatment for patients over 12 years old with severe asthma
Objectives
main purpose:
-To evaluate the efficacy of subcutaneously injecting 210 mg of tezepelumab every 4 weeks compared with placebo on the worsening of asthma in adult and adolescent subjects with poorly controlled severe asthma
Important secondary purpose:
-To evaluate the effect of subcutaneous injection of 210 mg of tezepelumab on lung function compared to placebo every 4 weeks
-To evaluate the effect of 210 mg of tezepelumab subcutaneously on the health status/health-related quality of life compared to placebo every 4 weeks
-To evaluate the effect of subcutaneous injection of 210 mg of tezepelumab on asthma, compared with placebo, every 4 weeks
-To evaluate the effect of subcutaneous injection of 210 mg of tezepelumab on asthma symptoms compared to placebo every 4 weeks
Other secondary purposes:
-To evaluate the impact of 210 mg of tezepelumab subcutaneously on other assessment indicators related to asthma exacerbation once every 4 weeks
-To evaluate the effect of 210 mg of tezepelumab subcutaneously on biomarkers every 4 weeks
-To evaluate the effect of 210 mg of tezepelumab subcutaneously on other asthma control indicators every 4 weeks
-Assessed once every 4 weeks, subcutaneous injection of 210 mg of tezepelumab, compared with placebo, has a better use of health resources
Test Drug
Tezepelumab
Active Ingredient
Tezepelumab
Dosage Form
IV
Dosage
210
Endpoints
1. Main evaluation indicators:
- Main evaluation index: Annual asthma exacerbation rate (AAER)
Main outcome measure: AAER ratio compared to placebo in 52 weeks
2. Important and secondary evaluation indicators:
-Important secondary indicators: Change of forced expiratory volume (FEV1) in the first second before medication/before bronchodilator (before BD) since the reference point
Important outcome measure: mean difference compared to placebo at week 52
-Important and secondary indicators: the total score of the standardized asthma quality of life questionnaire (AQLQ(S) + 12) applicable to 12 years old and above since the benchmark
Variety
Important outcome measure: mean difference compared to placebo at week 52
-Important secondary indicators: Asthma Control Questionnaire 6 (ACQ-6) score changes since the benchmark
Important outcome measure: mean difference compared to placebo at week 52
- Important secondary indicator: Change in the weekly average of the daily asthma symptom log scores since the reference point Important outcome measurement: Week 52
Average difference compared to placebo
3. Other secondary evaluation indicators:
- Outcome variable: Time to first asthma worsening
Outcome measurement: risk of worsening asthma compared to placebo in 52 weeks
-Outcome variable: Proportion of subjects with worsening asthma≥1
Outcome measurement: the difference in proportion compared to placebo at week 52
- Outcome variable: Annual rate of deterioration related to emergency department, emergency care, or hospitalization
Outcome measurement: percentage of annual deterioration rate compared to placebo within 52 weeks
-Outcome variables: changes in the following items since the reference point
- Expiratory Nitric Oxide Concentration (FENO; ppb)
-Periphe-Total serum IgE concentration
Outcome measurement: mean difference compared to placebo at week 52
-Outcome variables: Changes in the following items since the reference point
-Weekly average of emergency medicine usage
-Weekly average of morning and evening peak expiratory flow rate (PEF)
-Weekly average number of night wakefulness
Outcome measurement: mean difference compared to placebo at week 52
-Result variable:
-Use of specific resources for asthma (for example: unscheduled doctor visits, unscheduled doctor phone calls, use of other asthma medications)
-Work Productivity and Activity Impairment (WPAI + CIQ) questionnaire and academic impairment questionnaire scores
-Result measurement:
-Difference in utilization of specific resources for asthma compared with placebo in 52 weeks
-Difference in WPAI + CIQ scores compared to placebo at week 52
-PK: Serum trough concentration
Immunogenicity: incidence of anti-drug antibodies
-Outcome variable: European Quality of Life-5-Oriented 5-Level Daily Life Questionnaire (EQ-5D-5L) score
Outcome measurement: mean difference compared to placebo at week 52
-Outcome variable: the patient's overall impression of the change/severity (PGI-C, PGI-S) and the clinician's overall impression of the change
(CGI-C)
Outcome measurement: response ratio at week 52
4. Safety assessment indicators:
-Adverse Event/Serious Adverse Event
-vital signs
-Clinical chemistry/hematology/urinalysis parameters
-Digital ECG
5. Exploratory evaluation indicators:
-Serum biomarkers, which may include but are not limited to TSLP, IL-33 and TARC
-Specific allergens IgE, total IgE, IgA, IgG and IgM
-Biomarker Transcriptome: RNA Seq and RNA Microarray Analysis
-Selective pharmacogenomic biomarkers: SNP, epigenetic and microbial analysis
-List Th1, Th2, and Th17 cells in whole blood by flow cytometry
-Home FENO for a subgroup of subjects
-FEV1 after BD and forced expiratory flow rate of 20-75% of vital capacity (FEF25-75%)
-FENO, pre-BD FEV1, ACQ-6, asthma symptoms, and changes in emergency medication usage since the baseline
-Changes in sinus-specific HRQoL in patients with nasal polyps at week 58
-Changes in the scores of the St. George's Respiratory Scale (SGRQ) since the reference point
-The incidence of CompEx compared to placebo in 52 weeks. For related definitions, please refer to section 8.1.5 of the plan.
- Main evaluation index: Annual asthma exacerbation rate (AAER)
Main outcome measure: AAER ratio compared to placebo in 52 weeks
2. Important and secondary evaluation indicators:
-Important secondary indicators: Change of forced expiratory volume (FEV1) in the first second before medication/before bronchodilator (before BD) since the reference point
Important outcome measure: mean difference compared to placebo at week 52
-Important and secondary indicators: the total score of the standardized asthma quality of life questionnaire (AQLQ(S) + 12) applicable to 12 years old and above since the benchmark
Variety
Important outcome measure: mean difference compared to placebo at week 52
-Important secondary indicators: Asthma Control Questionnaire 6 (ACQ-6) score changes since the benchmark
Important outcome measure: mean difference compared to placebo at week 52
- Important secondary indicator: Change in the weekly average of the daily asthma symptom log scores since the reference point Important outcome measurement: Week 52
Average difference compared to placebo
3. Other secondary evaluation indicators:
- Outcome variable: Time to first asthma worsening
Outcome measurement: risk of worsening asthma compared to placebo in 52 weeks
-Outcome variable: Proportion of subjects with worsening asthma≥1
Outcome measurement: the difference in proportion compared to placebo at week 52
- Outcome variable: Annual rate of deterioration related to emergency department, emergency care, or hospitalization
Outcome measurement: percentage of annual deterioration rate compared to placebo within 52 weeks
-Outcome variables: changes in the following items since the reference point
- Expiratory Nitric Oxide Concentration (FENO; ppb)
-Periphe-Total serum IgE concentration
Outcome measurement: mean difference compared to placebo at week 52
-Outcome variables: Changes in the following items since the reference point
-Weekly average of emergency medicine usage
-Weekly average of morning and evening peak expiratory flow rate (PEF)
-Weekly average number of night wakefulness
Outcome measurement: mean difference compared to placebo at week 52
-Result variable:
-Use of specific resources for asthma (for example: unscheduled doctor visits, unscheduled doctor phone calls, use of other asthma medications)
-Work Productivity and Activity Impairment (WPAI + CIQ) questionnaire and academic impairment questionnaire scores
-Result measurement:
-Difference in utilization of specific resources for asthma compared with placebo in 52 weeks
-Difference in WPAI + CIQ scores compared to placebo at week 52
-PK: Serum trough concentration
Immunogenicity: incidence of anti-drug antibodies
-Outcome variable: European Quality of Life-5-Oriented 5-Level Daily Life Questionnaire (EQ-5D-5L) score
Outcome measurement: mean difference compared to placebo at week 52
-Outcome variable: the patient's overall impression of the change/severity (PGI-C, PGI-S) and the clinician's overall impression of the change
(CGI-C)
Outcome measurement: response ratio at week 52
4. Safety assessment indicators:
-Adverse Event/Serious Adverse Event
-vital signs
-Clinical chemistry/hematology/urinalysis parameters
-Digital ECG
5. Exploratory evaluation indicators:
-Serum biomarkers, which may include but are not limited to TSLP, IL-33 and TARC
-Specific allergens IgE, total IgE, IgA, IgG and IgM
-Biomarker Transcriptome: RNA Seq and RNA Microarray Analysis
-Selective pharmacogenomic biomarkers: SNP, epigenetic and microbial analysis
-List Th1, Th2, and Th17 cells in whole blood by flow cytometry
-Home FENO for a subgroup of subjects
-FEV1 after BD and forced expiratory flow rate of 20-75% of vital capacity (FEF25-75%)
-FENO, pre-BD FEV1, ACQ-6, asthma symptoms, and changes in emergency medication usage since the baseline
-Changes in sinus-specific HRQoL in patients with nasal polyps at week 58
-Changes in the scores of the St. George's Respiratory Scale (SGRQ) since the reference point
-The incidence of CompEx compared to placebo in 52 weeks. For related definitions, please refer to section 8.1.5 of the plan.
Inclution Criteria
Inclusion conditions
You can only be included in the trial if you meet all of the following inclusion conditions and none of the exclusion conditions are met:
1. If you are an adult (above 20 years old), you must provide a signed certificate before conducting any necessary test specific procedures, sampling and analysis
Written subject consent form with name and date.
2. Before collecting selective samples for genetic analysis, provide a written consent form for genetic subjects with signed name and date. (Taiwan does not Participate in this selective trial)
3. You must be between 20 and 80 years old (inclusive) when you sign the subject's consent form.
4. At least 12 months before the first visit, there is a record of a doctor's diagnosis of asthma.
5. At least 12 months before your first visit, you have received a middle-dose or high-dose inhaled corticosteroid (ICS) prescribed by your doctor for asthma control Preparation of drugs.
6. At least 3 months before the first visit, there is a record of treatment with a total daily dose of medium or high dose of ICS.
7. Must have a record of using additional asthma control drugs at least 3 months before the first visit.
8. Forced expiratory volume (FEV1) in the first second before using bronchodilator (BD) in the morning at the second or second visit (FEV1)
9. Evidence of one of the asthma records:
12 months before the first visit, there was a record of reversible medical history of FEV1≥12% and ≥200 mL.
or
In the screening process of the 2nd or 2a visit, after using BD, it has the reversibility of FEV1≥12% and ≥200 mL.
10. In the 12 months before the first visit, there are at least 2 medical history records of asthma attacks.
11. ACQ-6 score ≥1.5 during screening.
12. The weight at the first visit was ≥40 kg.
13. Female subjects with fertility had a negative serum pregnancy test at the first visit.
14. If you are a fertile woman who is still having sex with a male partner who has not been sterilized, you must use the highly effective
Contraceptive methods, and must agree to continue to use such preventive measures until 16 weeks after the last dose of the test drug.
15. The male contraceptive conditions have been deleted.
16. Randomly assign ACQ-6 scores of the day ≥1.5.
17. Within 7 days before random assignment, meet at least one of the following conditions:
-≥ 2-day day or night symptom score≥1
-> Use short-acting B2 sympathetic nerve stimulant (SABA) relief medication for 2 days
-≥Woke up with breathlessness once
18. Satisfy the minimum filling limit of the daily electronic log during the import period
Full compliance for 18 days).
It is necessary to complete the night electronic log and the subsequent morning electronic log to complete the one-day filling and compliance.
-The introduction period of this condition is defined as the period from the distribution of the electronic log (night evaluation) to the random assignment of visits (morning evaluation)
19. Complete at least 4 days of daily electronic diary within 7 days before random assignment.
20. During the lead-in period, the minimum background asthma medication medication must be observed and recorded in an electronic log (until the date of random allocation).
Day—At least 18 days of the 21 days from day 0 are fully complied with medication).
- If the electronic log data on that day is missing, it will be deemed to have failed to comply with these conditions
21. The inhaler, peak expiratory flow meter, and spirometer can be used during induction.
You can only be included in the trial if you meet all of the following inclusion conditions and none of the exclusion conditions are met:
1. If you are an adult (above 20 years old), you must provide a signed certificate before conducting any necessary test specific procedures, sampling and analysis
Written subject consent form with name and date.
2. Before collecting selective samples for genetic analysis, provide a written consent form for genetic subjects with signed name and date. (Taiwan does not Participate in this selective trial)
3. You must be between 20 and 80 years old (inclusive) when you sign the subject's consent form.
4. At least 12 months before the first visit, there is a record of a doctor's diagnosis of asthma.
5. At least 12 months before your first visit, you have received a middle-dose or high-dose inhaled corticosteroid (ICS) prescribed by your doctor for asthma control Preparation of drugs.
6. At least 3 months before the first visit, there is a record of treatment with a total daily dose of medium or high dose of ICS.
7. Must have a record of using additional asthma control drugs at least 3 months before the first visit.
8. Forced expiratory volume (FEV1) in the first second before using bronchodilator (BD) in the morning at the second or second visit (FEV1)
9. Evidence of one of the asthma records:
12 months before the first visit, there was a record of reversible medical history of FEV1≥12% and ≥200 mL.
or
In the screening process of the 2nd or 2a visit, after using BD, it has the reversibility of FEV1≥12% and ≥200 mL.
10. In the 12 months before the first visit, there are at least 2 medical history records of asthma attacks.
11. ACQ-6 score ≥1.5 during screening.
12. The weight at the first visit was ≥40 kg.
13. Female subjects with fertility had a negative serum pregnancy test at the first visit.
14. If you are a fertile woman who is still having sex with a male partner who has not been sterilized, you must use the highly effective
Contraceptive methods, and must agree to continue to use such preventive measures until 16 weeks after the last dose of the test drug.
15. The male contraceptive conditions have been deleted.
16. Randomly assign ACQ-6 scores of the day ≥1.5.
17. Within 7 days before random assignment, meet at least one of the following conditions:
-≥ 2-day day or night symptom score≥1
-> Use short-acting B2 sympathetic nerve stimulant (SABA) relief medication for 2 days
-≥Woke up with breathlessness once
18. Satisfy the minimum filling limit of the daily electronic log during the import period
Full compliance for 18 days).
It is necessary to complete the night electronic log and the subsequent morning electronic log to complete the one-day filling and compliance.
-The introduction period of this condition is defined as the period from the distribution of the electronic log (night evaluation) to the random assignment of visits (morning evaluation)
19. Complete at least 4 days of daily electronic diary within 7 days before random assignment.
20. During the lead-in period, the minimum background asthma medication medication must be observed and recorded in an electronic log (until the date of random allocation).
Day—At least 18 days of the 21 days from day 0 are fully complied with medication).
- If the electronic log data on that day is missing, it will be deemed to have failed to comply with these conditions
21. The inhaler, peak expiratory flow meter, and spirometer can be used during induction.
Exclusion Criteria
Exclude conditions
1. In addition to asthma, any clinically important lung disease (for example: active lung infection, chronic obstructive pulmonary disease (COPD), Bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity-related hypoventilation syndrome, lung cancer, alpha antitrypsin
Deficiency and congenital ciliary dyskinesia), or pulmonary or systemic related to an increase in the number of peripheral eosinophils other than asthma Diseases (e.g. allergic bronchopulmonary aspergillosis/mycosis, Chagg-Strauss syndrome, eosinophilia syndrome).
2. Suffer from any disease considered unstable by the experimental physician, including but not limited to cardiovascular, gastrointestinal tract, liver, kidney, nerve, musculoskeletal Skeletal, infectious, endocrine, metabolic, hematological, mental or major physical damage, and may:
Affect your safety throughout the trial period
Affect the discovery of the trial or its interpretation
prevents you from completing the entire trial period
3. With a history of cancer.
-Subjects suffering from basal cell carcinoma, cutaneous squamous cell carcinoma in situ or cervical carcinoma in situ are eligible for trial participation as long as they complete the curative course of treatment at least 12 months before the first visit.
�{-Subjects who have suffered from other malignant tumors are eligible as long as they have completed a curative course of treatment at least 5 years before the first visit.
4. Have a history of major clinical infections including upper (URTI) or lower respiratory tract infection (LRTI), which must be introduced within 2 weeks before the first visit
Complete antibiotic or antiviral treatment during this period.
5. Parasitic helminth infection is diagnosed within 6 months before the first visit and has not been treated or has not been treated with standard care.
6. Subjects who currently have smoking or smoking history ≥10 pack-years and have used e-cigarettes. Smokers and e-cigarette users with a past smoking history of <10 pack-years must stop smoking at least 6 months before the first visit to be eligible.
7. A history of alcohol or drug abuse within 12 months before the first visit.
8. Suffer from tuberculosis that requires treatment within 12 months before the first visit.
9. Judging by the medical history and/or your oral report, you have a known history of immunodeficiency diseases, including human immunity at the first visit
Lack of virus (HIV) test positive, or you are taking antiretroviral drugs.
10. Major operations have been performed within 8 weeks before the first visit, or operations that require general anesthesia or hospitalization for> 1 day are planned during the trial period.
11. Accept any marketed or experimental biological agents within 4 months or 5 half-lives (whichever is longer) before the first visit, or in the first
Accept any experimental non-biological agents 30 days before the second visit or within 5 half-lives (whichever is longer).
12. In the last 12 weeks before randomization, the following drugs were used for treatment: systemic immunity except for maintaining stable oral corticosteroids (OCS)
Epidemic suppression/immunomodulation drugs (for example: methotrexate, cyclosporine, etc.).
13. Received immunoglobulin or blood preparations within 30 days before the first visit.
14. Received T2 cytokine inhibitor Suplatast tosilate within 15 days before the first visit.
15. Receive live attenuated vaccines within 30 days before the random assignment date and during the trial period (including the follow-up period).
16. You had undergone bronchial cauterization surgery in the last 12 months before the first visit.
17. A history of allergies to the ingredients of any test drug formulation is known, or the test physician or medical monitor is prohibited from participating in the test.
History of tested drugs or other allergies.
18. There have been records of allergic reactions or immune complex diseases after receiving any biological treatments (Category III allergic reactions).
19. At the same time participate in another clinical trial involving an experimental drug.
20. You have received random assignment in the current trial or previous Tezepelumab trial.
21. You have been involved in test planning and/or execution (applicable to AstraZeneca employees and/or test center employees), or you are a test center or
The test client is hired by or has relatives with its employees.
22. You have any role in physical examination, vital signs, electrocardiogram (ECG), hematology, clinical chemistry or urinalysis during the import period.
Any abnormal findings of clinical significance, as determined by the trial physician, may expose you to risks due to participation in this trial, or may affect the trial
Test results or your ability to complete the test.
23. There is evidence of active liver disease, including jaundice or aspartate transamidation酶, alanine transamidation
enzyme or alkaline phosphoric acid enzyme exceeding the upper limit of normal (ULN) 2 times the above.
24. At the time of screening, hepatitis B surface antigen or hepatitis C antibody was serologically positive, or he had a history of hepatitis B or C positive. Allowable
Participants who have a record of hepatitis B vaccination but no history of hepatitis B will participate.
25. Women who are pregnant, breastfeeding or lactating.
Women with childbearing potential must take blood for serum β-HCG pregnancy test (including young girls) at the screening visit. If the result of serum β-HCG cannot be obtained before the administration of the test drug, the subject's urine pregnancy test must be negative to be included, but the result of serum β-HCG must still be obtained. If one of the tests is positive, the subject should be excluded. Since urine and serum testing may miss the initial pregnancy status after conception, the relevant menstrual cycle and sexual life status (including contraceptive methods) should still be considered. Any subject whose menstrual and/or sexual life status has the possibility of early pregnancy should be excluded.
26. In the judgment of the trial physician, you are unwilling or unable to follow the trial procedures.
27. If you are almost unable to comply with the trial procedures, restrictions and requirements, the trial physician has ruled that you should not participate in the trial.
1. In addition to asthma, any clinically important lung disease (for example: active lung infection, chronic obstructive pulmonary disease (COPD), Bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity-related hypoventilation syndrome, lung cancer, alpha antitrypsin
Deficiency and congenital ciliary dyskinesia), or pulmonary or systemic related to an increase in the number of peripheral eosinophils other than asthma Diseases (e.g. allergic bronchopulmonary aspergillosis/mycosis, Chagg-Strauss syndrome, eosinophilia syndrome).
2. Suffer from any disease considered unstable by the experimental physician, including but not limited to cardiovascular, gastrointestinal tract, liver, kidney, nerve, musculoskeletal Skeletal, infectious, endocrine, metabolic, hematological, mental or major physical damage, and may:
Affect your safety throughout the trial period
Affect the discovery of the trial or its interpretation
prevents you from completing the entire trial period
3. With a history of cancer.
-Subjects suffering from basal cell carcinoma, cutaneous squamous cell carcinoma in situ or cervical carcinoma in situ are eligible for trial participation as long as they complete the curative course of treatment at least 12 months before the first visit.
�{-Subjects who have suffered from other malignant tumors are eligible as long as they have completed a curative course of treatment at least 5 years before the first visit.
4. Have a history of major clinical infections including upper (URTI) or lower respiratory tract infection (LRTI), which must be introduced within 2 weeks before the first visit
Complete antibiotic or antiviral treatment during this period.
5. Parasitic helminth infection is diagnosed within 6 months before the first visit and has not been treated or has not been treated with standard care.
6. Subjects who currently have smoking or smoking history ≥10 pack-years and have used e-cigarettes. Smokers and e-cigarette users with a past smoking history of <10 pack-years must stop smoking at least 6 months before the first visit to be eligible.
7. A history of alcohol or drug abuse within 12 months before the first visit.
8. Suffer from tuberculosis that requires treatment within 12 months before the first visit.
9. Judging by the medical history and/or your oral report, you have a known history of immunodeficiency diseases, including human immunity at the first visit
Lack of virus (HIV) test positive, or you are taking antiretroviral drugs.
10. Major operations have been performed within 8 weeks before the first visit, or operations that require general anesthesia or hospitalization for> 1 day are planned during the trial period.
11. Accept any marketed or experimental biological agents within 4 months or 5 half-lives (whichever is longer) before the first visit, or in the first
Accept any experimental non-biological agents 30 days before the second visit or within 5 half-lives (whichever is longer).
12. In the last 12 weeks before randomization, the following drugs were used for treatment: systemic immunity except for maintaining stable oral corticosteroids (OCS)
Epidemic suppression/immunomodulation drugs (for example: methotrexate, cyclosporine, etc.).
13. Received immunoglobulin or blood preparations within 30 days before the first visit.
14. Received T2 cytokine inhibitor Suplatast tosilate within 15 days before the first visit.
15. Receive live attenuated vaccines within 30 days before the random assignment date and during the trial period (including the follow-up period).
16. You had undergone bronchial cauterization surgery in the last 12 months before the first visit.
17. A history of allergies to the ingredients of any test drug formulation is known, or the test physician or medical monitor is prohibited from participating in the test.
History of tested drugs or other allergies.
18. There have been records of allergic reactions or immune complex diseases after receiving any biological treatments (Category III allergic reactions).
19. At the same time participate in another clinical trial involving an experimental drug.
20. You have received random assignment in the current trial or previous Tezepelumab trial.
21. You have been involved in test planning and/or execution (applicable to AstraZeneca employees and/or test center employees), or you are a test center or
The test client is hired by or has relatives with its employees.
22. You have any role in physical examination, vital signs, electrocardiogram (ECG), hematology, clinical chemistry or urinalysis during the import period.
Any abnormal findings of clinical significance, as determined by the trial physician, may expose you to risks due to participation in this trial, or may affect the trial
Test results or your ability to complete the test.
23. There is evidence of active liver disease, including jaundice or aspartate transamidation酶, alanine transamidation
enzyme or alkaline phosphoric acid enzyme exceeding the upper limit of normal (ULN) 2 times the above.
24. At the time of screening, hepatitis B surface antigen or hepatitis C antibody was serologically positive, or he had a history of hepatitis B or C positive. Allowable
Participants who have a record of hepatitis B vaccination but no history of hepatitis B will participate.
25. Women who are pregnant, breastfeeding or lactating.
Women with childbearing potential must take blood for serum β-HCG pregnancy test (including young girls) at the screening visit. If the result of serum β-HCG cannot be obtained before the administration of the test drug, the subject's urine pregnancy test must be negative to be included, but the result of serum β-HCG must still be obtained. If one of the tests is positive, the subject should be excluded. Since urine and serum testing may miss the initial pregnancy status after conception, the relevant menstrual cycle and sexual life status (including contraceptive methods) should still be considered. Any subject whose menstrual and/or sexual life status has the possibility of early pregnancy should be excluded.
26. In the judgment of the trial physician, you are unwilling or unable to follow the trial procedures.
27. If you are almost unable to comply with the trial procedures, restrictions and requirements, the trial physician has ruled that you should not participate in the trial.
The Estimated Number of Participants
-
Taiwan
27 participants
-
Global
2120 participants
