Clinical Trials List
Protocol NumberD2210C00007
2015-07-01 - 2015-12-12
Others
Terminated3
Study ended1
ICD-10J45.52
Severe persistent asthma with status asthmaticus
ICD-9493.01
Extrinsic asthma with status asthmaticus
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist (STRATOS 1)
-
Trial Applicant
-
Sponsor
AstraZeneca
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳正雄 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 王秉槐 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 邱建通 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 梁信杰 Division of Thoracic Medicine
- 廖偉志 Division of Thoracic Medicine
- Chih-Yen Tu Division of Thoracic Medicine
- Shuo-Chueh Chen Division of Thoracic Medicine
- Chia-Hsiang Li Division of Thoracic Medicine
- Chih-Ching Yen Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
- 程味兒 Division of Thoracic Medicine
- Yu-Chao Lin Division of Thoracic Medicine
Condition/Disease
Asthma Inadequately Controlled
Objectives
Primary Objective:To evaluate the effect of tralokinumab 300mg administered every 2 weeks comparedwith placebo on the annualised asthmaexacerbation rate in adult and adolescentsubjects with asthma that is inadequatelycontrolled with inhaled corticosteroid pluslong-acting β2-agonist
Test Drug
Tralokinumab
Active Ingredient
Humanized anti-IL-13 mAb
Dosage Form
injection
Dosage
150
Endpoints
Primary outcome variable: The annualised
asthma exacerbation rate up to Week 52
Primary outcome measure: Asthma
exacerbation rate reduction
asthma exacerbation rate up to Week 52
Primary outcome measure: Asthma
exacerbation rate reduction
Inclution Criteria
1. Provision of informed consent prior to any study specific procedures for subjects
who are at, or over the age of majority (as per local law). For subjects less than the
age of majority, in addition to the subject providing informed assent, the subject’s
legal guardian must also provide their informed consent.
2. Female and male aged from 12 to 75 years, inclusively. A subject will need to be 12
years of age at the time of enrolment. Subjects at the upper end of the age spectrum
will need to be 75 years of age at the time of randomization. (For those countries
where local regulations permit enrolment of adults only, subject recruitment will be
restricted to those who are ≥18 years).
3. Women of childbearing potential (WOCBP) must use a highly effective form of
birth control (confirmed by the investigator). Highly effective forms of birth control
includes: true sexual abstinence, a vasectomised sexual partner, Implanon, female
sterilization by tubal occlusion, any effective intrauterine device/system (IUD/IUS),
Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™.
WOCBP must agree to use highly effective method of birth control, as defined
above, from enrolment, throughout the study duration and within 16 after last dose
of investigational product (IP), and have negative serum pregnancy test result at
Visit 1.
Women not of childbearing potential are defined as women who are either
permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral
salpingectomy), or who are postmenopausal. Women will be considered
postemenopausal if they have been amenorrheic for 12 months prior to the planned
date of randomization without an alternative medical cause. The following agespecific requirements apply:
• Women <50 years old would be considered postmenopausal if they have
been amenorrheic for 12 months or more following cessation of exogenous
hormonal treatment and follicle stimulating hormone (FSH) levels in the
postmenopausal range.
• Women ≥50 years old would be considered postmenopausal if they have
been amenorrheic for 12 months or more following cessation of all
exogenous hormonal treatment.
4. Weight of ≥30 and <150 kg at enrolment (Visit 1). For adults (≥ 18 years of age)
the weight must not be below 40 kg.
5. Documented physician-diagnosed asthma for at least 12 months prior to enrolment
with the subject having received an asthma controller regimen requiring treatment
with medium-to-high dose ICS for at least 6 of the 12 months prior to enrolment
(Visit 1). In addition, subjects must have used physician prescribed ICS (at a total
daily dose ≥500μg fluticasone propionate via dry powder inhaler or equivalent
delivered dose) that has been taken at a stable dose for at least 3 months prior to
enrolment.
6. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
fluticasone propionate dry powder formulation equivalents) and a LABA for at least
3 months prior to Visit 1. The ICS and LABA can be parts of a combination
product, or given by separate inhalers.
• In order to aid the assessment, ICS equivalents for high-dose and moderatedose fluticasone propionate dry powder, as published by the Global
Initiative for Asthma (GINA 2012) guidelines, are presented in Appendix
F. The Investigator will assess the subject’s total daily ICS dose and
determine that it corresponds to ≥500μg fluticasone propionate dry powder
formulation equivalents. If the subject is on two or more different types of
ICS, these can form parts of an addition, and the sum, however
approximate, will be assessed.
7. Additional maintenance asthma controller medications (eg, LTRAs, cromone,
theophylline), that have been stable for at least 30 days prior to Visit 1, are allowed.
Long-acting anticholinergics (eg, tiotropium) are not allowed 30 days prior to Visit1
and throughout the study duration. Use of any off-label medications, for example
medications locally approved for chronic obstructive pulmonary disease (COPD)
but not for asthma, are also not allowed from 30 days prior to Visit 1 and throughout
the duration of the study. Furthermore, after randomization, the subject's
background maintenance medication for asthma shall remain unchanged throughout
the study.
8. At Visit 1 the subject must have a morning pre-BD FEV1 value <80% (<90% for
patients 12 to 17 years of age) of their predicted normal value (PNV). At Visit 2 the
subject must have a morning pre-BD FEV1 value of ≥40 and <80% value (<90% for
patients 12 to 17 years of age) of their PNV. If this is not met at Visit 2, it must be
met at Visit 3.
9. A post-BD reversibility of ≥12% and ≥200 mL in FEV1 at Visit 2. If not met at Visit
2, it must be met at Visit 3 (randomization). Before reversibility testing, the subject
should refrain from taking their short-acting inhaled β2-agonist (SABA)/LABA for
the amount of time that depends on the BD being taken.
10. At least 2 documented asthma exacerbations in the 12 months prior to the date
informed consent is obtained that required use of a systemic corticosteroid. In case
of subjects who are re-screened within 30 days of their screen failure date; the 12
months can be calculated from the date that the first informed consent was obtained.
11. ACQ-6 score ≥1.5 at Visit 1 (Week - 6)
who are at, or over the age of majority (as per local law). For subjects less than the
age of majority, in addition to the subject providing informed assent, the subject’s
legal guardian must also provide their informed consent.
2. Female and male aged from 12 to 75 years, inclusively. A subject will need to be 12
years of age at the time of enrolment. Subjects at the upper end of the age spectrum
will need to be 75 years of age at the time of randomization. (For those countries
where local regulations permit enrolment of adults only, subject recruitment will be
restricted to those who are ≥18 years).
3. Women of childbearing potential (WOCBP) must use a highly effective form of
birth control (confirmed by the investigator). Highly effective forms of birth control
includes: true sexual abstinence, a vasectomised sexual partner, Implanon, female
sterilization by tubal occlusion, any effective intrauterine device/system (IUD/IUS),
Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™.
WOCBP must agree to use highly effective method of birth control, as defined
above, from enrolment, throughout the study duration and within 16 after last dose
of investigational product (IP), and have negative serum pregnancy test result at
Visit 1.
Women not of childbearing potential are defined as women who are either
permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral
salpingectomy), or who are postmenopausal. Women will be considered
postemenopausal if they have been amenorrheic for 12 months prior to the planned
date of randomization without an alternative medical cause. The following agespecific requirements apply:
• Women <50 years old would be considered postmenopausal if they have
been amenorrheic for 12 months or more following cessation of exogenous
hormonal treatment and follicle stimulating hormone (FSH) levels in the
postmenopausal range.
• Women ≥50 years old would be considered postmenopausal if they have
been amenorrheic for 12 months or more following cessation of all
exogenous hormonal treatment.
4. Weight of ≥30 and <150 kg at enrolment (Visit 1). For adults (≥ 18 years of age)
the weight must not be below 40 kg.
5. Documented physician-diagnosed asthma for at least 12 months prior to enrolment
with the subject having received an asthma controller regimen requiring treatment
with medium-to-high dose ICS for at least 6 of the 12 months prior to enrolment
(Visit 1). In addition, subjects must have used physician prescribed ICS (at a total
daily dose ≥500μg fluticasone propionate via dry powder inhaler or equivalent
delivered dose) that has been taken at a stable dose for at least 3 months prior to
enrolment.
6. Documented treatment with ICS at a total daily dose corresponding to ≥500μg
fluticasone propionate dry powder formulation equivalents) and a LABA for at least
3 months prior to Visit 1. The ICS and LABA can be parts of a combination
product, or given by separate inhalers.
• In order to aid the assessment, ICS equivalents for high-dose and moderatedose fluticasone propionate dry powder, as published by the Global
Initiative for Asthma (GINA 2012) guidelines, are presented in Appendix
F. The Investigator will assess the subject’s total daily ICS dose and
determine that it corresponds to ≥500μg fluticasone propionate dry powder
formulation equivalents. If the subject is on two or more different types of
ICS, these can form parts of an addition, and the sum, however
approximate, will be assessed.
7. Additional maintenance asthma controller medications (eg, LTRAs, cromone,
theophylline), that have been stable for at least 30 days prior to Visit 1, are allowed.
Long-acting anticholinergics (eg, tiotropium) are not allowed 30 days prior to Visit1
and throughout the study duration. Use of any off-label medications, for example
medications locally approved for chronic obstructive pulmonary disease (COPD)
but not for asthma, are also not allowed from 30 days prior to Visit 1 and throughout
the duration of the study. Furthermore, after randomization, the subject's
background maintenance medication for asthma shall remain unchanged throughout
the study.
8. At Visit 1 the subject must have a morning pre-BD FEV1 value <80% (<90% for
patients 12 to 17 years of age) of their predicted normal value (PNV). At Visit 2 the
subject must have a morning pre-BD FEV1 value of ≥40 and <80% value (<90% for
patients 12 to 17 years of age) of their PNV. If this is not met at Visit 2, it must be
met at Visit 3.
9. A post-BD reversibility of ≥12% and ≥200 mL in FEV1 at Visit 2. If not met at Visit
2, it must be met at Visit 3 (randomization). Before reversibility testing, the subject
should refrain from taking their short-acting inhaled β2-agonist (SABA)/LABA for
the amount of time that depends on the BD being taken.
10. At least 2 documented asthma exacerbations in the 12 months prior to the date
informed consent is obtained that required use of a systemic corticosteroid. In case
of subjects who are re-screened within 30 days of their screen failure date; the 12
months can be calculated from the date that the first informed consent was obtained.
11. ACQ-6 score ≥1.5 at Visit 1 (Week - 6)
Exclusion Criteria
1. Clinically important pulmonary disease other than asthma (eg, active lung infection,
COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation
syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and
primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic
disease, other than asthma, that are associated with elevated peripheral eosinophil
counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss
syndrome, hypereosinophilic syndrome).
2. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic,
renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
haematological, psychiatric, or major physical impairment that is not stable in the
opinion of the Investigator and could:
• Affect the safety of the subject throughout the study
• Influence the findings of the studies or their interpretations
• Impede the subject’s ability to complete the entire duration of study
3. Known history of allergy or reaction to any component of the IP formulation.
4. History of anaphylaxis following any biologic therapy
5. A helminth parasitic infection diagnosed within 6 months prior to the date informed
consent or assent obtained that has not been treated with, or has failed to respond to,
standard of care therapy.
6. History of clinically significant infection, including acute upper or lower respiratory
infections, requiring antibiotics or antiviral medication within 30 days prior to the
date informed consent or assent is obtained or during the run-in period.
7. Tuberculosis requiring treatment within the 12 months prior to enrolment (Visit 1).
8. Any clinically significant abnormal findings in physical examination, vital signs,
dECG, haematology, clinical chemistry, or urinalysis during the run-in period,
which in the opinion of the Investigator, may put the subject at risk because of
his/her participation in the study, or may influence the results of the study, or the
subject’s ability to complete entire duration of the study.
9. History of chronic alcohol or drug abuse within 12 months of the enrolment visit, or
a condition associated with poor compliance as judged by the Investigator.
10. Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Subjects
with a history of hepatitis B vaccination without a history of hepatitis B are allowed
to be enrolled.
11. History of any known primary immunodeficiency disorder including a positive
human immunodeficiency virus (HIV) test at enrolment, or the subject taking
antiretroviral medications as determined by medical history and/or subject’s verbal
report.
12. Current tobacco smoking (smoking must have stopped for ≥ 3 months prior to
enrolment) or a history of tobacco smoking for ≥ 10 pack-years (one pack year = 20
cigarettes smoked per day for 1 year).
13. History of cancer:
• Subjects who have had basal cell carcinoma, localized squamous cell
carcinoma of the skin or in situ carcinoma of the cervix are eligible provided
that the subject is in remission and curative therapy was completed at least 12
months prior to the date informed consent was obtained.
• Subjects who have had other malignancies are eligible provided that the subject
is in remission and curative therapy was completed at least 5 years prior to the
date informed consent was obtained.
14. Use of immunosuppressive medication (including but not limited to: methotrexate,
troleandomycin, cyclosporine, azathioprine, systemic corticosteroids including
regular treatment with OCS and intramuscular long-acting depot corticosteroids, or
any experimental anti-inflammatory therapy) within 3 months prior to the date
informed consent or assent is obtained.
15. Clinically significant asthma exacerbation, in the opinion of the Investigator,
including those requiring use of OCS 30 days prior to the date of informed consent
or during the screening/run-in period.
16. Receipt of immunoglobulin or blood products within 30 days prior to the date
informed consent or assent is obtained.
17. Receipt of any marketed or investigational biologic agent (eg. omalizumab) within 4
months or 5 half-lives prior to the enrolment visit, whichever is longer.
18. Receipt of live attenuated vaccines 30 days prior to the date of randomization and
during the study including the follow-up period.
• Receipt of inactive/killed vaccinations (eg, inactive influenza) are allowed,
provided they are not administered within 5 days before/after any study visit.
19. Receipt of any investigational non-biologic agent within 30 days or 5 half lives prior
to informed consent or assent being obtained, whichever is longer.
20. Previous receipt of tralokinumab (CAT-354).
21. Initiation of new allergen immunotherapy or change in existing immunotherapy is
not allowed within 30 days prior to the date of informed consent. However, allergen
immunotherapy initiated prior to this period may be continued provided there is a
span of at least 5 days between the immunotherapy and IP administration.
22. Current use of any oral or ophthalmic β-adrenergic antagonist (eg, propranolol).
23. Major surgery within 8 weeks prior to the enrolment visit, or planned in-subject
surgery or hospitalization during the study period.
24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5
times the upper limit of normal (ULN) at enrolment.
25. Pregnant, currently breast-feeding, or lactating women.
26. Previous randomization in the present study.
27. Concurrent enrolment in another clinical study where the subject is receiving an IP.
28. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site).
29. Employees of the clinical study site or any other individuals directly involved with
the planning or conduct of the study, or immediate family members of such
individuals.
30. Individuals who are legally institutionalized.
COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation
syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and
primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic
disease, other than asthma, that are associated with elevated peripheral eosinophil
counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss
syndrome, hypereosinophilic syndrome).
2. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic,
renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
haematological, psychiatric, or major physical impairment that is not stable in the
opinion of the Investigator and could:
• Affect the safety of the subject throughout the study
• Influence the findings of the studies or their interpretations
• Impede the subject’s ability to complete the entire duration of study
3. Known history of allergy or reaction to any component of the IP formulation.
4. History of anaphylaxis following any biologic therapy
5. A helminth parasitic infection diagnosed within 6 months prior to the date informed
consent or assent obtained that has not been treated with, or has failed to respond to,
standard of care therapy.
6. History of clinically significant infection, including acute upper or lower respiratory
infections, requiring antibiotics or antiviral medication within 30 days prior to the
date informed consent or assent is obtained or during the run-in period.
7. Tuberculosis requiring treatment within the 12 months prior to enrolment (Visit 1).
8. Any clinically significant abnormal findings in physical examination, vital signs,
dECG, haematology, clinical chemistry, or urinalysis during the run-in period,
which in the opinion of the Investigator, may put the subject at risk because of
his/her participation in the study, or may influence the results of the study, or the
subject’s ability to complete entire duration of the study.
9. History of chronic alcohol or drug abuse within 12 months of the enrolment visit, or
a condition associated with poor compliance as judged by the Investigator.
10. Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Subjects
with a history of hepatitis B vaccination without a history of hepatitis B are allowed
to be enrolled.
11. History of any known primary immunodeficiency disorder including a positive
human immunodeficiency virus (HIV) test at enrolment, or the subject taking
antiretroviral medications as determined by medical history and/or subject’s verbal
report.
12. Current tobacco smoking (smoking must have stopped for ≥ 3 months prior to
enrolment) or a history of tobacco smoking for ≥ 10 pack-years (one pack year = 20
cigarettes smoked per day for 1 year).
13. History of cancer:
• Subjects who have had basal cell carcinoma, localized squamous cell
carcinoma of the skin or in situ carcinoma of the cervix are eligible provided
that the subject is in remission and curative therapy was completed at least 12
months prior to the date informed consent was obtained.
• Subjects who have had other malignancies are eligible provided that the subject
is in remission and curative therapy was completed at least 5 years prior to the
date informed consent was obtained.
14. Use of immunosuppressive medication (including but not limited to: methotrexate,
troleandomycin, cyclosporine, azathioprine, systemic corticosteroids including
regular treatment with OCS and intramuscular long-acting depot corticosteroids, or
any experimental anti-inflammatory therapy) within 3 months prior to the date
informed consent or assent is obtained.
15. Clinically significant asthma exacerbation, in the opinion of the Investigator,
including those requiring use of OCS 30 days prior to the date of informed consent
or during the screening/run-in period.
16. Receipt of immunoglobulin or blood products within 30 days prior to the date
informed consent or assent is obtained.
17. Receipt of any marketed or investigational biologic agent (eg. omalizumab) within 4
months or 5 half-lives prior to the enrolment visit, whichever is longer.
18. Receipt of live attenuated vaccines 30 days prior to the date of randomization and
during the study including the follow-up period.
• Receipt of inactive/killed vaccinations (eg, inactive influenza) are allowed,
provided they are not administered within 5 days before/after any study visit.
19. Receipt of any investigational non-biologic agent within 30 days or 5 half lives prior
to informed consent or assent being obtained, whichever is longer.
20. Previous receipt of tralokinumab (CAT-354).
21. Initiation of new allergen immunotherapy or change in existing immunotherapy is
not allowed within 30 days prior to the date of informed consent. However, allergen
immunotherapy initiated prior to this period may be continued provided there is a
span of at least 5 days between the immunotherapy and IP administration.
22. Current use of any oral or ophthalmic β-adrenergic antagonist (eg, propranolol).
23. Major surgery within 8 weeks prior to the enrolment visit, or planned in-subject
surgery or hospitalization during the study period.
24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5
times the upper limit of normal (ULN) at enrolment.
25. Pregnant, currently breast-feeding, or lactating women.
26. Previous randomization in the present study.
27. Concurrent enrolment in another clinical study where the subject is receiving an IP.
28. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site).
29. Employees of the clinical study site or any other individuals directly involved with
the planning or conduct of the study, or immediate family members of such
individuals.
30. Individuals who are legally institutionalized.
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
1140 participants
