Clinical Trials List
Protocol Number1311.14
NCT Number(ClinicalTrials.gov Identfier)NCT02443298
2015-09-01 - 2018-04-30
Phase II
Terminated6
ICD-10J45
Asthma
A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066 as add-on therapy over 24 weeks in patients with severe persistent asthma.
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 游騰仁 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 廖偉志 Division of Thoracic Medicine
- 程味兒 Division of Thoracic Medicine
- Chia-Hsiang Li Division of Thoracic Medicine
- 梁信杰 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 潘聖衛 Division of Thoracic Medicine
- D.W. Peng Division of Thoracic Medicine
- 余文光 Division of Thoracic Medicine
- Hsin-Kuo Ko Division of Thoracic Medicine
- 周昆達 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 許嘉林 Division of Thoracic Medicine
- Jung-Yien Chien Division of Thoracic Medicine
- Shih-Chi Ku Division of Thoracic Medicine
- 阮聖元 Division of Thoracic Medicine
- HAO-CHIEN WANG Division of Thoracic Medicine
- 鄭之勛 Division of Thoracic Medicine
- Ping-Hung Kuo Division of Thoracic Medicine
- 錢穎群 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Severe persistent asthma
Objectives
Evaluate efficacy and safety of BI 655066 compared to placebo in patients with
severe persistent asthma over a 24-week treatment period.
Test Drug
BI 655066
Active Ingredient
BI 655066
Dosage Form
Injection
Dosage
90
Endpoints
Primary efficacy endpoint:
Time to first asthma worsening during the planned 24-week treatment period.
Secondary efficacy endpoints:
1. Annualized rate of asthma worsening during the planned 24-week treatment
period
2. Annualized rate of severe asthma exacerbation during the planned 24-week
treatment period
3. Weekly ACQ5 score at week 24
4. Trough FEV1 in-clinic change from baseline at week 24
5. Post-bronchodilator FEV1 in-clinic change from baseline at week 24
6. Time to first severe asthma exacerbation during the planned 24-week treatment period
Time to first asthma worsening during the planned 24-week treatment period.
Secondary efficacy endpoints:
1. Annualized rate of asthma worsening during the planned 24-week treatment
period
2. Annualized rate of severe asthma exacerbation during the planned 24-week
treatment period
3. Weekly ACQ5 score at week 24
4. Trough FEV1 in-clinic change from baseline at week 24
5. Post-bronchodilator FEV1 in-clinic change from baseline at week 24
6. Time to first severe asthma exacerbation during the planned 24-week treatment period
Inclution Criteria
Inclusion criteria
1. Signed informed consent consistent with ICH-GCP guidelines and local legislation prior
to participation in the trial. Medication washout and medication restrictions are allowed
only after signed informed consent is obtained.
2. Male or female patients aged at least 18 years but not more than 75 years at the time of
informed consent.
3. Pre-bronchodilator clinic measured FEV1 of ≥40% and ≤85% of predicted normal at the
screening Visit 1B, and not lower than 40% of predicted normal at randomization visit
(Visit 2). Calculations will be based on Global Lung Function (GLI) formula
(R15-0845).
4. A minimum of one year history of asthma, diagnosed by a physician, and have FEV1
reversibility of at least 12% and an absolute change of at least 200 mL starting within
15 to 30 minutes after administration of 400 µg salbutamol (albuterol) at the screening
Visit 1B (see Appendix 10.1). If reversibility cannot be achieved, documented evidence
of reversibility in the 12 months prior to the screening visit is acceptable.
Note: Reversibility testing can be repeated twice during the screening period if
reversibility cannot be achieved at the screening visit and if documented evidence of
historic reversibility (in the past 12 months) is not available.
5. Patients must be on at least medium dose ICS (Table 10.1: 1), and at least one other
asthma controller medication for at least one year prior to the date of screening. Asthma
therapy must have been documented and must be stable for at least 6 weeks prior to the
date of screening.
Note: Some examples of 2
nd controller medications are long-acting beta-2- agonist
(LABA), leukotriene receptor antagonist (LTRA) or theophylline. Maintenance oral
corticosteroid (prednisone or equivalent) with a total daily dose of ≤ 20 mg is also
considered as an additional controller therapy.
6. Patients must have documented history of two or more severe asthma exacerbations in the
12 months prior to the date of screening, but not within 6 weeks prior to screening.
Note: Severe asthma exacerbation is defined as initiation of systemic corticosteroids:
oral (prednisone or equivalent) or i.v. for 3 or more consecutive days, or a single i.m
dose for asthma. Additionally, for subjects on maintenance systemic corticosteroids,
at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for
three or more consecutive days will be considered a severe asthma exacerbation.
7. Patients should be non-smokers or ex-smokers who stopped smoking at least one year
prior to screening. Ex-smokers must have a smoking history of less than 10-pack years
(see Appendix 10.1).
8. Patients must be able to perform all trial related procedures including pulmonary function
tests, and must be able to use the electronic asthma monitor (E-diary).
1. Signed informed consent consistent with ICH-GCP guidelines and local legislation prior
to participation in the trial. Medication washout and medication restrictions are allowed
only after signed informed consent is obtained.
2. Male or female patients aged at least 18 years but not more than 75 years at the time of
informed consent.
3. Pre-bronchodilator clinic measured FEV1 of ≥40% and ≤85% of predicted normal at the
screening Visit 1B, and not lower than 40% of predicted normal at randomization visit
(Visit 2). Calculations will be based on Global Lung Function (GLI) formula
(R15-0845).
4. A minimum of one year history of asthma, diagnosed by a physician, and have FEV1
reversibility of at least 12% and an absolute change of at least 200 mL starting within
15 to 30 minutes after administration of 400 µg salbutamol (albuterol) at the screening
Visit 1B (see Appendix 10.1). If reversibility cannot be achieved, documented evidence
of reversibility in the 12 months prior to the screening visit is acceptable.
Note: Reversibility testing can be repeated twice during the screening period if
reversibility cannot be achieved at the screening visit and if documented evidence of
historic reversibility (in the past 12 months) is not available.
5. Patients must be on at least medium dose ICS (Table 10.1: 1), and at least one other
asthma controller medication for at least one year prior to the date of screening. Asthma
therapy must have been documented and must be stable for at least 6 weeks prior to the
date of screening.
Note: Some examples of 2
nd controller medications are long-acting beta-2- agonist
(LABA), leukotriene receptor antagonist (LTRA) or theophylline. Maintenance oral
corticosteroid (prednisone or equivalent) with a total daily dose of ≤ 20 mg is also
considered as an additional controller therapy.
6. Patients must have documented history of two or more severe asthma exacerbations in the
12 months prior to the date of screening, but not within 6 weeks prior to screening.
Note: Severe asthma exacerbation is defined as initiation of systemic corticosteroids:
oral (prednisone or equivalent) or i.v. for 3 or more consecutive days, or a single i.m
dose for asthma. Additionally, for subjects on maintenance systemic corticosteroids,
at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for
three or more consecutive days will be considered a severe asthma exacerbation.
7. Patients should be non-smokers or ex-smokers who stopped smoking at least one year
prior to screening. Ex-smokers must have a smoking history of less than 10-pack years
(see Appendix 10.1).
8. Patients must be able to perform all trial related procedures including pulmonary function
tests, and must be able to use the electronic asthma monitor (E-diary).
Exclusion Criteria
Exclusion criteria
1. Patients with a significant disease other than asthma. A significant disease is defined as a
disease which in the opinion of the Investigator may a) put the patient at risk because of
participation in the trial, or b) influence the results of the trial, or c) cause concern on the
patient’s ability to participate in the trial.
2. Patients with malignancy for which the patient has undergone resection, radiation, or
chemotherapy within the past 5 years. Patients with treated basal cell carcinoma or fully
cured squamous cell carcinoma are allowed.
3. Patients with clinically relevant abnormal hematology or blood chemistry laboratory
values at screening if the abnormality defines a significant disease as defined in Exclusion
Criterion 1.
4. Patients who are not able to produce sputum or sputum samples of sufficient quality at the
screening visit. Sputum samples with more than 40% squamous cells or low viability at
the screening visit will be considered of insufficient quality. The central reading center
will make the final determination on sputum quality.
5. Patients who have history of intubation for asthma exacerbation within one year of the
screening visit.
6. Patients diagnosed with concurrent respiratory disease: presence of a known pre-existing,
clinically important lung condition other than asthma. This includes current infection,
bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of
emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than
asthma) or a history of lung cancer.
7. Recent history (i.e., within 6 months) of myocardial infarction or hospitalization for
cardiac failure during the past year.
8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a
history of thoracotomy for other reasons should be assessed as per Exclusion Criterion 1.
9. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the
year prior to screening or have planned procedures during the study.
10. Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone
(or equivalent) in the 6 weeks prior to screening visit.
11. Pregnant or nursing (lactating) women.
12. Women of childbearing potential that, if sexually active, are unwilling to use a highly
effective method of birth control which results in a low failure rate (i.e. less than 1% per
year) when used consistently and correctly from date of screening until 20 weeks after
last dosing with study medication in this trial. Highly effective methods of birth control
include: ethinyl estradiol containing contraceptives, diaphragm with spermicide
substance, intra-uterine device, and male sterilization.
Note: Women are considered post-menopausal and not of child bearing potential if
they have had 12 months of natural (spontaneous) amenorrhea with an appropriate
clinical profile, i.e. appropriate age range and history of vasomotor symptoms, or 6
months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for U.S.
add estradiol < 20 pg/mL]
13. Patients who have taken an investigational drug within 3 months or six half-lives
(whichever is greater) prior to the screening visit.
14. Patients who have been previously randomized in this study.
15. Chronic alcohol or drug abuse or any other condition that in the Investigator’s opinion
makes these patients unreliable or unlikely to complete the trial.
16. Clinically relevant acute infections or chronic infections including but not limited to HIV,
viral hepatitis, and (or) tuberculosis or evidence of tuberculosis infection as defined by a
positive QuantiFERON TB test within 2 months prior to or during screening.
Note: Subjects with a positive QuantiFERON TB test may participate in the study if
further work up (according to local practice/guidelines) establishes conclusively that
the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is
established, then treatment must have been initiated and maintained according to
local country guidelines.
17. Have received any live bacterial or live viral vaccination in the 12 weeks prior to the date
of screening. Patients must agree not to receive a live bacterial or live viral vaccination
during the study and up to 12 months after the last administration of study drug.
18. Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the
date of screening. Patients must agree not to receive BCG vaccination during the study
and up to 12 months after the last administration of study drug.
19. Have received treatment with; a) any dose of ustekinumab (Stelara®), or b) any other
biological based agents in the 3 months or within 6 times the half-life (whichever is
longer) prior to the screening visit.
1. Patients with a significant disease other than asthma. A significant disease is defined as a
disease which in the opinion of the Investigator may a) put the patient at risk because of
participation in the trial, or b) influence the results of the trial, or c) cause concern on the
patient’s ability to participate in the trial.
2. Patients with malignancy for which the patient has undergone resection, radiation, or
chemotherapy within the past 5 years. Patients with treated basal cell carcinoma or fully
cured squamous cell carcinoma are allowed.
3. Patients with clinically relevant abnormal hematology or blood chemistry laboratory
values at screening if the abnormality defines a significant disease as defined in Exclusion
Criterion 1.
4. Patients who are not able to produce sputum or sputum samples of sufficient quality at the
screening visit. Sputum samples with more than 40% squamous cells or low viability at
the screening visit will be considered of insufficient quality. The central reading center
will make the final determination on sputum quality.
5. Patients who have history of intubation for asthma exacerbation within one year of the
screening visit.
6. Patients diagnosed with concurrent respiratory disease: presence of a known pre-existing,
clinically important lung condition other than asthma. This includes current infection,
bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of
emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than
asthma) or a history of lung cancer.
7. Recent history (i.e., within 6 months) of myocardial infarction or hospitalization for
cardiac failure during the past year.
8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a
history of thoracotomy for other reasons should be assessed as per Exclusion Criterion 1.
9. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the
year prior to screening or have planned procedures during the study.
10. Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone
(or equivalent) in the 6 weeks prior to screening visit.
11. Pregnant or nursing (lactating) women.
12. Women of childbearing potential that, if sexually active, are unwilling to use a highly
effective method of birth control which results in a low failure rate (i.e. less than 1% per
year) when used consistently and correctly from date of screening until 20 weeks after
last dosing with study medication in this trial. Highly effective methods of birth control
include: ethinyl estradiol containing contraceptives, diaphragm with spermicide
substance, intra-uterine device, and male sterilization.
Note: Women are considered post-menopausal and not of child bearing potential if
they have had 12 months of natural (spontaneous) amenorrhea with an appropriate
clinical profile, i.e. appropriate age range and history of vasomotor symptoms, or 6
months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for U.S.
add estradiol < 20 pg/mL]
13. Patients who have taken an investigational drug within 3 months or six half-lives
(whichever is greater) prior to the screening visit.
14. Patients who have been previously randomized in this study.
15. Chronic alcohol or drug abuse or any other condition that in the Investigator’s opinion
makes these patients unreliable or unlikely to complete the trial.
16. Clinically relevant acute infections or chronic infections including but not limited to HIV,
viral hepatitis, and (or) tuberculosis or evidence of tuberculosis infection as defined by a
positive QuantiFERON TB test within 2 months prior to or during screening.
Note: Subjects with a positive QuantiFERON TB test may participate in the study if
further work up (according to local practice/guidelines) establishes conclusively that
the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is
established, then treatment must have been initiated and maintained according to
local country guidelines.
17. Have received any live bacterial or live viral vaccination in the 12 weeks prior to the date
of screening. Patients must agree not to receive a live bacterial or live viral vaccination
during the study and up to 12 months after the last administration of study drug.
18. Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the
date of screening. Patients must agree not to receive BCG vaccination during the study
and up to 12 months after the last administration of study drug.
19. Have received treatment with; a) any dose of ustekinumab (Stelara®), or b) any other
biological based agents in the 3 months or within 6 times the half-life (whichever is
longer) prior to the screening visit.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
300 participants
