Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
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| ClinicalTrials.gov Identifier: NCT02443298 |
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Recruitment Status :
Completed
First Posted : May 13, 2015
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: placebo Drug: risankizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 214 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma. |
| Actual Study Start Date : | June 23, 2015 |
| Actual Primary Completion Date : | October 13, 2017 |
| Actual Study Completion Date : | February 2, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Risankizumab
Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).
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Drug: risankizumab
Monoclonal IgG antibody
Other Names:
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Placebo Comparator: Placebo
Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20).
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Drug: placebo
Matching placebo for risankizumab |
- Time to First Asthma Worsening During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]
Time to first asthma worsening during the planned 24 week treatment period:
Asthma worsening was defined as the occurrence of any one of the following four criteria:
a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days 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 was considered a severe asthma exacerbation.
- Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition [ Time Frame: 24 weeks ]
Time to first asthma worsening during the planned 24 week treatment period according to alternative definition:
Asthma worsening was defined as the occurrence of any one of the following four criteria:
a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.5 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days 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 was considered a severe asthma exacerbation.
- Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]
Annualized rate of asthma worsening during the planned 24 week treatment period.
Asthma worsening was defined as the occurrence of any one of the following four criteria:
a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days 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 was considered a severe asthma exacerbation.
Mean is Annualized rate.
- Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]Time to first severe asthma exacerbation during the planned 24 week treatment period. Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days 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 was considered a severe asthma exacerbation.
- Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period [ Time Frame: 24 weeks ]
Annualized rate of severe asthma exacerbation during the planned 24-week treatment period.
Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days 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 was considered a severe asthma exacerbation.
Mean is Annualized rate.
- Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24 [ Time Frame: Baseline and 24 weeks ]Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24 [ Time Frame: Baseline and 24 weeks ]Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
- Weekly Asthma Control Questionaire Score at Week 24 [ Time Frame: 24 weeks ]The score at week 24 is the average of the responses to the five ACQ5 questions for the week preceding the Week 24 visit. The ACQ5 asks patients to rate the severity of their asthma symptoms and the degree to which asthma affected their sleep and other daily activities. The scale for all five ACQ5 questions range from the best possible answer of 0 (No symptoms, None, Never) to the worst possible answer of 6 (very severe, unable to sleep, totally limited). The ACQ5 score can range from 0.0 (best) to 6.0 (worst).
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
- One year history of asthma diagnosed by a physician, and have FEV1 reversibility of =12% and an absolute change of at least 200 mL after administration of 400 µg salbutamol.
- Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
- Must have documented history of two or more severe asthma exacerbations in the last 12 months.
Exclusion criteria:
- Patients with a significant disease other than asthma.
- Patients who are not able to produce sputum or sputum samples of sufficient quality.
- Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
- Patients diagnosed with any concurrent respiratory disease.
- Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
- Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
- Pregnant or nursing women.
- Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
- Clinically relevant acute infections or chronic infections.
- Have received any live bacterial or live viral vaccination in the last12 weeks.
- Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
- Have received treatment with ustekinumab (Stelara®).
- Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443298
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| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Documents provided by AbbVie:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02443298 |
| Other Study ID Numbers: |
1311.14 2014-004932-20 ( EudraCT Number ) |
| First Posted: | May 13, 2015 Key Record Dates |
| Results First Posted: | April 10, 2019 |
| Last Update Posted: | April 10, 2019 |
| Last Verified: | March 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |