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Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

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ClinicalTrials.gov Identifier: NCT02443298
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 13, 2015
Results First Submitted Date  ICMJE February 1, 2019
Results First Posted Date  ICMJE April 10, 2019
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE June 23, 2015
Actual Primary Completion Date October 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
Time to First Asthma Worsening During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]
  • Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period [ Time Frame: 24 weeks ]
  • Weekly Asthma Control Questionaire Score at Week 24 [ Time Frame: 24 weeks ]
  • Trough FEV1 in-clinic change from baseline at week 24 [ Time Frame: 24 weeks ]
  • Post-bronchodilator FEV1 in-clinic change from baseline at week 24 [ Time Frame: 24 weeks ]
  • Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
Official Title  ICMJE 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.
Brief Summary The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: placebo
    Matching placebo for risankizumab
  • Drug: risankizumab
    Monoclonal IgG antibody
    Other Names:
    • ABBV-066
    • BI 655066
Study Arms  ICMJE
  • 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).
    Intervention: Drug: risankizumab
  • 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).
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2017)
214
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
300
Actual Study Completion Date  ICMJE February 2, 2018
Actual Primary Completion Date October 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
  2. 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.
  3. Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
  4. Must have documented history of two or more severe asthma exacerbations in the last 12 months.

Exclusion criteria:

  1. Patients with a significant disease other than asthma.
  2. Patients who are not able to produce sputum or sputum samples of sufficient quality.
  3. Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
  4. Patients diagnosed with any concurrent respiratory disease.
  5. Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
  6. Patients who have undergone thoracotomy with pulmonary resection.
  7. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
  8. Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
  9. Pregnant or nursing women.
  10. Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
  11. Clinically relevant acute infections or chronic infections.
  12. Have received any live bacterial or live viral vaccination in the last12 weeks.
  13. Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
  14. Have received treatment with ustekinumab (Stelara®).
  15. Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Korea, Republic of,   Netherlands,   Poland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Hungary,   Ireland,   Italy
 
Administrative Information
NCT Number  ICMJE NCT02443298
Other Study ID Numbers  ICMJE 1311.14
2014-004932-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Boehringer Ingelheim
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account AbbVie
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP