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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02443298
First Posted: May 13, 2015
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie
May 11, 2015
May 13, 2015
October 19, 2017
June 2015
October 2017   (Final data collection date for primary outcome measure)
Time to first asthma worsening during the planned 24 week treatment period [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT02443298 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
A 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.
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: ABBV-066
    Monoclonal IgG Antibody
    Other Names:
    • BI 655066
    • risankizumab
  • Drug: Placebo
    Matching placebo for ABBV-066
  • Experimental: ABBV-066
    Single dose
    Intervention: Drug: ABBV-066
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
214
February 2018
October 2017   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Pre-bronchodilator clinic measured 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Hungary,   Ireland,   Korea, Republic of,   Netherlands,   Poland,   Taiwan,   United Kingdom,   United States
Italy
 
NCT02443298
1311.14
2014-004932-20 ( EudraCT Number )
Yes
Not Provided
Not Provided
AbbVie
AbbVie
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
AbbVie
October 2017

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