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

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. Identifier: NCT02443298
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : September 13, 2018
Boehringer Ingelheim
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Asthma Drug: ABBV-066 Drug: Placebo 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: 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.
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: ABBV-066
Single dose
Drug: ABBV-066
Monoclonal IgG Antibody
Other Names:
  • BI 655066
  • risankizumab

Placebo Comparator: Placebo Drug: Placebo
Matching placebo for ABBV-066

Primary Outcome Measures :
  1. Time to first asthma worsening during the planned 24 week treatment period [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Annualized rate of asthma worsening during the planned 24 week treatment period [ Time Frame: 24 weeks ]
  2. Annualized rate of severe asthma exacerbation during the planned 24-week treatment period [ Time Frame: 24 weeks ]
  3. Weekly Asthma Control Questionaire score at week 24 [ Time Frame: 24 weeks ]
  4. Trough FEV1 in-clinic change from baseline at week 24 [ Time Frame: 24 weeks ]
  5. Post-bronchodilator FEV1 in-clinic change from baseline at week 24 [ Time Frame: 24 weeks ]
  6. Time to first severe asthma exacerbation during the planned 24 week treatment period [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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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:

  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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02443298

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: AbbVie Identifier: NCT02443298     History of Changes
Other Study ID Numbers: 1311.14
2014-004932-20 ( EudraCT Number )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by AbbVie:
BI 655066

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases