Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: placebo; risankizumab
Intervention description: Matching placebo for risankizumab; Monoclonal IgG antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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.