A study to assess the safety and efficacy of subcutaneously administered BI 655066 as add-on therapy over 24 weeks in patients with severe persistent asthma.

What we are studying

You are being asked to participate in this study because you have severe asthma, a condition that causes wheezing, breathlessness, chest tightness and cough. Many people with severe asthma do not have their symptoms controlled even after taking current therapies that are available, and experience frequent asthma exacerbations also known as asthma attacks. The purpose of this study is to test the safety and efficacy (effectiveness) of the study drug BI 655066 administered by subcutaneous injections (i.e. injections beneath the skin) in adult subjects with severe asthma. This study will test whether the study drug will reduce exacerbation frequency, reduce episodes of asthma worsening, improve asthma symptoms, improve lung function, and resolve inflammation in the airways, and will test whether this is possible without posing unacceptable safety risks for subjects. We will also explore its pharmacokinetics (which shows how your body absorbs, breaks down, and removes the study drug in the blood). This study may also help to identify a biological marker that can be associated to people who respond favorably to this study drug. This is a study to test a new investigational drug, BI 655066. An investigational drug is one that is not approved for use in humans by the United States Food and Drug Administration (FDA). The use and/or formulation of BI 655066 is considered an investigational drug for the purposes of this study. This means that BI 655066 has not been FDA approved for severe asthma. BI 655066 belongs to a class of drugs known as monoclonal antibodies (mAB). This is a type of protein molecule produced in the laboratory that recognizes and attaches to specific proteins produced by cells in your body. In simple words, BI 655066 is expected to interact with other molecules in your body. This interaction may control certain biological mechanisms that are responsible for inflammation in chronic inflammatory diseases like asthma. BI 655066 is being investigated in research studies by the Sponsor in asthma and other diseases. The study doctor will prescribe rescue medication (used to relieve symptoms) such as ProAir HFA if needed for your asthma. The study doctor may also prescribe medications that you were taking before you enrolled in this study (also referred to as background medication).

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 75

Eligibility Criteria

  • You must be diagnosed with asthma
  • Using a moderate inhaled steroid with another controller medication
  • Have 2 episodes of worsening of asthma that required oral steroids or hospitalization
  • Be willing to have 2 bronchoscopies and a non smoker. You cannot have had cancer
  • No cannot be a pregnant or breastfeeding/lactating female
  • And you cannot have any other breathing issue.

What is involved

  • Demographics
  • Med. history/baseline conditions
  • Review smoking status
  • Physical examination (5 times)
  • Vital signs(every visit)
  • Laboratory assessments (12 times)
  • Pregnancy test5 (12 times)
  • 12-Lead resting ECG (7 times)
  • Induced sputum (5 times)
  • Feno measurements (12 times)
  • Administer AQLQ(S) (12 times)
  • Asthma worsening/exacerbation8 (every visit)
  • Medication washout check (12 times) Pulmonary function tests (11 times)
  • Pharmacogenomics (Biobanking) (once)
  • RNA expression samples (Blood) (4 times
  • Biomarker samples (12 times)
  • Pharmacokinetics samples (12 times)
  • Anti-Drug antibody samples (7 times)
  • Bronchoscopy (twice)
  • Adverse events check (every visit)

Compensation

For your travel and inconvenience related to your participation in this study, you will be paid up to a total of $1,275.00 if you complete this study. If you do not complete this study, for any reason, you will be paid for the study visits you do complete

Contact Information

Study Coordinator
Bob Hmieleski
Email
bhmieles@wfubmc.edu
Phone
336-713-8550
Principal Investigator
Euegen Bleecker, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.