Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
12–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Severe asthma despite intensive follow-up by an asthma specialist for \>/=6 months prior to Visit 1
Baseline forced expiratory volume in 1 second (FEV1) \>/=40% of predicted prior to randomization
Receiving high doses of inhaled glucocorticosteroids at a total daily dose of \>/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
Chronic treatment with maintenance OCS for \>/=6 months prior to Visit 1
Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
You may not be if
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
For adolescents: History of active tuberculosis requiring treatment
Evidence of acute or chronic hepatitis or known liver cirrhosis
Known current malignancy or current evaluation for a potential malignancy
History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
Current smoker or former smoker with a smoking history of more than 15 pack-years
Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
Use of a licensed or investigational monoclonal antibody other than anti-interleukin (IL)-13 or anti-IL-4/IL-13, including but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study
Clareo Health | A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
