A Study of Lebrikizumab in Patients With Severe Asthma Who Depend on Oral Corticosteroids (OCS)

Inclusion Criteria:

- Adults 12 to 75 years of age at the time of informed consent

- Severe asthma despite intensive follow-up by an asthma specialist for at least 6
months prior to Visit 1

- Baseline forced expiratory volume in 1 second (FEV1) at least 40% of predicted prior
to randomization

- Receiving high doses of inhaled glucocorticosteroids at a total daily dose of at
least 1500 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 at least 6 months prior to Visit 1

- Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal
effective or maximum tolerated dose with compliance

Exclusion Criteria:

- 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 >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