A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication | NCT01868061 | Trialant

A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication | NCT01868061 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Asthma diagnosis for greater than equal to (>/=) 12 months at Visit 1

Bronchodilator response at Visit 1, 2, or 3

Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3

On ICS therapy at a total daily dose of 500-2000 microgram (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1

On an eligible second controller medication (long-acting Beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1

Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3

Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease

Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection

Maintenance oral corticosteroid therapy within 3 months of Visit 1

Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period

Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study

Infection requiring hospital admission for >/=24 hours or requiring treatment with IV or 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

Active tuberculosis requiring treatment within 12 months prior to Visit 1

Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection

Evidence of acute or chronic hepatitis or known liver cirrhosis

History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma

Known current malignancy or current evaluation for potential malignancy

Current smoker or former smoker with a history of greater than (>) 10 pack-years

History of alcohol or drug abuse

Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening

Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening