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
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Asthma diagnosis for greater than or equal to (\>/=) 12 months prior to Visit 1
Bronchodilator response during screening
Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
On high dose ICS therapy for \>/= 6 months prior to Visit 1
On an eligible second controller medication for 6 months prior to Visit 1
Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
Demonstrated adherence with controller medication during the screening period
You may not be if
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 prior to 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 that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 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
History of active tuberculosis requiring treatment
Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
Evidence of acute or chronic hepatitis or known liver cirrhosis
History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
Diagnosis or history of 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 (whichever is longer) prior to Visit 1
Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
History of bronchial thermoplasty
Clareo Health | A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
