Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma
Brief Summary: This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.


Options:
A: Inclusion Criteria:

* Adult patients, 18 to 75 years of age at Visit 1
* Asthma diagnosis for \>/= 12 months prior to the start of screening (Visit 1)
* Bronchodilator response during screening
* Pre-bronchodilator FEV1 40%-80% of predicted during screening
* On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or equivalent for \>/= 6 months prior to the start of screening (Visit 1) with no anticipated changes throughout the study
* On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within the prescribed dosing range)
* Uncontrolled asthma as defined by protocol both during screening period and at time of randomization
* Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during screening period confirming the absence of other lung disease
* Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

* History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Use of zileuton or roflumilast within 6 months prior to screening
* Maintenance oral corticosteroid therapy, defined as daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to Visit 1
* Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within the 4 weeks prior to Visit 1
* Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral antibiotics within 2 weeks prior to Visit 1
* Active parasitic infection within the 6 months prior to Visit 1
* Active tuberculosis requiring treatment within the 12 months prior to Visit 1
* Known immunodeficiency, including, but not limited to, HIV infection
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
* Known malignancy or current evaluation for a potential malignancy
* Current smoker or former smoker with a history \>10 pack years
* History of alcohol, drug or chemical abuse
* Initiation or change in allergen immunotherapy within 3 months prior to Visit 1
* Use of biologic therapy including omalizumab during 6 months prior to Visit 1
* Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1
* Pregnant or lactating women
* Body mass index (BMI) \> 38 kg/m2
* Body weight \< 40 kg
B: Inclusion Criteria:

* Male or female subjects
* Age 18 to 65 years at the time of Screening
* Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2)
* Written informed consent obtained from the subject prior to performing any protocol related procedures, including Screening evaluations
* Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication
* Shows forced expiratory volume in 1 second (FEV1) reversibility postbronchodilator of greater than or equal to (\>=)12 percent and \>=200 milliliter (mL) or have shown such values in a previous test within the last year, or have a positive airway hyperresponsiveness (AHR) test result in the last year
* Pre-bronchodilator FEV 1 value \>=40 percent of individual predicted value at Visits 1 and 3
* Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding Screening, subjects should have a history of 1 or more of the following: Daytime asthma symptoms \>=2 days/week, Nighttime awakening \>=1 night/week, Salbutamol use \>=2 days/week
* An Asthma control questionnaire (ACQ) score \>=1.5 at Visits 1 and 3
* At least 1 occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter
* Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Day 1 through Study Day 169
* Otherwise healthy by medical history and physical examination for that age group
* A chest x-ray or computed tomography (CT) scan within the previous 12 months with no findings suggestive of acute or chronic respiratory pathology other than asthma
* Ability and willingness to complete the follow-up period until Day 169 as required by the protocol.

Exclusion Criteria:

* Known history of allergy or reaction to any component of the investigational product formulation
* Acute illness other than asthma at the start of the study
* History of an active infection within 4 weeks prior to Screening, or evidence of clinically significant active infection, including ongoing chronic infection
* History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to Screening
* Use of immunosuppressive medication (except oral prednisone up to 10 milligram/day (mg/day) and inhaled and topical corticosteroids) within 30 days before randomization into the study
* Receipt of immunoglobulin or blood products within 30 days before randomization into the study
* Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer
* History of any known immunodeficiency disorder
* A positive hepatitis B surface antigen, or hepatitis C virus antibody
* A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
* A live or attenuated vaccination received within 4 weeks prior to Screening
* Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
* History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
* Lactation (women)
* History of treatment for alcohol or drug abuse within the past year
* History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking \>=10 pack-years
* Evidence of any systemic disease on physical examination
* History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy less than or equal to (\<=)1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy \<=5 years prior to entry
* Known exposure to inhaled occupational agents or fumes
* Any condition (eg, cystic fibrosis \[CF\] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results
* Individuals who are legally institutionalized
* Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
C: Inclusion Criteria:

Severe persistent asthma with the following characteristics:

* Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
* Treated with high-dose inhaled corticosteroid (i.e. \> 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
* Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens

Exclusion Criteria:

* Current smokers or smoking history stopped for less than 3 years or \> 10 pack years.
* Asthma exacerbation during the 4 weeks prior to randomization.
* Active lung disease other than non-atopic asthma.
* Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
* Pregnant or nursing (lactating) women.
* Treatment with omalizumab.

Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:

* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
* Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
* MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575.
* Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., inhaled corticosteroids \[ICS\] or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study.
* Male or eligible female subjects:
* To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.
* A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.

Exclusion Criteria:

* Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
* Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
* Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). \[Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded\]
* Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
* Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
* ECG: Baseline ECG which has a clinically significant abnormality or which shows corrected QT interval with Fridericia (QTcF) \>=450 millisecond (msec) or QTcF \>=480 msec for subjects with Bundle Branch Block.
* Smoking status: Current smokers
* Liver Function: Liver function tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 : alanine transaminase (ALT) \>=2 x upper limit of normal (ULN); aspartate transaminase (AST) \>=2 x ULN; alkaline phosphatase \>=2 x ULN; Bilirubin \>1.5 x ULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%
* Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1
* ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575

Answer: B