Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled,Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple-Dose Subcutaneous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody,When Administered to Adults With Mild Persistent Asthma
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.


Options:
A: 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.
B: Inclusion Criteria:

* Both body weight and total serum IgE suitable for omalizumab dosing.
* Diagnosis of asthma made by a physician more than 1 year prior to study entry OR diagnosis of asthma made less than 1 year prior to study entry but have had asthma symptoms for longer than 1 year prior to study entry
* Are receiving long-term asthma control therapy OR have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease
* Positive prick skin test to at least one perennial allergen (e.g., dust mite, cockroach, mold, cat, dog, rat, mouse)
* Live in a preselected zip code are
* Able to perform spirometry measurements
* Willing to sign informed consent or have parent or guardian willing to provide informed consent
* Previously had chicken pox or received varicella (chicken pox) vaccine
* Have some form of health care insurance that covers costs of medications

Exclusion Criteria:

If participant meets any of these criteria, they are not eligible at that time but may be reassessed:

* Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2
* Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study entry
* Pregnancy or breastfeeding
* Acute sinusitis or chest infection requiring antibiotics within 1 month of study screening
* Currently participating in another asthma-related clinical trial or have previously participated in an another asthma-related trial within 1 month of study entry
* Does not sleep at least 4 nights per week in one home
* Lives with a foster parent
* Does not have access to a phone
* Plans to move during the study
* Previously treated with anti-IgE therapy within 1 year of study entry
* Currently receiving or received hyposensitization therapy to any allergen in the year prior to study entry
* Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach for more than 6 months in the 3 years prior to study entry

If participant meets any of these criteria, they are not eligible for the study and may not be reassessed:

* Significant medical illness. More information on this criterion can be found in the protocol.
* Certain medications within 4 weeks of study screening. More information on this criterion can be found in the protocol.
* Known hypersensitivity to any ingredients of omalizumab or related drugs
* Diagnosis of cancer, being investigated for possible cancer, or history of cancer
* Will not allow study physician to manage their asthma
* Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)
* History of severe anaphylactoid or anaphylactic reaction(s)
C: Inclusion Criteria:

* Male or female adults, age 18 through 65 years of age at time of screening;
* Weight ≤ 100 kg and body mass index ≤ 35;
* Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
* Previously documented diagnosis of asthma based on episodic symptoms of airflow obstruction such as wheezing or chest tightness, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
* Currently receiving treatment with short-acting β2 agonists, ICS at doses ≤ 264 μg/day fluticasone or equivalent, or both (National Heart, Lung, and Blood Institute \[NHLBI\], 2002);
* FEV1 or peak expiratory flow (PEF) ≥ 80% of predictable value;
* Have had a diagnosis of mild persistent asthma, defined as having asthma symptoms with a frequency of more than twice a week but less than once daily, or nighttime symptoms with a frequency of more than twice a month but less than once a week (NHLBI, 2002);
* Have AHR based on documented clinical history of either methacholine inhalation challenge with PC20 ≤ 16 mg/mL or partial reversibility of ≤ 12% in FEV1 within the past 18 months (including screening);
* Able to provide spirometry readings that meet American Thoracic Society/European Respiratory Society standards (Miller, 2005);
* Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, implanted, or transdermal contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 150;
* Ability to complete the study period, including follow-up period, of up to 150 days; and
* Willing to forego other forms of experimental treatment and study procedures during the study.

Exclusion Criteria:

* Receipt of MEDI-528 in any previous clinical study or prior randomization into the trial;
* History of allergy or reaction to any component of the MEDI-528 formulation;
* Lung disease other than persistent asthma (e.g. chronic bronchitis);
* FEV1 \< 80% of predicted values;
* History of severe asthma or asthma exacerbation requiring intubation;
* Use of systemic immunosuppressive drugs including systemic corticosteroids or ICS with doses \> 264 μg/day fluticasone or equivalent within 4 weeks prior to Study Day 0;
* Use of long-acting β2 agonists, theophylline, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, or any other inhaled or systemic medication for asthma (except short-acting β2 agonists or ICS at doses ≤ 264 μg/day fluticasone or equivalent) within the 2 weeks prior to Study Day 0;
* Current use of any β-adrenergic antagonist (e.g., propranolol);
* Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period;
* Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) at screening and up through time of the first dose of study drug;
* Current allergy vaccination therapy (desensitization immunotherapy), with less than 3 months of stable maintenance doses prior to screening;
* Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
* Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
* Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
* Lactating or breastfeeding woman;
* Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus-1 or -2 (HIV-1 or HIV-2), or active infection with hepatitis A;
* History of significant systemic disease (e.g., cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
* History of cancer other than non-melanoma skin cancer or cervical carcinoma-in-situ treated with apparent success with curative therapy (remission for ≥ 1 year prior to screening);
* History of primary immunodeficiency;
* History of pancreatitis;
* History of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to randomization or history of smoking of ≥ 10 pack-years;
* Elective surgery planned during the study period through Study Day 150;
* Clinically significant abnormalities on physical examination (other than asthma) prior to the first dose of study drug (including but not limited to splenomegaly); Clinically significant abnormality, as determined by the investigator, on 12-lead ECG, MRI, or chest radiograph at the time of screening;
* At the time of screening, any abnormality of the following measurements: hemoglobin, total white blood cell count (WBC), platelet count, aspartate transaminase (AST), alanine transaminase (ALT), amylase, or serum creatinine above the upper limits of normal (ULN); or other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator, are judged to be clinically significant;
* Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or
* Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
D: Inclusion Criteria:

* Adults aged \>= 18 years.
* Patients with severe persistent allergic asthma with the following characteristics:
* FEV1 (Forced Expiratory Volume in One Second) \<80% of predicted.
* Frequent daily symptoms (\>=4 days/week on average) or nocturnal awakening (\>=1/week on average).
* Multiple severe asthma exacerbations: either \>=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
* Despite a high dose inhaled corticosteroid \>1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
* With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
* Total serum IgE level \>= 30 to \<=700 IU/ml and suitable serum total IgE level and weight according to Xolair dosing tablets.

Exclusion Criteria:

* Age \< 18 years.
* Smoking history \> 20 pack years.
* Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
* History of food or drug related severe anaphylactoid or anaphylactic reaction
* Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
* Patients with active cancer, suspicion of cancer or any history of cancer.
* Pregnant women.
* Known hypersensitivity to omalizumab or to one of its components.
* Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
* Patients who had participated in a clinical trial in the past 3 months.

Answer: C