study to evaluate the safety and efficacy of cat-354

Conditions: Asthma

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.

study mi-cp199, a phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of 3 sc treatment regimens of cat-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.

Eligibility criteria:
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.

Keywords: cat-354 tralokinumab asthma