Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils
Condition: Asthma
MeSH terms: Asthma
Intervention: Reslizumab; Placebo
Intervention description: Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.; Matching Placebo
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 468.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the effect of reslizumab (110 mg)
      administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and
      adolescents with asthma and elevated blood eosinophils who are inadequately controlled on
      standard-of-care asthma therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent is obtained.

          -  The participant is male or female, 12 years of age and older, with a diagnosis of
             asthma.

          -  The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility
             according to standard American Thoracic Society (ATS) or European Respiratory Society
             (ERS) protocol.

          -  The participant has required an inhaled corticosteroid.

          -  The participant has required an additional asthma controller medication besides
             inhaled corticosteroids.

          -  The participant has a history of asthma exacerbation.

          -  The participant must be willing and able to comply with study restrictions, perform
             requisite procedures and remain at the clinic for the required duration during the
             study period, and be willing to return to the clinic for the follow-up evaluation as
             specified in this protocol.

               -  Additional criteria may apply, please contact the investigator for more
                  information

        Exclusion Criteria:

          -  The participant has any clinically significant, uncontrolled medical condition
             (treated or untreated) that would interfere with the study schedule or procedures,
             interpretation of efficacy results, or compromise the patient's safety.

          -  The participant has another confounding underlying lung disorder

          -  The participant has a known hypereosinophilic syndrome.

          -  The participant has a diagnosis of malignancy within 5 years of the screening visit,
             except for treated and cured non-melanoma skin cancers.

          -  The participant is a pregnant or lactating woman, or intends to become pregnant during
             the study. Any woman becoming pregnant during the study will be withdrawn from the
             study.

          -  The participant is a current smoker or has a smoking history.

          -  The participated in a clinical trial within 30 days or 5 half-lives of the
             investigational drug before screening, whichever is longer.

          -  The participant was previously exposed to reslizumab.

          -  The participant has a history of an immunodeficiency disorder including human
             immunodeficiency virus (HIV).

          -  The participant has current or suspected drug and alcohol abuse.

          -  The participant has an active helminthic parasitic infection or was treated for one
             within 6 months of screening.

          -  The participant has a history of allergic reaction or hypersensitivity to any
             component of the study drug.

               -  Additional criteria may apply, please contact the investigator for more
                  information