An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
Condition: Asthma; Elevated Blood Eosinophils; Oral Corticosteroid Dependence
MeSH terms: Asthma
Intervention: Reslizumab; Placebo; Non-Oral Corticosteroid (non-OCS) Asthma Medication; Oral Corticosteroid (OCS)
Intervention description: Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.; Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.; Participants continue using their non-OCS background asthma medications without change during the study's treatment period.; After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.
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: 177.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Elevated Blood Eosinophils; Oral corticosteroid dependence; Reslizumab

Summary:

      The primary objective of the study is to determine the ability of reslizumab administered by
      subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral
      corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient is male or female, 12 years of age and older, with a previous diagnosis of
             asthma.

          2. Written informed consent is obtained.

          3. The patient requires daily maintenance dose of prednisone or equivalent for asthma of
             between 5 and 40 mg during the 3 months prior to screening.

          4. The patient has a documented elevated blood eosinophils at screening or during the
             previous 12 months.

          5. The patient has required high dose ICS plus another asthma controller for at least 6
             months prior to screening.

          6. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within
             the previous 24 months.

               -  Other criteria may apply, please contact the investigator for more information.

        Exclusion Criteria:

          1. The patient has any clinically significant, uncontrolled medical condition that would
             interfere with the study schedule or procedures and interpretation of efficacy results
             or would compromise the patient's safety.

          2. The patient has another confounding underlying lung disorder.

          3. The patient has a known hypereosinophilic syndrome.

          4. The patient has a history of any malignancy within 5 years of the screening visit,
             except for treated and cured non-melanoma skin cancers.

          5. The patient is pregnant or intends to become pregnant during the study or is
             lactating.

          6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.

          7. The patient is a current smoker or has a smoking history ≥10 pack-years.

          8. The patient is currently using any systemic immunosuppressive or immunomodulatory
             biologic except maintenance OCS for the treatment of asthma.

          9. The patient participated in a clinical study within 30 days or 5 half-lives of the
             investigational drug before screening, whichever is longer.

         10. The patient was previously exposed to benralizumab within 12 months of screening.

         11. The patient was previously exposed to reslizumab.

         12. The patient has a history of immunodeficiency disorder including human
             immunodeficiency virus.

         13. The patient has current suspected drug and/or alcohol abuse.

         14. The patient has had an active helminthic parasitic infection or was treated for one
             within 6 months of screening.

         15. The patient has a history of allergic reactions or hypersensitivity to any component
             of the study drug.

               -  Other criteria may apply, please contact the investigator for more information.