An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.
Inclusion Criteria:
• Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)
~~ Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027.
The patient has any clinically significant, uncontrolled medical condition
The patient has another confounding underlying lung disorder
The patient has a known/diagnosed hypereosinophilic syndrome.
The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The patient is a pregnant or lactating woman
The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS
The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).