A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

• Status: Terminated
• Trial end date: 2018-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Reslizumab

Criteria

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).

• Additional criteria apply, please contact the investigator for more information