A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
Status: | Terminated |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/23/2019 |
Start Date: | March 10, 2017 |
End Date: | February 22, 2018 |
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.
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).
- Additional criteria apply, please contact the investigator for more information
We found this trial at
34
sites
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