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

Teva Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Eosinophils, Asthma

Treatments: Drug: reslizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03052725

C38072-AS-30066

2016-004661-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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391 participants in 1 patient group

reslizumab 110 mg

Experimental group

Description:

Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.

Treatment:

Drug: reslizumab