Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Reslizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452190

2015-000865-29 (EudraCT Number)

C38072-AS-30025

Details and patient eligibility

About

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

Enrollment: 468 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent is obtained.

• The participant is male or female, 12 years of age and older, with a diagnosis of asthma.

• The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.

• The participant has required an inhaled corticosteroid.

• The participant has required an additional asthma controller medication besides inhaled corticosteroids.

• The participant has a history of asthma exacerbation.

• The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

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

Exclusion criteria

• The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.

• The participant has another confounding underlying lung disorder

• The participant has a known hypereosinophilic syndrome.

• The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.

• The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.

• The participant is a current smoker or has a smoking history.

• The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.

• The participant was previously exposed to reslizumab.

• The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

• The participant has current or suspected drug and alcohol abuse.

• The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.

• The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 2 patient groups, including a placebo group

Reslizumab

Experimental group

Description:

Reslizumab

Treatment:

Drug: Reslizumab

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo