An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Elevated Blood Eosinophils; Asthma; Oral Corticosteroid Dependence

Treatments: Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication; Drug: Oral Corticosteroid (OCS); Drug: Placebo; Drug: Reslizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02501629

2015-001580-39 (EudraCT Number)

C38072-AS-30027

Details and patient eligibility

About

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Enrollment: 177 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.

2. Written informed consent is obtained.

3. The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.

4. The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.

5. The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.

6. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.

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

Exclusion criteria

1. The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.

2. The patient has another confounding underlying lung disorder.

3. The patient has a known hypereosinophilic syndrome.

4. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.

5. The patient is pregnant or intends to become pregnant during the study or is lactating.

6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.

7. The patient is a current smoker or has a smoking history ≥10 pack-years.

8. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.

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

10. The patient was previously exposed to benralizumab within 12 months of screening.

11. The patient was previously exposed to reslizumab.

12. The patient has a history of immunodeficiency disorder including human immunodeficiency virus.

13. The patient has current suspected drug and/or alcohol abuse.

14. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.

15. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.

    • Other 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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177 participants in 2 patient groups, including a placebo group

Reslizumab 110 mg

Experimental group

Description:

Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.

Treatment:

Drug: Oral Corticosteroid (OCS)

Drug: Reslizumab

Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication

Placebo

Placebo Comparator group

Description:

Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.

Treatment:

Drug: Oral Corticosteroid (OCS)

Drug: Placebo

Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication