A Study of Reslizumab Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma

Phase 1

• Conditions: ncontrolled Asthma & elevated blood Eosinophils; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-004661-23-PL
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Patients may only be included in the study if they meet all of the following criteria:

a. Written informed consent is obtained. A patient 12 through <18 years of age must provide assent, and their parent(s) or legal guardian(s) must provide consent.

b. Male or female patient 12 years or older with eosinophilic asthma who was previously randomized and completed the treatment period in either of the double-blind, placebocontrolled studies (Study 30025 or 30027) for sc reslizumab and who by the assessment of the Principal Investigator can safely participate in this study.

Adolescents from Study 30025 must also complete the early follow-up visit before being eligible for this study.

c. Unless surgically sterile or postmenopausal, female patients must have a negative urine pregnancy test at baseline. Definitions of sterile and postmenopausal are given in Protocol Appendix E.

d. Females of childbearing potential (not surgically sterile or postmenopausal) must have an exclusively same-sex partner or use a medically acceptable method of contraception and must agree to continue the use of this method for the duration of the study and for 5 months after discontinuation of the study drug. Acceptable methods of contraception include intrauterine device, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, bilateral tubal occlusion, and partner vasectomy.

e. The patient must be willing and able to comply with study restrictions and willing to return to the investigational center for the follow-up procedures and assessments as specified in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Patients will be excluded from participating in this study if they meet any of the following criteria:

a. Patient has received any intravenous or sc reslizumab administration in any previous clinical trial other than Studies 30025 and 30027.

b. Patient withdrew early (discontinued from treatment) from either of the placebocontrolled reslizumab studies, Studies 30025 and 30027, for any reason.

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

d. The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis eosinophilic granulomatosis with polyangiitis [also known as Churg-Strauss syndrome], or allergic bronchopulmonary
aspergillosis).

e. The patient has a known/diagnosed hypereosinophilic syndrome.

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

g. The patient is a pregnant or lactating woman or intends to become pregnant during the study or within 5 months after the last dose of study drug. Administration of IMP will be discontinued for any female patient who becomes pregnant during the study.

h. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening. (Note: This is required only in patients who did not rollover seamlessly from Study 30025 or 30027, ie, had a gap between placebo-controlled study
EOT and screening for Study 30066 [including adolescents from Study 30025 who must also complete the early follow-up visit].)

Patients who did not rollover seamlessly from Study 30025 or 30027 may be considered for rescreening if they are excluded from study participation for not satisfying this criterion. A patient may be rescreened for this reason 1 time only. The duration between
the first visit during the screening period and the rescreening must be >30 days.

i. The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history =10 pack-years.

j. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti-immunoglobulin E monoclonal antibody [mAb] or other mAb [eg, mepolizumab, benralizumab, dupilumab] or soluble receptors) or non-biologic (eg, methotrexate or cyclosporine), except maintenance oral corticosteroids for the treatment of asthma (up to and including 40 mg of prednisone daily or equivalent every-other-day dosing). Note: Previous use of such agents that occurred >5 half-lives from the initial screening visit may be allowed.

k. The patient participated in a clinical study other than approved Teva reslizumab studies within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.

l. The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

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

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

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

p. The patient is expected to be poorly compliant with study procedures or vis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to support the long-term safety of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma whose asthma is inadequately controlled on standard-of-care treatment.;Secondary Objective: The secondary objective of this study is to evaluate the efficacy of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma that is inadequately controlled on standard-of-care treatment.;Primary end point(s): The primary endpoint is the frequency of adverse events including serious adverse events.;Timepoint(s) of evaluation of this end point: Patient counts and percentages will be provided for the frequency of patients with at least 1 adverse event.