A Single-Dose, Open-Label, Parallel Group Study to Characterize the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of Reslizumab Following Subcutaneous Administration in Children with Asthma (6 to Less Than 12 Years of Age)
- Conditions
- AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-002060-40-Outside-EU/EEA
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 36
a. Written informed consent (signed and dated) is provided by parent(s)/guardian(s) (in accordance with local regulations) before conducting any study-related procedure. Written informed assent is to be provided by children.
b. The patient has a body weight within 2 standard deviations (SDs) from the mean for their age and sex.
c. The patient is 6 to less than 12 years old with a current diagnosis of asthma.
d. The patient has been taking an inhaled corticosteroid or leukotriene inhibitor (eg, montelukast) for at least 30 days prior to screening. Patients are allowed to be on additional asthma controllers (eg, long acting ß-agonist).
e. The patient is in otherwise good health (except for the diagnosis of asthma).
f. The patient has a blood eosinophil level of at least 150 x 106/L at screening.
g. Female patients who are postmenarche or sexually active must have a negative pregnancy test result, must have exclusively same sex partners or be using a highly effective method of birth control, and must agree to continued use of this method for 30 days prior to the study, for the duration of the study, and for 5 months after the dose of study drug. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (ie, <1% per year) when used consistently and correctly. Highly effective methods of birth control in this study include: combined (estrogen and progestogen containing) or progestogen only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, and sexual abstinence.
h. The patient has negative alcohol test and urine drug screen (UDS) results. A positive UDS result with appropriate medical explanation may be permitted after consultation with the medical monitor.
I. The patient and parent(s)/guardian(s) are willing and able to comply with all study restrictions, perform required procedures, report to the study center for the required visits and remain at the study center for the required durations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
a. The patient has any clinically significant medical history or current uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of results, or compromise the patient’s safety. This includes clinically uncontrolled asthma, in the judgment of the investigator.
b. The patient is anemic (hemoglobin c. The patient has known hypereosinophilic syndrome.
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], allergic bronchopulmonary aspergillosis, or autoimmune disease).
e. The patient has a history of near-fatal asthma (an episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures) at any time in the past.
f. The patient is currently using any systemic immunosuppressive treatment or immunomodulatory biologic (eg, anti-IgE monoclonal antibody, other monoclonal antibodies or soluble receptors), non biologic (eg, methotrexate, cyclosporine, or maintenance oral corticosteroids), or allergen immunotherapy.
g. The patient has received an investigational drug within 30 days or 5 half-lives prior to the dose of study drug. For a new chemical entity or biologic product, the patient has received the product within 3 months or 5 half-lives prior to the dose of study drug, whichever is longer.
h. The patient has a positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus.
i. The patient has an active helminthic parasitic infection or was treated for one within 6 months prior to screening. Patients who live with anyone that currently has a helminthic parasitic infection or was treated for one within 6 months are also excluded.
j. The patient has a known or suspected hypersensitivity or idiosyncratic reaction to anti interleukin 5 (anti-IL-5) antibodies, any compound present in the study drug, or monoclonal antibodies.
k. The patient has previously been exposed to reslizumab or any other anti IL 5 treatment.
l. The patient is, in the opinion of the investigator or designee, considered unsuitable or unlikely to comply with the study protocol for any other reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method