Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Reslizumab
Product Code: CEP-38072
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Reslizumab
CAS Number: 241473-69-8
Current Sponsor code: CEP-38072
Other descriptive n
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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, =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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 <lower limit of normal–2.0 g/dL). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of reslizumab in pediatric patients with asthma 6 to less than 12 years of age following administration of a single subcutaneous (sc) dose.;Secondary Objective: The secondary objectives of the study are to evaluate the immunogenicity, safety, and tolerability of reslizumab in pediatric patients with asthma 6 to less than 12 years of age following administration of a single sc dose.;Primary end point(s): Blood samples for eosinophil measurement and determination of serum reslizumab concentrations will be collected prior to and over 12 weeks after administration of reslizumab ;Timepoint(s) of evaluation of this end point: Days 1, 3, 7, 14, 28, 56, 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Blood samples to test for the presence of ADAs will be collected prior to and over 12 weeks after administration of reslizumab;Timepoint(s) of evaluation of this end point: Days 1, 14, 28, 56, 84 | — |
Countries
United States
Contacts
Public ContactProject Management
PPD
Outcome results
None listed