Submitted by: N/A Last Updated by: 2013-08-22 16:13:09 Export to PDF

Study to evaluate over a prolonged period of time, the safety and the efficacy of a treatment with Reslizumab (at a dose of 3mg/kg) for patients suffering from eosinophilic asthma who completed a prior Cephalon-sponsored study in eosinophilic asthma.

PHRR130117-000043

Protocol No. C38072/3085; FDA RSN No. 12K-652

Unspecified

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Cephalon-Sponsored Study in Eosinophilic Asthma

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma, as assessed by the following: • adverse events throughout the study • clinical laboratory test (chemistry, hematology, and urinalysis) results at weeks 4, 8, and 24, and every 24 weeks thereafter throughout the study • brief physical examination findings at all visits (every 4 weeks) throughout the study • vital signs measurements every 4 weeks throughout the study • concomitant medication usage every 4 weeks throughout the study • measurement of anti-drug antibodies every 24 weeks throughout the study The secondary objectives of the study are to evaluate long-term efficacy of reslizumab as assessed by the following: • pulmonary function test results, as measured by forced expiratory volume in 1 second (FEV1), percent predicted forced expiratory volume in 1 second [%FEV1], forced vital capacity (FVC), and forced expiratory flow at 25% to75% FVC (FEF25 75%) every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • beta-agonist use every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • asthma symptom score (Asthma Symptom Utility Index [ASUI]) every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • Asthma Control Questionnaire (ACQ) every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • Asthma Quality of Life Questionnaire (AQLQ) every 24 weeks

Start Date Duration in Months Target Completion Date Actual Completion Date
2011-05-03 96 2019-05-03 0000-00-00

Ongoing

Institution Classification Region LTO #
PPD Development (S) PTE. LTD. Private Business NCR
Institution Classification Region LTO #
Teva Branded Pharmaceutical Products R & D, Inc. Private Business United States of America
Institution Amount Region
Teva Branded Pharmaceutical Products R & D, Inc. N/A United States of America
Name E-Mail Phone Number Postal Address
Fridee-May Ortega Fridee-May.Ortega@ppdi.com +632 6896516 9/F SunLife Centre 5th Avenue cor. Rizal Drive Bonifacio Global City Taguig City Philippines 1634
Name E-Mail Phone Number Postal Address
Dr. Joven Roque Gonong bonggonongmd@yahoo.com 09178264373 Lung Center of the Philippines, Quezon City
Name Expertise Affiliation
Joven Roque V. Gonong, MD Pulmonologist Lung Center of the Philippines
Project Location Institutional Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee

Treatment for patients with eosinophilic asthma

The safety of reslizumab will be assessed throughout the study by evaluating adverse events, clinical laboratory test results, vital signs measurements, brief physical examination findings, concomitant medication usage, and antibodies to reslizumab (immunogenicity) as follows: • Adverse events will be evaluated throughout the study • Chemistry, hematology, and urinalysis tests (except for urine β-HCG test conducted predose every 4 weeks) will be performed at baseline (end of treatment visit of previous double-blind study), at weeks 4, 8, and 24, and every 24 weeks thereafter until end of treatment visit, or early termination, and 90 days after the end of treatment visit. • Vital signs measurements, brief physical examinations, and concomitant medication usage will be assessed every 4 weeks throughout the study, and 90 days after the end of treatment visit. • Antibodies to reslizumab will be assessed every 24 weeks until end-of treatment visit/early termination

The efficacy measures and endpoints for this study are as follows: • Pulmonary function assessments (FEV1, %FEV1, FVC, FEF25-75%) assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit or last post baseline observation • Use of short-acting beta-agonists assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of treatment visit or last post baseline observation • ASUI assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit or last post baseline observation • ACQ assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit/early termination or last post baseline observation • AQLQ assessed every 24 weeks until end-of-treatment visit or last post baseline observation

Recruiting

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czech Republic
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Sweden
  • Taiwan
  • Thailand
  • Ukraine
  • United States

Clinical Trial

Unspecified

Unspecified

None

Patients are included in the study if all of the following criteria are met: (a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in India and Argentina; patients 66 through 75 years of age are excluded from participating in India. (b) Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards. (c) Patient must have completed treatment in a previous double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study. (d) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol. Patients are excluded from participating in this study if 1 or more of the following criteria are met: (a) The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety. (b) The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). (c) The patient is a current smoker. (d) The patient is expected to be poorly compliant with study drug administration, study procedures, or visits. (e) The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease [GERD]). (f) Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after the end of treatment visit. Acceptable methods of contraception include barier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). (g) The patient has a current infection or disease that may preclude assessment of asthma.

Interventional

Reslizumab

Solution for infusion, 3.0 mg/kg milligram(s)/kilogram

Non-randomized

Open-Label

Unspecified

Not Applicable

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma, as assessed by the following: • adverse events throughout the study • clinical laboratory test (chemistry, hematology, and urinalysis) results at weeks 4, 8, and 24, and every 24 weeks thereafter throughout the study • brief physical examination findings at all visits (every 4 weeks) throughout the study • vital signs measurements every 4 weeks throughout the study • concomitant medication usage every 4 weeks throughout the study • measurement of anti-drug antibodies every 24 weeks throughout the study The secondary objectives of the study are to evaluate long-term efficacy of reslizumab as assessed by the following: • pulmonary function test results, as measured by forced expiratory volume in 1 second (FEV1), percent predicted forced expiratory volume in 1 second [%FEV1], forced vital capacity (FVC), and forced expiratory flow at 25% to75% FVC (FEF25 75%) every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • beta-agonist use every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • asthma symptom score (Asthma Symptom Utility Index [ASUI]) every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • Asthma Control Questionnaire (ACQ) every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study • Asthma Quality of Life Questionnaire (AQLQ) every 24 weeks

Phase III

20

Unspecified

N/A

03 May 2011

Utilization Utilization Info
No records found.

Copyright © One Window Project 2018. All rights reserved.