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Study of Reslizumab in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT02452190
First received: May 13, 2015
Last updated: December 1, 2016
Last verified: December 2016
  Purpose
The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

Condition Intervention Phase
Asthma
Drug: Reslizumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Frequency of Clinical Asthma Exacerbations [ Time Frame: 52 weeks ]
    Spirometry


Secondary Outcome Measures:
  • Change in FEV1 [ Time Frame: Baseline, week 52 ]
  • Change in Asthma Quality of Life Questionnaire [ Time Frame: 52 weeks ]
    Composite

  • Change in Asthma Control Questionnaire [ Time Frame: Baseline, week 52 ]
    Composite

  • Percentage of Participant with Adverse Events [ Time Frame: 52 weeks ]
  • Change in total asthma symptom scores [ Time Frame: Baseline, Week 52 ]
  • Asthma control days [ Time Frame: 52 weeks ]
  • Change in St. George's Respiratory Questionnaire [ Time Frame: Baseline, week 32 ]
  • Time to first clinical asthma exacerbation [ Time Frame: 52 weeks ]
  • Frequency of exacerbations requiring hospitalization or emergency department visits [ Time Frame: 52 weeks ]
  • Frequency of moderate exacerbations [ Time Frame: 52 weeks ]

Enrollment: 469
Study Start Date: September 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab
Reslizumab
Drug: Reslizumab
Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent is obtained.
  • The patient is male or female, 12 years of age and older, with a diagnosis of asthma.
  • The patient has FEV1 reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
  • The patient has required an inhaled corticosteroid.
  • The patient has required an additional asthma controller medication besides inhaled corticosteroids.
  • the patient has a history of asthma exacerbation.
  • The patient must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

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

Exclusion Criteria:

  • The patient has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
  • The patient has another confounding underlying lung disorder
  • The patient has a known hypereosinophilic syndrome.
  • The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
  • The patient is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
  • The patient is a current smoker or has a smoking history.
  • The patient participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
  • The patient was previously exposed to reslizumab.
  • The patient has a history of an immunodeficiency disorder including HIV.
  • The patient has current or suspected drug and alcohol abuse.
  • The patient has an active helminthic parasitic infection or was treated for one within 6 months of screening.
  • The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.

    • Additional criteria may apply, please contact the investigator for more information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02452190

  Show 200 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
PPD
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02452190     History of Changes
Other Study ID Numbers: C38072-AS-30025
2015-000865-29 ( EudraCT Number )
Study First Received: May 13, 2015
Last Updated: December 1, 2016

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 25, 2017