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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02452190
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : May 9, 2018
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Reslizumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : August 12, 2015
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Reslizumab

Arm Intervention/treatment
Experimental: 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

Primary Outcome Measures :
  1. Frequency of Clinical Asthma Exacerbations [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change in pre-bronchodilator FEV1 [ Time Frame: Baseline, week 52 ]
  2. Change in Asthma Quality of Life Questionnaire [ Time Frame: 52 weeks ]

  3. Change in Asthma Control Questionnaire [ Time Frame: Baseline, week 52 ]

  4. Change in total asthma symptom scores [ Time Frame: Baseline, Week 52 ]
  5. Percentage of asthma control days [ Time Frame: 52 weeks ]
  6. Change in St. George's Respiratory Questionnaire [ Time Frame: Baseline, week 32 ]
  7. Time to first clinical asthma exacerbation [ Time Frame: 52 weeks ]
  8. Frequency of exacerbations requiring hospitalization or emergency department visits [ Time Frame: 52 weeks ]
  9. Frequency of moderate exacerbations [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02452190

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Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc. Identifier: NCT02452190     History of Changes
Other Study ID Numbers: C38072-AS-30025
2015-000865-29 ( EudraCT Number )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents