Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab

May 10, 2018 updated by: Sociedad Española de Neumología y Cirugía Torácica

Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab: a Pilot Study

Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital de Sabadell
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Hospital Universitario de Cruces
    • Islas Baleares
      • Palma, Islas Baleares, Spain, 07120
        • Hospital Universitari Son Espases
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 18 and 70 years of age,
  • Patients diagnosed with severe uncontrolled asthma
  • Patients who give informed consent.
  • Previous treatment with omalizumab that was discontinued because lack of efficacy (symptoms -ACT <20, exacerbations) or adverse effects.
  • Patients with a high blood eosinophil count (400 μl) at least once in the previous 3 years.
  • Women should be surgically sterilized, at least 2 years have passed since menopause, or must have a negative pregnancy test within 7 days prior to initiation of treatment.
  • Women of childbearing potential (not surgically sterilized or menopausal for less than 2 years) should use a medically accepted method of contraception and should agree to continue using this method during the study and at least 30 days after the end of the study.
  • Patient should be willing and able to comply with the study restrictions and attend the visits indicated in the protocol to carry out the follow-up evaluations detailed in the protocol.

Exclusion Criteria:

  • Diagnosis of asthma-COPD (Chronic Obstructive Pulmonary Disease) overlap syndrome.
  • Active and former smokers of>10 packages / year.
  • Exacerbations during the previous 4 weeks.
  • Current treatment with omalizumab or last dose of omalizumab in the 5 months prior to inclusion of the patient in the study. 5- Exposure to another monoclonal antibody.
  • Participation in another clinical trial.
  • Uncontrolled clinically significant disease, which may interfere with study procedures, interpretation of efficacy results, or compromise patient safety.
  • Underlying lung disorder.
  • Known hypereosinophilic syndrome.
  • A pregnant or lactating woman, or who intends to become pregnant during the study.
  • Participation in a clinical trial within 30 days prior to the start of treatment.
  • Previous exposure to reslizumab or other anti-IL-5 monoclonal antibody.
  • Immunodeficiency disorder, including HIV.
  • Suspected drug or alcohol abuse.
  • Active helminth parasite infection or for which treatment was received in the 6 months prior to the start of treatment.
  • History of allergic reaction or hypersensitivity to any component of the study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Reslizumab
Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks
Drug: Reslizumab
Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Asthma Control Test score (ACT)
Time Frame: Baseline and 24 weeks
Change in Asthma Control Test score (ACT) between baseline and week 24.
Baseline and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Asthma Control Test (ACT) score
Time Frame: Baseline and 12 weeks
Change in ACT between baseline and week 12
Baseline and 12 weeks
Change from baseline in the 7-item Asthma Control Questionnaire (ACQ).
Time Frame: Baseline and 24 weeks
Change in the 7-item ACQ between baseline and week 24.
Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACT
Time Frame: Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACT (increase of at least 3 ponints) at week 24
Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACQ-7
Time Frame: Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACQ-7 (reduction of at least 0.5 ponints) at week 24
Baseline and 24 weeks
Change from baseline in eosinophil count in peripheral blood.
Time Frame: Baseline and 24 weeks
Change from baseline in eosinophil count in peripheral blood at week 24.
Baseline and 24 weeks
Change from baseline in lung function (FEV1).
Time Frame: Baseline and 24 weeks
Change from baseline in lung function (FEV1) at week 24.
Baseline and 24 weeks
Number of severe exacerbations of asthma.
Time Frame: 24 weeks
Number of severe exacerbations of asthma during the 24 weeks of the study.
24 weeks
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score.
Time Frame: Baseline and 24 weeks
Change from baseline in the AQLQ questionnaire score at week 24.
Baseline and 24 weeks
Change from baseline in exhaled nitric oxide levels.
Time Frame: Baseline and 24 weeks
Change from baseline in exhaled nitric oxide levels at week 24.
Baseline and 24 weeks
Number of participants with adverse events
Time Frame: 24 weeks
Number of participants with adverse events
24 weeks
Number of participants with severe adverse events
Time Frame: 24 weeks
Number of participants with severe adverse events
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sociedad Española de Neumología y Cirugía Torácica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Teva Pharmaceuticals USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Luis Pérez de Llano, MD, Hospital Universitario Lucus Augusti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEP-RES-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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