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Completed

NCT Number: NCT03074942

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

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.

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitari Son Espases, Palma, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reslizumab

Drug

Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from baseline in Asthma Control Test (ACT) score

    Time frame: Baseline and 12 weeks

    Change in ACT between baseline and week 12

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. Change from baseline in lung function (FEV1).

    Time frame: Baseline and 24 weeks

    Change from baseline in lung function (FEV1) at week 24.

  7. Number of severe exacerbations of asthma.

    Time frame: 24 weeks

    Number of severe exacerbations of asthma during the 24 weeks of the study.

  8. 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.

  9. 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.

  10. Number of participants with adverse events

    Time frame: 24 weeks

    Number of participants with adverse events

  11. Number of participants with severe adverse events

    Time frame: 24 weeks

    Number of participants with severe adverse events

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Collaborators

  • Teva Pharmaceuticals USA

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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