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

NCT03074942 | Completed Phase 2

• 1 other identifier: SEP-RES-2016-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Asthma Control Test score (ACT)

  Change in Asthma Control Test score (ACT) between baseline and week 24.

  Baseline and 24 weeks

Secondary Outcomes (11)

• Change from baseline in Asthma Control Test (ACT) score

  Baseline and 12 weeks

• Change from baseline in the 7-item Asthma Control Questionnaire (ACQ).

  Baseline and 24 weeks

• Percentage of patients that achieve the minimally important difference in ACT

  Baseline and 24 weeks

• Percentage of patients that achieve the minimally important difference in ACQ-7

  Baseline and 24 weeks

• Change from baseline in eosinophil count in peripheral blood.

  Baseline and 24 weeks

Study Arms (1)

Reslizumab

EXPERIMENTAL

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

Drug: Reslizumab

Interventions

Reslizumab DRUG

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

Reslizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of asthma-COPD (Chronic Obstructive Pulmonary Disease) overlap syndrome.
• Active and former smokers of\>10 packages / year.
• Exacerbations during the previous 4 weeks.
• 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.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (10)

Hospital Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

Location

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Virgen Del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Asthma

Interventions

reslizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luis Pérez de Llano, MD

  Hospital Universitario Lucus Augusti

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: April 20, 2017
• Primary Completion: March 26, 2018
• Study Completion: April 30, 2018
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)