Effects of Mepolizumab Compared to Placebo on Airway Physiology in Patients With Eosinophilic Asthma: MEMORY Study

NCT02594332 | Terminated Phase 3

• 2 other identifiers: 2015-0012015-001868-19
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on airway physiology in patients with eosinophilic asthma

Conditions

Asthma

Keywords

eosinophilic asthma; mepolizumab; treatment

Outcome Measures

Primary Outcomes (7)

• mean change from baseline in pre- and post-bronchodilator FVC at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator forced vital capacity (FVC) at visit 10 (week 24) and at time of response

  week 24 and time of response

• mean change from baseline in pre- and post-bronchodilator FEV1 at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) at visit 10 (week 24) and at time of response

  week 24 and time of response

• mean change from baseline in pre- and post-bronchodilator RV at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator residual volume (RV) at visit 10 (week 24) and at time of response

  week 24 and time of response

• mean change from baseline in pre- and post-bronchodilator TLC at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator total lung capacity (TLC) at visit 10 (week 24) and at time of response

  week 24 and time of response

• mean change from baseline in pre- and post-bronchodilator airway resistance at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator airway resistance at visit 10 (week 24) and at time of response

  week 24 and time of response

• mean change from baseline in pre- and post-bronchodilator IC at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator inspiratory capacity (IC) at visit 10 (week 24) and at time of response

  week 24 and time of response

• mean change from baseline in pre- and post-bronchodilator CO diffusion capacity at visit 10 (week 24) and at time of response

  The primary outcome is the mean change from baseline in pre- and post-bronchodilator CO diffusion capacity at visit 10 (week 24) and at time of response

  week 24 and time of response

Secondary Outcomes (33)

• Mean change from baseline in pre- and post-bronchodilator forced vital capacity (FVC) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)

  1, 3, 6, 9 and 12 months

• Mean change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)

  1, 3, 6, 9 and 12 months

• Mean change from baseline in pre- and post-bronchodilator residual volume (RV) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)

  1, 3, 6, 9 and 12 months

• Mean change from baseline in pre- and post-bronchodilator total lung capacity (TLC) over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)

  1, 3, 6, 9 and 12 months

• Mean change from baseline in pre- and post-bronchodilator airway resistance over the 48-week treatment period at prespecified timepoints (1, 3, 6, 9 and 12 months)

  1, 3, 6, 9 and 12 months

Study Arms (2)

Mepolizumab

EXPERIMENTAL

100 mg SC every 4 weeks for 13 injections

Drug: Mepolizumab

Placebo

EXPERIMENTAL

Amount of Placebo corresponding to mepolizumab dose SC every 4 weeks for 13 injections

Drug: Placebo

Interventions

Mepolizumab DRUG

100 mg SC every 4 weeks for 13 injections

Mepolizumab

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients must be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form.
• Male or female patients at least 18 years
• Physician-diagnosis of asthma and evidence of asthma as documented by either reversibility of airflow obstruction (FEV1 ≥ 12% or 200 ml) demonstrated at visit 1 or visit 2 .
• ICS dose must be ≥ 1000 μg/day BDP or equivalent daily with or without maintenance oral corticosteroids.
• Treatment in the past 12 months with an additional controller medication for at least 3 successive months, e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.
• Persistent airflow obstruction as indicated by a pre-bronchodilator FEV1 \< 80% predicted recorded at Visit 1 or \< 90% for patients on oral corticosteroids.
• An elevated peripheral blood eosinophil level of ≥ 300/µL that is related to asthma or ≥ 150/µL in patients treated with oral corticosteroids as maintenance therapy demonstrated at visit 1 or in the previous 12 months
• Confirmed history of two or more exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral), in the 12 months prior to visit 1, despite the use of high-dose inhaled corticosteroids. For patients receiving maintenance corticosteroids, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose.

You may not qualify if:

• Current smokers or former smokers with a smoking history of ≥ 10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked). Patients who have not smoked for ≥ 6 months before visit 1 and have \< 10 pack years can be included into the study.
• Presence of a clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
• Patients who have received omalizumab \[Xolair\] within 130 days of Visit 1.
• Patients who have received any biological to treat inflammatory disease within 5 half-lives of visit 1

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Pneumologie

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Stephanie Korn, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: November 3, 2015
• Study Start: November 17, 2015
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

DE (1)