Mepolizumab as Add-on Treatment IN participants with COPD characterized by frequent Exacerbations and Eosinophil Level

JRCT ID: jRCT2031220621

Registered date:09/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COPD
• Date of first enrollment: 14/02/2023
• Target sample size: 800
• Countries of recruitment: Australia,Japan,New Zealand,Japan,Austria,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,India,Japan,Republic of Korea,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,UK,Japan,Canada,Japan,USA,Japan,Argentina,Japan,Brazil,Japan,China,Japan,Taiwan,Japan,Mexico,Japan
• Study type: Interventional
• Intervention(s): Mepolizumab 100 mg compared with placebo is given subcutaneously every 4 weeks as a liquid formulation in a pre-filled safety syringe injection. The study treatment period will be a minimum of 52 weeks up to a maximum of 104 weeks.

Outcome(s)

• Primary Outcome: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbations despite the use of optimized COPD maintenance therapy.
• Secondary Outcome: To evaluate mepolizumab 100 mg SC compared to placebo given every 4 weeks in liquid formulation by SS on additional efficacy assessments, health related quality of life (HRQoL), health care utilization, and symptoms

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-A peripheral blood eosinophil count of >=300 cells/uL from the hematology sample
collected at Screening Visit 0; AND A documented historical blood eosinophil count of >=150/uL in the 12 months prior to Screening Visit 0. Participants with no documented historical blood eosinophil count of >=150 cells/uL must meet this threshold based on the Screening Visit 1 assessment in order to return for Randomization Visit 2.
-Participants with a clinically documented history of COPD for at least 1 year
-A measured pre- and post-salbutamol FEV1/FVC ratio of <0.70 at Screening Visit 1
-A measured post-salbutamol FEV1>20% and <=80% of predicted normal values calculated using NHANES III reference equations at Screening Visit 1.
-Participants must have a well-documented history in the 12 months prior to Screening Visit 1 of:
Two or more moderate COPD exacerbations that were treated with systemic corticosteroids
OR
At least one severe COPD exacerbation requiring hospitalization
-Participants must have a well-documented requirement for optimized standard of care background therapy that includes ICS plus 2 additional COPD medications for the 12 months
prior to Screening Visit 1
-Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening

Exclude criteria

-Participants with a past history or concurrent diagnosis of asthma are excluded regardless of whether they have active or inactive disease.
-Participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
-Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening
-Participants with lung volume reduction surgery within the 12 months prior to Screening Visit 1.
-Participation in the acute phase of a pulmonary rehabilitation program
-Participants receiving treatment with oxygen more than 2 L/min at rest over 24 hrs.
-Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) >450 msec (or QTcF >480 msec in participants with bundle branch block).
-Participants with other conditions that could lead to elevated eosinophils

Related Information

• Primary Sponsor: Okamasa Arisa