A Study to Assess the Effects of Dexpramipexole in Participants With Eosinophilic COPD

Exclusion Criteria

• •A current diagnosis of asthma or any history of asthma diagnosis when ≥40 years of age.
• •Significant pulmonary disease other than COPD (eg, α-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, lung cancer, clinically significant bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated eosinophil counts.
• •Pneumonia, upper or lower respiratory tract infection or acute exacerbation of COPD within 4 weeks prior to or during the Screening Phase.
• •Treatment with a biologic investigational drug in the last 5 months prior to the Screening Visit. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to the Screening Visit, whichever is longer. Treatment with GSK3511294 (long-acting anti-interleukin-5) in the past 12 months.
• •Treatment with any of the following monoclonal antibody therapies within 120 days prior to the Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
• •Treatment with pramipexole (Mirapex®) within 30 days of the Baseline Visit.
• •Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to the Screening Visit.
• •Treatment with selected drugs known to have a substantial risk of QT prolongation in the past 30 days prior to the Screening Visit.
• •Participants who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation.
• •History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 2 years prior to the Baseline Visit.
• •History of human immunodeficiency virus infection or chronic infection with hepatitis B or C.
• •Neutrophil count \<2.000x109/L at the Screening Visit.
• •Renal dysfunction, defined as an estimated glomerular filtration rate \<60 mL/min/1.73m2 at the Screening Visit (using the Chronic Kidney Disease Epidemiology Collaboration) formula.
• •Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at the Screening Visit confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart.
• •History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction \<25%.
• •Corrected QT interval by Fridericia (QTcF) interval \>450 ms for males and \>470 ms for females at the Screening Visit or QTcF ≥480 ms for participants with bundle branch block.
• •Pregnant women or women breastfeeding.
• •Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.