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

Inclusion Criteria:

• Signed informed consent form prior to any study-specific procedures.

• Male or female ≥40 to ≤80 years of age at Screening Visit.

• Physician diagnosis of COPD for at least 2 years prior to the Screening Visit inaccordance with the definition by the American Thoracic Society/European RespiratorySociety

• Current or former smokers with a cigarette smoking history of ≥10 pack years at theScreening Visit calculated as (number of pack years = [number of cigarettes perday/20] multiplied by number of years smoked). Former smokers are defined as thosewho meet the pack-year history but have stopped smoking for at least 6 months priorto the Screening Visit.

• Spirometry: post-BD FEV1/FVC <0.70 and post-BD FEV1 >20% and ≤60% of predictednormal values at the Screening Visit.

• Documented history of exacerbation risk defined as exacerbation history of ≥1moderate* or ≥1 severe** within 2 years prior to the Screening Visit.

• Background ICS-based therapy (ICS+ long-acting β2 agonist [LABA], or ICS +long-acting muscarinic antagonist [LAMA], or ICS + LAMA + LABA) for ≥12 weeks priorto enrollment with a stable dose of medication for ≥4 weeks prior to the ScreeningVisit.

• Evidence of an eosinophilic phenotype: Participants with blood eosinophils ≥0.30x109/L at the Screening Visit.

• Negative urine pregnancy test for women of childbearing potential (WOCBP) at theScreening and Baseline Visits.

• WOCBP (after menarche) must use e methods of birth control from the Screening Visitthrough the End of Study Visit..

Exclusion Criteria:

• A current diagnosis of asthma or any history of asthma diagnosis when ≥40 years ofage.

• 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 diseaseassociated with elevated eosinophil counts.

• Pneumonia, upper or lower respiratory tract infection or acute exacerbation of COPDwithin 4 weeks prior to or during the Screening Phase.

• Treatment with a biologic investigational drug in the last 5 months prior to theScreening 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 daysprior 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 thepast 30 days prior to the Screening Visit.

• Treatment with selected drugs known to have a substantial risk of QT prolongation inthe past 30 days prior to the Screening Visit.

• Participants who are participating in the acute phase of a pulmonary rehabilitationprogram, ie, who started rehabilitation.

• History of malignancy that required surgery (excluding local and wide-localexcision), radiation therapy and/or systemic therapy during the 2 years prior to theBaseline Visit.

• History of human immunodeficiency virus infection or chronic infection withhepatitis B or C.

• Neutrophil count <2.000x109/L at the Screening Visit.

• Renal dysfunction, defined as an estimated glomerular filtration rate <60mL/min/1.73m2 at the Screening Visit (using the Chronic Kidney Disease EpidemiologyCollaboration) formula.

• Active liver disease defined as any known current infectious, neoplastic, ormetabolic pathology of the liver or unexplained elevations in alanineaminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit ofnormal (ULN), or total bilirubin >2x ULN at the Screening Visit confirmed by arepeat 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 leftventricular ejection fraction <25%.

• Corrected QT interval by Fridericia (QTcF) interval >450 ms for males and >470 msfor females at the Screening Visit or QTcF ≥480 ms for participants with bundlebranch block.

• Pregnant women or women breastfeeding.

• Males who are unwilling to use an acceptable method of birth control during theentire study period (ie, condom with spermicide).

• The above information is not intended to contain all considerations relevant to apatient's potential participation in a clinical trial.