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

Korábbi kezelés

• 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.

Más betegség

• 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.
• 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.

Laborértékek

• 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.
• Treatment with selected drugs known to have a substantial risk of QT prolongation in the past 30 days prior to the Screening Visit.
• Neutrophil count <2.000x109/L at the Screening Visit.
• 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.

Életkor

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

Egyéb

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

• 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 in accordance with the definition by the American Thoracic Society/European Respiratory Society
• Current or former smokers with a cigarette smoking history of ≥10 pack years at the Screening Visit calculated as (number of pack years = [number of cigarettes per day/20] multiplied by number of years smoked). Former smokers are defined as those who meet the pack-year history but have stopped smoking for at least 6 months prior to the Screening Visit.
• Spirometry: post-BD FEV1/FVC <0.70 and post-BD FEV1 >20% and ≤60% of predicted normal values at the Screening Visit.
• Documented history of exacerbation risk defined as exacerbation history of ≥1 moderate* 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 prior to enrollment with a stable dose of medication for ≥4 weeks prior to the Screening Visit.
• 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 the Screening and Baseline Visits.
• WOCBP (after menarche) must use e methods of birth control from the Screening Visit through the End of Study Visit..