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

NCT06533553 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: AR-DEX-23-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 23

Brief Summary

This is an open-label Phase II study assessing the PD of dexpramipexole 150 mg twice daily (BID) in participants with eosinophilic COPD. This study will help characterize the profile and duration of reductions of blood absolute eosinophil counts (AEC).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Geometric mean change in the blood AEC from baseline to Week 16

  Baseline, Week 16

Secondary Outcomes (4)

• Pre-BD FEV1

  Baseline, Week 16

• Post-BD FEV1

  Baseline, Week 16

• St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)

  Baseline, Week 16

• COPD Assessment Test (CAT)

  Baseline, Week 16

Study Arms (1)

150 mg dexpramipexole BID

EXPERIMENTAL

150 mg dexpramipexole oral tablet taken twice a day

Drug: Dexpramipexole Dihydrochloride

Interventions

Dexpramipexole Dihydrochloride DRUG

Administration of dexpramipexole tablet

150 mg dexpramipexole BID

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Areteia Therapeutics: lead

Study Sites (23)

Research Site US-10001-017

Conway, Arkansas, 72032, United States

Location

Research Site US-10001-008

Newport Beach, California, 92663, United States

Location

Research Site US-10001-022

Northridge, California, 91324, United States

Location

Research Site US-10001-016

Westminster, California, 92683, United States

Location

Research Site US-10001-030

Orlando, Florida, 32803, United States

Location

Research Site 10001-032

Champaign, Illinois, 61820, United States

Location

Research Site US-10001-021

Hammond, Indiana, 46324, United States

Location

Research Site US-10001-033

Des Moines, Iowa, 50266, United States

Location

Research Site US-10001-020

Baltimore, Maryland, 21224, United States

Location

Research Site US-10001-024

Farmington Hills, Michigan, 48336, United States

Location

Research Site US-10001-005

Saint Charles, Missouri, 63301, United States

Location

Research Site US-10001-001

St Louis, Missouri, 63110, United States

Location

Research US-10001-010

Charlotte, North Carolina, 28277, United States

Location

Research Site US-10001-025

Charlotte, North Carolina, 28293, United States

Location

Research Site US-10001-007

Gastonia, North Carolina, 28054, United States

Location

Research Site US-10001-004

Columbus, Ohio, 43215, United States

Location

Research Site US-10001-002

DuBois, Pennsylvania, 15801, United States

Location

Research Site US-10001-013

Philadelphia, Pennsylvania, 19140, United States

Location

Research Site US-10001-023

East Providence, Rhode Island, 02914, United States

Location

Research Site US-10001-012

Rock Hill, South Carolina, 29732, United States

Location

Research Site US-10001-009

Corsicana, Texas, 75110, United States

Location

Research Site US-10001-038

Houston, Texas, 77030, United States

Location

Research Site 10001-026

McKinney, Texas, 75069, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard J Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: July 9, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)