This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Treatment failure rate
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.
Time frame: 28 days
Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
Time frame: 28 days
Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
Time frame: 28 days
Mean change from baseline (CFB) in EXACT-PRO score
Mean CFB in clinical respiratory symptoms of COPD using the E-RS: COPD (Evaluating Respiratory Symptoms in COPD) comprised in the EXACT-PRO through Week 1, Week 2, and Week 4. The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome (EXACT-PRO) is a PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in patients with COPD.
Time frame: Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1 at Day 3, Week 1, and Week 4
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Day 3, Week 1, and Week 4
Time frame: Day 3, Week 1, and Week 4
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
Time frame: 56 days
Incidence of unanticipated adverse device effects (UADEs)
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University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, United States
RECRUITINGAmicis Research Center
Valencia, California, United States
RECRUITINGNational Jewish Health
Denver, Colorado, United States
RECRUITINGSynergy Healthcare
Bradenton, Florida, United States
WITHDRAWNColumbus Clinical Services, LLC
Miami, Florida, United States
RECRUITINGPharmax Research of South Florida, Inc.
Miami, Florida, United States
RECRUITINGHealth Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
RECRUITINGPrimeway Clinical Research Group
Fayetteville, Georgia, United States
RECRUITINGPivotal Research Solutions
Stonecrest, Georgia, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITING...and 33 more locations
Time frame: 56 days
Incidence of injection site reactions
Time frame: 56 days