A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Upstream Bio Inc.
Summary
The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.
Description
This is a global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD. Adult participants are planned to be enrolled and will be allocated randomly in a 1:1:1 ratio to one of two dose levels of verekitug or placebo, in addition to their COPD background medications. The study consists of a screening period of approximately 4 weeks; treatment periods of between 60 weeks and up to 108 weeks; and a follow-up period, with the end-of-study visit 16 weeks after last dose.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Physician diagnosis of COPD for \>12 months. * Current or former smokers with a smoking history of 10 pack-years or more. * Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio \<0.70 and predicted post-bronchodilator FEV1 \>30% and ≤80%. * Modified Medical Research Council dyspnea scale Grade ≥2. * Background triple therapy (Inhaled Corticosteroid \[ICS\], Long-Acting Beta Agonist \[LABA\], Long-Acting Muscarinic Antagonist \[LAMA\]) for 3 months before randomization with a stable dose of medications for 1 or more months prior to Visit 1. * Are ≥80% compliant wit…
Interventions
- DrugVerekitug
Verekitug (UPB-101) formulated solution
- OtherPlacebo
Matching Placebo to Verekitug (UPB-101)
Locations (325)
- Kern Research Inc.Bakersfield, California
- PulmoCrit AssociatesEncino, California
- Torrance Clinical Research InstituteLomita, California
- Dream Team Clinical ResearchPomona, California
- Apex Clinical ResearchSan Diego, California
- Allianz Research InstituteWestminster, California