NCT06981078

A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 666 (estimated)
• Sponsor: Upstream Bio Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Verekitug	Verekitug (UPB-101) formulated solution
OTHER	Placebo	Matching Placebo to Verekitug (UPB-101)

Timeline

• Start date: 2025-07-02
• Primary completion: 2028-04-01
• Completion: 2028-07-01
• First posted: 2025-05-20
• Last updated: 2026-02-13

Locations

325 sites across 28 countries: United States, Argentina, Bulgaria, Chile, Czechia, Georgia, Germany, Hungary, India, Ireland, Latvia, Lithuania, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study