A Phase 2b Study to Assess the Efficacy and Safety of Verekitug in Participants with COPD
Research type
Research Study
Full title
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)
IRAS ID
1011324
Contact name
Justin Salciccioli
Contact email
Sponsor organisation
Upstream Bio Inc
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a lung condition characterised by inflammation of the bronchial tubes. This inflammation causes the airways to narrow and become clogged with mucus, making it difficult for patients to breathe. COPD is a chronic condition that significantly impacts patients' quality of life.
While there are existing treatments for COPD, there is still an unmet need for more effective therapies that can better manage the inflammation associated with the disease and improve patients' overall health outcomes.
This study aims to evaluate the effectiveness of an investigational drug called verekitug (also known as UPB-101) for treating moderate-to-severe COPD. Verekitug targets a protein that controls the immune system's response to inflammation, which is a key characteristic of COPD. The study will compare verekitug to a placebo to determine if it can improve COPD symptoms and related health effects.
Participants will be randomly assigned to receive an injection of either 100 mg verekitug every 12 weeks, 400 mg verekitug every 24 weeks, or a placebo every 12 weeks.
The study is "blinded," meaning neither participants nor researchers will know which treatment each participant is receiving.
Participants will need to visit the study center up to 19 times and receive up to 12 phone calls from study staff during their participation.The study will take place at approximately 350 centers globally, involving up to 666 participants with COPD. Participants will be involved in the study for 17 to 28 months, including a screening period, treatment period, and follow-up period.
The study is sponsored by Upstream Bio, Inc.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0107
Date of REC Opinion
23 Jul 2025
REC opinion
Further Information Favourable Opinion