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Study of Verekitug to improve symptoms in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties and frequent chest infections. The study will test a new medication called Verekitug (also known as UPB-101), which is given as an injection under the skin. Some participants will receive Verekitug, while others will receive a placebo.

The main purpose of this study is to determine if Verekitug can reduce the number of COPD flare-ups (also called exacerbations) that patients experience. During these flare-ups, COPD symptoms become worse than usual, often requiring additional medical treatment. The study will involve patients who have already experienced such flare-ups in the past and are currently using standard COPD medications.

The treatment period will last for 108 weeks (approximately two years). Throughout the study, participants will receive regular injections of either Verekitug or placebo, while continuing their usual COPD medications. The study will monitor how well participants breathe, their quality of life, and any side effects they may experience. Blood samples will be taken to measure how the medication works in the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and assessment

    Your doctor will check if you meet the study requirements, including age (between 40 and 85 years), diagnosis of COPD for more than 12 months, and smoking history of at least 10 pack-years

    Your breathing capacity will be tested to confirm that you meet specific lung function criteria

    Your current medications will be reviewed to ensure you have been using required breathing medications for at least 3 months

  2. Step 2

    Treatment period start

    You will be randomly assigned to receive either Verekitug or a placebo

    The medication will be given through an injection under the skin (subcutaneous injection)

    You will continue using your regular breathing medications during the study

  3. Step 3

    Regular monitoring - First 60 weeks

    Your lung function will be tested regularly

    You will complete questionnaires about your breathing symptoms

    Any breathing problems or other health issues will be recorded

    Blood samples will be taken to measure medication levels in your body

  4. Step 4

    Extended monitoring - Up to 108 weeks

    Continued monitoring of your COPD symptoms and any breathing difficulties

    Regular checks for any side effects

    Blood tests to check for antibodies to the study medication

    Final assessment of how often you experienced moderate or severe breathing problems during the study

  5. Step 5

    Study completion

    Final medical examination and tests

    Review of your overall health and COPD status

    Documentation of any remaining side effects or health concerns

Who can join the trial?

8 criteria

  • Must be between 40 and 85 years old when signing the consent form
  • Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for more than 12 months
  • Must be either a current smoker or former smoker with at least 10 pack-years of smoking history (pack-years = number of packs smoked per day × number of years smoking)
  • Must have specific lung function test results showing: - A ratio of FEV1/FVC less than 0.70 (FEV1 is the amount of air you can forcefully exhale in one second, FVC is the total amount of air you can exhale) - Lung function between 30% and 80% of normal predicted values
  • Must have significant breathlessness rated as grade 2 or higher on the Modified Medical Research Council scale
  • Must have experienced either: - More than 2 moderate flare-ups or - At least 1 severe flare-up of COPD in the past year
  • Must be taking triple therapy (three different types of inhaled medications: steroids, long-acting beta-agonists, and long-acting muscarinic antagonists) for at least 3 months, with a stable dose for at least 1 month before the first visit. If steroid inhalers cannot be used, taking two types of medications is acceptable
  • Must show at least 80% compliance with current medication for at least 4 consecutive weeks during the screening period

Who cannot join the trial?

14 criteria

  • History of asthma or other significant lung diseases besides COPD (chronic obstructive pulmonary disease)
  • Current lung infection or active respiratory illness
  • Major surgery within the past 3 months
  • Severe heart problems or uncontrolled cardiovascular disease
  • Current or recent cancer treatment within the past 5 years (except for certain skin cancers)
  • Participation in another clinical trial within the past 30 days
  • Allergies to medications similar to the study drug
  • History of severe allergic reactions to any medications
  • Significant kidney or liver problems
  • Pregnant women or women planning to become pregnant
  • Current drug or alcohol abuse
  • Unable to perform required study procedures or follow study instructions
  • Any condition that the study doctor believes would make participation unsafe
  • Taking medications that could interact with the study drug
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Investigated drugs

Verekitug (also known as UPB-101) is an investigational medication being studied for treating moderate to severe Chronic Obstructive Pulmonary Disease (COPD). This medication is being tested to see if it can help reduce COPD exacerbations, which are periods when COPD symptoms become worse than usual. It's a new treatment option being evaluated to help patients who experience breathing difficulties and other COPD symptoms.

What is already known about the treatment

Verekitug – A novel investigational drug (UPB-101) currently undergoing Phase 2b clinical trials for the treatment of moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). This medication is being studied primarily for its potential to reduce COPD exacerbations, which are sudden worsening of respiratory symptoms. While the specific form of administration is not detailed in the provided data, as a COPD medication, it is likely administered through inhalation. The drug is currently being evaluated in a randomized, double-blind, placebo-controlled study to assess both its efficacy and safety profile in COPD patients.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) – A progressive respiratory condition that makes breathing increasingly difficult over time. The disease causes the airways to become inflamed and narrowed, while also damaging the tiny air sacs (alveoli) in the lungs. The main characteristic of COPD is reduced airflow in and out of the lungs, which causes shortness of breath and other respiratory symptoms. The condition typically develops slowly over many years, with symptoms gradually becoming more noticeable and affecting daily activities. Patients may experience periods of symptom worsening called exacerbations, which can vary in severity from moderate to severe.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520488-42-00Protocol codeUPB-CP-06Estimated enrolment666 patientsSponsorUpstream Bio Inc.

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