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

Last updated: July 31, 2025
Sponsor: Upstream Bio Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Verekitug

Clinical Study ID

NCT06981078
UPB-CP-06
2025-520488-42-00
  • Ages 40-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 predictedpost-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 randomizationwith a stable dose of medications for 1 or more months prior to Visit 1.

  • Are ≥80% compliant with background therapy during the screening period.

Exclusion

Exclusion Criteria:

  • Moderate or severe exacerbation of COPD within 4 weeks prior to or during thescreening period.

  • Respiratory tract infection within 4 weeks prior to or during the screening period.

  • Treatment with oxygen of >4 liters/minute. Nocturnal oxygen use for sleep apnea isallowed.

  • Systemic or biologic immunosuppressant therapy to treat inflammatory disease orautoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever islonger, with the exception of oral corticosteroids. Treatment with cyclophosphamideand rituximab within 12 months of Visit 1.

  • Current diagnosis of asthma according to the 2023 Global Initiative for Asthmaguidelines or other accepted guidelines

  • History or evidence of a clinically meaningful pulmonary condition other than COPD (e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonaryhypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonaryor systemic disease associated with elevated peripheral eosinophil counts.

  • Chronic hypercapnia requiring Bilevel Positive Airway Pressure (BiPAP). Participantsrequiring BiPAP periodically for an acute COPD exacerbation are not excluded.

  • Any of the following in the previous 6 months prior to Visit 1: acute myocardialinfarction, transient ischemic attack or stroke, hospitalization for anycardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosisand cardiac arrhythmias including paroxysmal (e.g., intermittent). Participants withpersistent atrial fibrillation as defined by continuous atrial fibrillation for atleast 6 months and controlled with a rate control strategy (i.e., selective betablocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy)and stable appropriate level of anticoagulation for at least 6 months may beconsidered for inclusion.

Study Design

Total Participants: 666
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 02, 2025
Estimated Completion Date:
August 31, 2029

Study 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.

Connect with a study center

  • D&H Doral Research Center, LLC

    Doral, Florida 33122
    United States

    Active - Recruiting

  • Qway Research, LLC

    Hialeah, Florida 33010
    United States

    Active - Recruiting

  • Research Institute of South Florida

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Velocity Clinical Research, Gaffney

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Velocity Clinical Research, Spartanburg - Pulmonology

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Velocity Clinical Research- Union

    Union, South Carolina 29379
    United States

    Site Not Available

  • Elligo Health Research, Inc.

    Austin, Texas 78738
    United States

    Site Not Available

  • El Paso Pulmonary Association

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas 75069
    United States

    Active - Recruiting

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