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

NCT06981078
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
666
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Lead sponsor
Upstream Bio Inc.
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Start date
2025-07-02
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Number of sites
242
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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.
clinicaltrials.gov
Short title
A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD
clinicaltrials.gov
Official 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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-11-01
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First posted
2025-05-20
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Registry last updated
2026-07-20
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Primary completion date
2027-10-01
clinicaltrials.gov
Start date
2025-07-02
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Participants
666
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Participant count basis
Estimated
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Planned participants
666
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Protocol amendments
0
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Randomisation ratio
1:1:1
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Number of sites
242
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Upstream Bio Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06981078
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06981078
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Annualized rate of moderate or severe COPD exacerbation events

    Timeframe: From Day 1 (Baseline) up to Week 108

  1. Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)

    Timeframe: From Day 1 (Baseline) to Week 60

  2. Annualized rate of severe COPD exacerbation events

    Timeframe: From Day 1 (Baseline) up to Week 108

  3. Change in St. George's Respiratory Questionnaire (SGRQ) total score

    Timeframe: From Day 1 (Baseline) to Week 60

  4. Proportion of participants with SGRQ improvement of >4 points

    Timeframe: At Week 60

  5. Incidence of treatment-emergent adverse events and serious adverse events

    Timeframe: From Day 1 (Baseline) up to Week 112

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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 with background therapy during the screening period.

  • Moderate or severe exacerbation of COPD within 4 weeks prior to or during the screening 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 is allowed.
  • Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1.
  • Current diagnosis of asthma according to the 2023 Global Initiative for Asthma guidelines or other accepted guidelines
  • History or evidence of a clinically meaningful pulmonary condition other than COPD (e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Chronic hypercapnia requiring Bilevel Positive Airway Pressure (BiPAP). Participants requiring BiPAP periodically for an acute COPD exacerbation are not excluded.
  • Any of the following in the previous 6 months prior to Visit 1: acute myocardial infarction, transient ischemic attack or stroke, hospitalization for any cardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosis and cardiac arrhythmias including paroxysmal (e.g., intermittent). Participants with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) and stable appropriate level of anticoagulation for at least 6 months may be considered for inclusion.
Sources for eligibility
clinicaltrials.gov

  • Kern Research Inc.Bakersfield, United States
  • PulmoCrit AssociatesEncino, United States
  • Torrance Clinical Research InstituteLomita, United States
  • Dream Team Clinical ResearchPomona, United States
  • Apex Clinical ResearchSan Diego, United States
  • Allianz Research InstituteWestminster, United States
  • D&H Doral Research Center, LLCDoral, United States
  • Qway Research, LLCHialeah, United States
  • Finlay Medical ResearchMiami, United States
  • MplusM - ITB ResearchMiami, United States
  • Florida Institute for Clinical Research,LLCOrlando, United States
  • Velocity Clinical Research-Savannah - Internal MedicineSavannah, United States
  • Christie Clinic, LLCChampaign, United States
  • Velocity Clinical Research-RockvilleRockville, United States
  • Chesapeake Clinical Research, IncWhite Marsh, United States
  • HealthPartnersSaint Paul, United States
  • American Health Research, Inc.Charlotte, United States
  • Velocity Clinical Research, AndersonAnderson, United States
  • SleepMed Inc.Columbia, United States
  • Velocity Clinical Research, GaffneyGreenville, United States
  • Velocity Clinical Research, Spartanburg - PulmonologySpartanburg, United States
  • Velocity Clinical Research- UnionUnion, United States
  • El Paso Pulmonary AssociationEl Paso, United States
  • Victorium Clinical ResearchHouston, United States
  • Synergy Groups Medical LLCHouston, United States

And 217 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-520488-42-00
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

Conditions (5)