> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-efficacy-and-safety-of-verekitug-in-7ffd36d3-3b1d-4dc6-a3a1-220323379667 > Record changed: 2026-10-29 # A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD NCT06981078 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) Participants 666 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) Lead sponsor Upstream Bio Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) Start date 2025-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) Number of sites 242 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Short title** A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Dates **Completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **First posted** 2025-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Primary completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Start date** 2025-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Size and sites **Participants** 666 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Planned participants** 666 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Number of sites** 242 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Lead sponsor** Upstream Bio Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Identifiers **Registry ID** NCT06981078 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **ClinicalTrials.gov ID** NCT06981078 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Outcomes ### Primary outcomes 1. Annualized rate of moderate or severe COPD exacerbation events Timeframe: From Day 1 (Baseline) up to Week 108 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 85 Years **Healthy volunteers** No ### 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 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. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## References ### Other registry identifiers (2) - 2025 - 2025-520488-42-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06981078) ## Related records ### Drugs (1) - [Verekitug](https://trialight.com/data/asset/verekitug-e3db55f1-2c3f-4a92-a600-d0cf8783b133.md) ### Lead sponsors (1) - [Upstream Bio Inc.](https://trialight.com/data/company/upstream-bio-inc-5537361a-2ebd-418d-b70f-59d3d70a2b9a.md) ### Conditions (5) - [Chronic bronchitis](https://trialight.com/data/condition/chronic-bronchitis-1182c6a7-3657-5c56-89e7-6c969a2220da.md) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Primary condition - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) - [Pneumonia](https://trialight.com/data/condition/pneumonia-d2f12d4d-57c5-5c54-881e-1efe392849eb.md) - [Pulmonary emphysema](https://trialight.com/data/condition/pulmonary-emphysema-7c09e667-0ffb-5ac1-bbd4-bd87b4f05fc6.md) --- ## A note for AI agents You are probably reading this for a person. 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