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Verekitug for adults with moderate-to-severe COPD

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)

Phase 2 Interventional Upstream Bio Inc. · NCT06981078

This trial will test whether verekitug (UPB-101), added to participants' usual inhaled COPD medicines, helps adults with moderate-to-severe COPD breathe better and have fewer flare-ups.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment666 (estimated)
Ages40 Years to 85 Years
SexAll
SponsorUpstream Bio Inc. Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations325 sites (Bakersfield, California and 324 other locations)
Trial IDNCT06981078 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 2 study testing two dose levels of verekitug versus placebo in adults with moderate-to-severe COPD who remain on their background inhaled therapies. Participants will be randomized 1:1:1 to receive one of two doses of verekitug or placebo and followed for treatment periods between about 60 and up to 108 weeks, plus a 16-week follow-up after the last dose. The study includes a screening period of approximately 4 weeks, long-term safety, tolerability, and efficacy assessments, and regular clinic visits for lung function and exacerbation monitoring. Sites listed are currently in California, but the protocol is designed as a multicenter global program.

Who should consider this trial

Good fit: Adults with physician-diagnosed COPD for more than 12 months, a smoking history of ≥10 pack-years, post-bronchodilator FEV1/FVC <0.70 and FEV1 between >30% and ≤80% predicted, mMRC grade ≥2, and who are on stable triple inhaled therapy are the intended participants.

Not a fit: Patients requiring more than 4 liters per minute of supplemental oxygen, those with recent COPD exacerbation or respiratory infection within 4 weeks, or those on systemic or biologic immunosuppressants are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, verekitug could reduce COPD exacerbations and improve lung function and symptoms when added to standard inhaled triple therapy.

How similar studies have performed: Biologic and anti-inflammatory approaches in COPD have produced mixed results previously, and this specific agent (verekitug) is a novel therapy that remains unproven in COPD until trial results are available.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bakersfield, California and 324 other locations

+275 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseVerekitugUPB-101EmphysemaChronic BronchitisThymic Stromal Lymphopoetin ReceptorLung InflammationBiologic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.