ClinicalTrials.gg
Active, not recruitingNCT06981078Updated Jul 20, 2026

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

A Phase 2 interventional study of Verekitug and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Upstream Bio Inc.. Active, not recruiting at 242 sites in 23 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Upstream Bio Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
666
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Verekitug
  • UPB-101
  • Chronic Obstructive Pulmonary Disease
  • Emphysema
  • Chronic Bronchitis
  • Thymic Stromal Lymphopoetin Receptor
  • Lung Inflammation
  • Biologic
  • Monoclonal Antibody
  • VENTURE
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 666 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Upstream Bio Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Physician diagnosis of for >12 months.
  • Current or former smokers with a smoking history of 10 pack-years or more.
  • Post-bronchodilator / 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 [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

Exclusion Criteria:

  • Moderate or severe exacerbation of 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 therapy to treat inflammatory disease or disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral . 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 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, 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
666 participants (estimated)

Study arms

  • Experimental
    Verekitug (UPB-101) 100 mg and Placebo

    Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.

    Drug: Verekitug · Other: Placebo

  • Experimental
    Verekitug (UPB-101) 400 mg and Placebo

    Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits.

    Drug: Verekitug · Other: Placebo

  • Placebo comparator
    Placebo

    Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.

    Other: Placebo

Interventions

  • Verekitug (UPB-101) formulated solution

    Also known as: UPB-101

  • OtherPlacebo

    Matching Placebo to Verekitug (UPB-101)

06

What researchers measure

Primary outcomes

  1. Annualized rate of moderate or severe COPD exacerbation events

    Time frame: From Day 1 (Baseline) up to Week 108

Secondary outcomes

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

    Time frame: From Day 1 (Baseline) to Week 60

  2. Annualized rate of severe COPD exacerbation events

    Time frame: From Day 1 (Baseline) up to Week 108

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

    Time frame: From Day 1 (Baseline) to Week 60

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

    Time frame: At Week 60

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

    Time frame: From Day 1 (Baseline) up to Week 112

07

Study locations

242 sites
  • Kern Research Inc.
    Bakersfield, California 93301, United States
  • PulmoCrit Associates
    Encino, California 91436, United States
  • Torrance Clinical Research Institute
    Lomita, California 90717-2101, United States
  • Dream Team Clinical Research
    Pomona, California 91767, United States
  • Apex Clinical Research
    San Diego, California 92120, United States
  • Allianz Research Institute
    Westminster, California 92683, United States
  • D&H Doral Research Center, LLC
    Doral, Florida 33122, United States
  • Qway Research, LLC
    Hialeah, Florida 33010, United States
  • Finlay Medical Research
    Miami, Florida 33126, United States
  • MplusM - ITB Research
    Miami, Florida 33173, United States
  • Florida Institute for Clinical Research,LLC
    Orlando, Florida 32825, United States
  • Velocity Clinical Research-Savannah - Internal Medicine
    Savannah, Georgia 31406, United States
  • Christie Clinic, LLC
    Champaign, Illinois 61820, United States
  • Velocity Clinical Research-Rockville
    Rockville, Maryland 20854, United States
  • Chesapeake Clinical Research, Inc
    White Marsh, Maryland 21162, United States
  • HealthPartners
    Saint Paul, Minnesota 55130, United States
  • American Health Research, Inc.
    Charlotte, North Carolina 28277, United States
  • Velocity Clinical Research, Anderson
    Anderson, South Carolina 29621, United States
  • SleepMed Inc.
    Columbia, South Carolina 29201, United States
  • Velocity Clinical Research, Gaffney
    Greenville, South Carolina 29615, United States
  • Velocity Clinical Research, Spartanburg - Pulmonology
    Spartanburg, South Carolina 29303, United States
  • Velocity Clinical Research- Union
    Union, South Carolina 29379, United States
  • El Paso Pulmonary Association
    El Paso, Texas 79902, United States
  • Victorium Clinical Research
    Houston, Texas 77024, United States
  • Synergy Groups Medical LLC
    Houston, Texas 77036, United States
  • Synergy Groups Medical LLC
    Houston, Texas 77061, United States
  • Metroplex Pulmonary and Sleep Center
    McKinney, Texas 75069, United States
  • Synergy Groups Medical LLC
    Missouri City, Texas 77459, United States
  • Velocity Clinical Research - Suffolk
    Suffolk, Virginia 23435, United States
  • CARE - Centro de Alergia y Enfermedades Respiratorias
    Buenos Aires, Buenos Aires C1414AIF, Argentina
  • Consultorios Médicos Dr. Doreski
    Buenos Aires, Buenos Aires C1426ABP, Argentina
  • Centro de Medicina Respiratoria
    Concepción del Uruguay, Entre Ríos Province 3260, Argentina
  • Fundacion Scherbovsky
    Mendoza, Mendoza Province 5500, Argentina
  • Fundacion Estudios Clinicos (FECLIN)
    Rosario, Santa Fe Province 2000, Argentina
  • Instituto Médico Fundación Grupo Colaborativo Rosario Invest
    Rosario, Santa Fe Province 2000, Argentina
  • Medical Center Pulmo-2018 EOOD
    Haskovo, Haskovo 6300, Bulgaria
  • Medical Center Medconsult Pleven, Lovech branch
    Lovech, Lovech 5500, Bulgaria
  • MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
    Montana, Montana 3400, Bulgaria
  • SHLTTRPD "Sveta Petka Balgarska" EOOD
    Velingrad, Pazardzhik 4600, Bulgaria
  • Specialized Hospital For Active Treatment Of Pulmonary Diseases Sv.Panteleymon EOOD
    Dupnitsa, Pernik 2307, Bulgaria
  • Dr. Filip Shterev IAPSMCPP EOOD
    Plovdiv, Plovdiv 4000, Bulgaria
  • Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
    Plovdiv, Plovdiv 4000, Bulgaria
  • Multiprofile Hospital for Active Treatment "St. Panteleimon "- Plovdiv
    Plovdiv, Plovdiv 4004, Bulgaria
  • Medical Center Prolet EOOD - Pulmonary, Allergy Diseases
    Rousse, Ruse 7002, Bulgaria
  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
    Rousse, Ruse 7002, Bulgaria
  • Diagnostic consultative center 1 -Sliven
    Sliven, Sliven 8800, Bulgaria
  • MHAT Sliven to MMA Sofia
    Sliven, Sliven 8800, Bulgaria
  • Medical Center Excelsior OOD, Base 2
    Sofia, Sofia 1111, Bulgaria
  • Acibadem City Clinic Tokuda University Hospital EAD
    Sofia, Sofia 1407, Bulgaria
  • First Multiprofile Hospital for Active Treatment - Sofia
    Sofia, Sofia-Grad 1142, Bulgaria
  • Specialized Hospital For Active Treatment Of Pulmonary Diseases - Sofia EOOD
    Sofia, Sofia-Grad 1202, Bulgaria
  • National Multiprofile Transport Hospital (NMTB) - Internal Diseases
    Sofia, Sofia-Grad 1233, Bulgaria
  • Medical Center Excelsior OOD, Base 1
    Sofia, Sofia-Grad 1407, Bulgaria
  • Medical Center Hera
    Sofia, Sofia-Grad 1510, Bulgaria
  • DCC Convex EOOD
    Sofia, Sofia-Grad 1680, Bulgaria
  • Medical Center for Outpatient Care Preventsia 2000
    Stara Zagora, Stara Zagora 6000, Bulgaria
  • Medical Center - Zdrave1
    Kozloduy, Vratsa 3320, Bulgaria
  • Clinica Fundacion Medica San Cristobal
    Vitacura, Santiago Metropolitan 7630226, Chile
  • Centro de Investigación de Enfermedades Respiratorias e Inmunológicas
    Viña del Mar, Valparaiso 2520000, Chile
  • EDUMED, s.r.o
    Broumov, Hradec Králové Region 550 01, Czechia
  • Plicni ambulance Alveolus s.r.o.
    Poruba, Moravian-Silesian Region 70800, Czechia
  • MEDICON a.s. - Plicni oddeleni
    Prague, Praha, Hlavní Mesto 14000, Czechia
  • Privatni plicni ambulance, s.r.o.
    Prague, Praha, Hlavní Mesto 19061, Czechia
  • Plicni ambulance Rokycany
    Rokycany, Rokycany 33701, Czechia
  • MUDr. Pavlisova Ilona s.r.o.
    Miroslav, South Moravian 671 72, Czechia
  • MUDr. I. Cierna Peterova s.r.o.
    Brandýs nad Labem, Stredoceský Kraj 25001, Czechia
  • Plicni ambulance Kralupy s.r.o.
    Kralupy nad Vltavou, Stredoceský Kraj 278 01, Czechia
  • Plicni stredisko Teplice s.r.o. - Plicni ordinace
    Teplice, Ústí nad Labem Region 41501, Czechia
  • Pneumologie Varnsdorf s.r.o.
    Varnsdorf, Ústí nad Labem Region 40747, Czechia
  • LTD "High Technology Hospital Medcenter"
    Batumi, Adjara 6010, Georgia
  • LTD Clinic Rustavi
    Rustavi, Hvemo Kartli 3700, Georgia
  • A. Aladashvili clinic LLC
    Tbilisi, K'alak'i T'bilisi 102, Georgia
  • LTD "Israel-Georgian Medical Research Clinic Healthycore"
    Tbilisi, K'alak'i T'bilisi 112, Georgia
  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
    Tbilisi, K'alak'i T'bilisi 144, Georgia
  • Center of Allergy and Immunology - Allergy/Immunology-Reumatology
    Tbilisi, K'alak'i T'bilisi 159, Georgia
  • LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
    Tbilisi, K'alak'i T'bilisi 159, Georgia
  • Ltd Diacor
    Tbilisi, K'alak'i T'bilisi 159, Georgia
  • LTD MARNECOR - Internal Medicine
    Marneuli, Kvemo Kartli 3000, Georgia
  • Gemeinschaftspraxis Rolke / Rückert
    Aschaffenburg, Bavaria 63739, Germany
  • Pneumologie, Schlafmedizin und Onkologie am Diako
    Augsburg, Bavaria 86150, Germany
  • CIMS Studienzentrum Bamberg
    Bamberg, Bavaria 96049, Germany
  • Asklepios Lungenklinik Gauting GmbH - Zentrum für Pneumologie und Thoraxchirurgie
    München, Bavaria 82131, Germany
  • MECS GmbH
    Cottbus, Brandenburg 3050, Germany
  • ME Clinical Respiratory Research
    Hamburg, Free and Hanseatic City of Hamburg 22299, Germany
  • Pneumostudien Darmstadt GmbH
    Darmstadt, Hesse 64283, Germany
  • IKF Pneumologie GmbH & Co. KG
    Frankfurt am Main, Hesse 60596, Germany
  • Ballenberger, Freytag, Wenisch
    Neu-Isenburg, Hesse 63263, Germany
  • Pneumologische Praxis und Schlaflabor - Lutz Volgmann
    Hanover, Lower Saxony 30167, Germany
  • Studienzentrum Dr.med. Christian Schlenska - Pneumologie/Allergologie/Innere Medizin
    Peine, Lower Saxony 31224, Germany
  • Framol-Med GmbH
    Rheine, North Rhine-Westphalia 48431, Germany
  • Gemeinschaftspraxis Franz, Weber
    Witten, North Rhine-Westphalia 58452, Germany
  • IKF Pneumologie GmbH & Co. KG
    Mainz, Rhineland-Palatinate 55128, Germany
  • Pneumologicum-Halle - Pulmonary
    Halle, Saxony-Anhalt 6108, Germany
  • Velocity Clinical Research Germany GmbH
    Lübeck, Schleswig-Holstein 23552, Germany
  • Studienpraxis Berlin-Brandenburg
    Berlin, State of Berlin 10119, Germany
  • Lungenpraxis Hohenzollerndamm
    Berlin, State of Berlin 10717, Germany
  • Velocity Clinical Research Germany GmBH
    Berlin, State of Berlin 10787, Germany
  • MECS Research GmbH
    Berlin, State of Berlin 12203, Germany
  • Infer-Med Kft.
    Pécs, Baranya 7635, Hungary
  • Koch Róbert Kórház és Rendel?intézet
    Edelény, Borsod-Abauj Zemplen county H-3780, Hungary

Showing the first 100 of 242 sites across 23 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06981078
Lead sponsor
Upstream Bio Inc.
Responsible party
Sponsor
First posted
May 20, 2025
Start date
Jul 2, 2025
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Jul 20, 2026

Study contacts

Justin Salciccioli, MD
study director · Upstream Bio

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Verekitug

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