Chronic Obstructive Pulmonary DiseasePhase 2NCT06981078
A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD
A Phase 2 study testing Verekitug in people with Chronic Obstructive Pulmonary Disease, run by Upstream Bio Inc. at 242 sites in 23 countries.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Verekitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 666 participants
- Where
- 242 sitesin 23 countries
- Study dates
- 2 Jul 2025to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
242 sites in 23 countries.
242 sites in 23 countries
United States29 sites
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Kern Research Inc.
Bakersfield, California, 93301
Christie Clinic, LLC
Champaign, Illinois, 61820
American Health Research, Inc.
Charlotte, North Carolina, 28277
SleepMed Inc.
Columbia, South Carolina, 29201
D&H Doral Research Center, LLC
Doral, Florida, 33122
El Paso Pulmonary Association
El Paso, Texas, 79902
PulmoCrit Associates
Encino, California, 91436
Velocity Clinical Research, Gaffney
Greenville, South Carolina, 29615
Qway Research, LLC
Hialeah, Florida, 33010
Victorium Clinical Research
Houston, Texas, 77024
Synergy Groups Medical LLC
Houston, Texas, 77036
Synergy Groups Medical LLC
Houston, Texas, 77061
Torrance Clinical Research Institute
Lomita, California, 90717-2101
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
Finlay Medical Research
Miami, Florida, 33126
MplusM - ITB Research
Miami, Florida, 33173
Synergy Groups Medical LLC
Missouri City, Texas, 77459
Florida Institute for Clinical Research,LLC
Orlando, Florida, 32825
Dream Team Clinical Research
Pomona, California, 91767
Velocity Clinical Research-Rockville
Rockville, Maryland, 20854
HealthPartners
Saint Paul, Minnesota, 55130
Apex Clinical Research
San Diego, California, 92120
Velocity Clinical Research-Savannah - Internal Medicine
Savannah, Georgia, 31406
Velocity Clinical Research, Spartanburg - Pulmonology
Spartanburg, South Carolina, 29303
Velocity Clinical Research - Suffolk
Suffolk, Virginia, 23435
Velocity Clinical Research- Union
Union, South Carolina, 29379
Allianz Research Institute
Westminster, California, 92683
Chesapeake Clinical Research, Inc
White Marsh, Maryland, 21162
Bulgaria22 sites
Specialized Hospital For Active Treatment Of Pulmonary Diseases Sv.Panteleymon EOOD
Dupnitsa, Pernik, 2307
Medical Center Pulmo-2018 EOOD
Haskovo, Haskovo, 6300
Medical Center - Zdrave1
Kozloduy, Vratsa, 3320
Medical Center Medconsult Pleven, Lovech branch
Lovech, Lovech, 5500
MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
Montana, Montana, 3400
Dr. Filip Shterev IAPSMCPP EOOD
Plovdiv, Plovdiv, 4000
Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
Plovdiv, Plovdiv, 4000
Multiprofile Hospital for Active Treatment "St. Panteleimon "- Plovdiv
Plovdiv, Plovdiv, 4004
Medical Center Prolet EOOD - Pulmonary, Allergy Diseases
Rousse, Ruse, 7002
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
Rousse, Ruse, 7002
Diagnostic consultative center 1 -Sliven
Sliven, Sliven, 8800
MHAT Sliven to MMA Sofia
Sliven, Sliven, 8800
Medical Center Excelsior OOD, Base 2
Sofia, Sofia, 1111
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, Sofia, 1407
First Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, 1142
Specialized Hospital For Active Treatment Of Pulmonary Diseases - Sofia EOOD
Sofia, Sofia-Grad, 1202
National Multiprofile Transport Hospital (NMTB) - Internal Diseases
Sofia, Sofia-Grad, 1233
Medical Center Excelsior OOD, Base 1
Sofia, Sofia-Grad, 1407
Medical Center Hera
Sofia, Sofia-Grad, 1510
DCC Convex EOOD
Sofia, Sofia-Grad, 1680
Medical Center for Outpatient Care Preventsia 2000
Stara Zagora, Stara Zagora, 6000
SHLTTRPD "Sveta Petka Balgarska" EOOD
Velingrad, Pazardzhik, 4600
United Kingdom21 sites
Royal Primary Care - Ashgate
Chesterfield, Derbyshire, S40 4AA
Lakeside Healthcare
Corby, Northamptonshire, NN17 2UR
NHS Tayside - Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Synexus Midlands Clinical Research Centre
Edgbaston, Birmingham, B15 2SQ
Panthera Biopartners - North London
Enfield, London, EN3 4GS
NHS Greater Glasgow & Clyde - Gartnavel General Hospital - Respiratory
Glasgow, Glasgow City, G12 0YN
Panthera Biopartners - Glasgow
Glasgow, Glasgow City, G51 4TY
Futuremeds - Glasgow
Glasgow, Scotland, G20 7BE
Velocity Clinical Research - High Wycombe
High Wycombe, Buckinghamshire, HP11 2QW
Leeds Teaching Hospitals NHS Trust - St James' University Hospital
Leeds, Leeds, LS9 7TF
FutureMeds Wirral
Metropolitan Borough of Wirral, Liverpool, CH62 6EE
Futuremeds -Teesside
Metropolitan Borough of Wirral, Wirral, TS19 8PE
Bioluminux Clinical Research
Milton Keynes, Bedfordshire, MK15 0DU
FutureMeds - Newcastle
Newcastle, United Kingdom, NE6 1SG
Ashburton Surgery
Newton Abbot, Devon, TQ13 7AP
Panthera Biopartners - Preston
Preston, Lancashire, PR2 9QB
Royal Berkshire Hospital
Reading, United Kingdom, RG1 5AN
Panthera Biopartners - Manchester
Rochdale, Manchester, OL11 4AU
Velocity Romford
Romford, Essex, RM1 3PJ
Panthera Biopartners - Sheffield
Sheffield, Sheffield, S2 5FX
Panthera Biopartners - York
York, York, YO24 4LJ
Germany20 sites
Gemeinschaftspraxis Rolke / Rückert
Aschaffenburg, Bavaria, 63739
Pneumologie, Schlafmedizin und Onkologie am Diako
Augsburg, Bavaria, 86150
CIMS Studienzentrum Bamberg
Bamberg, Bavaria, 96049
Studienpraxis Berlin-Brandenburg
Berlin, State of Berlin, 10119
Lungenpraxis Hohenzollerndamm
Berlin, State of Berlin, 10717
Velocity Clinical Research Germany GmBH
Berlin, State of Berlin, 10787
MECS Research GmbH
Berlin, State of Berlin, 12203
MECS GmbH
Cottbus, Brandenburg, 3050
Pneumostudien Darmstadt GmbH
Darmstadt, Hesse, 64283
IKF Pneumologie GmbH & Co. KG
Frankfurt am Main, Hesse, 60596
Pneumologicum-Halle - Pulmonary
Halle, Saxony-Anhalt, 6108
ME Clinical Respiratory Research
Hamburg, Free and Hanseatic City of Hamburg, 22299
Pneumologische Praxis und Schlaflabor - Lutz Volgmann
Hanover, Lower Saxony, 30167
Velocity Clinical Research Germany GmbH
Lübeck, Schleswig-Holstein, 23552
IKF Pneumologie GmbH & Co. KG
Mainz, Rhineland-Palatinate, 55128
Asklepios Lungenklinik Gauting GmbH - Zentrum für Pneumologie und Thoraxchirurgie
München, Bavaria, 82131
Ballenberger, Freytag, Wenisch
Neu-Isenburg, Hesse, 63263
Studienzentrum Dr.med. Christian Schlenska - Pneumologie/Allergologie/Innere Medizin
Peine, Lower Saxony, 31224
Framol-Med GmbH
Rheine, North Rhine-Westphalia, 48431
Gemeinschaftspraxis Franz, Weber
Witten, North Rhine-Westphalia, 58452
Poland15 sites
Centrum Medycyny Oddechowej, Mroz Spolka Jawna
Bialystok, Podlaskie Voivodeship, 15-044
ClinicMed Daniluk, Nowak Sp. Komandytowa
Bialystok, Podlaskie Voivodeship, 15-879
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Greater Poland Voivodeship, 85-796
Uniwersyteckie Centrum Kliniczne - Klinika Alergologii
Gdansk, Pomeranian Voivodeship, 80-214
Centrum Medyczne Pratia Katowice
Katowice, Warmian-Masurian Voivodeship, 40-081
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, 30-033
Pratia MCM Kraków
Krakow, Lesser Poland Voivodeship, 30-727
Clinical Best Solutions
Lublin, Lubusz Voivodeship, 20-078
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o. o.
Nowa Sól, Lubusz Voivodeship, 67-100
Specjalistyczna Przychodnia Lekarska Alergo - Med Sp. z o.o.
Poznan, Greater Poland Voivodeship, 61-578
Prywatny Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, 35-051
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, Podkarpackie Voivodeship, 35-205
Velocity Skierniewice Sp. z o.o.
Skierniewice, Lódzkie, 96-100
RCMed Oddzial Sochaczew
Sochaczew, Masovian Voivodeship, 96-500
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o. o.
Szczecin, West Pomeranian Voivodeship, 71-434
Spain15 sites
Vithas Xanit International Hospital - Gastroenterology
Benalmádena, Málaga, 29630
Hospital San Pedro de Alcántara
Cáceres, Extremadura, 10003
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital De Jerez De La Frontera
Jerez de la Frontera, Cádiz, 11407
Fundacion Jimenez Diaz
Madrid, Madrid, 28040
Hospital Universitario La Paz - Neumologia
Madrid, Madrid, 28046
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Hospital Quirónsalud Marbella
Marbella, Málaga, 29603
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 7120
Clinica Universidad de Navarra - Neumología
Pamplona, Navarre, 31008
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013
Hospital Sierrallana - Neumologia
Torrelavega, Cantabria, 39300
Hospital Clinico Universitario De Valencia - Neumologia
Valencia, Valencia, 46010
India12 sites
JNMC
Belgaum, West Bengal, 590010
S.P Medical College and Group of Hospitals, Bikaner
Bikaner, Rajasthan, 334001
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, 248001
Medanta Medicity
Gurgaon, Haryana, 122001
Astar Prime Hospitals - Internal Medicine
Hyderabad, Andhra Pradesh, 500036
Rajarshi Chhatrapati Shahu Maharaj (RCSM) Government Medical College & CPR Hospital
Kolhāpur, Maharashtra, 416002
NRS Medical College
Kolkata, West Bengal, 700014
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, 440009
A.C. Subba Reddy Government Medical College (ACSR) - Pulmonary
Nellore, Andhra Pradesh, 524004
Sir Ganga Ram Hospital (SGRH) - Gastroenterology and Hepatology
New Delhi, National Capital Territory of Delhi, 110 001
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) - Pandit Bhagwat Dayal Sharma
Rohtak, Haryana, 124001
Siddhartha Medical College
Vijayawada, Andhra Pradesh, 520008
Romania12 sites
Angisan Grup
Bragadiru, Ilfov, 77025
Centrul Medical de Diagnostic si Tratament Ambulator Neomed - Multiple Specialties
Brasov, Brașov County, 500283
Centrul Medical Sana
Bucharest, Bucharest, 11025
Medsana CM Cotroceni Pulmonology
Bucharest, Bucharest, 50521
Rimmed Centru Medical Pulmonology
Bucharest, Bucharest, 61334
Anima Specialty Medical Services
Bucharest, Bucharest, 616962
Fundatia Dr. Victor Babes
Bucuresti, Ilfov, 30303
CM Pneumologie Dr Mincu Bogdan
Cluj-Napoca, Cluj, 400275
Sp Pneumoftizio Leon Daniello CJ
Cluj-Napoca, Cluj, 400371
Clintrial Medical Center
Dobrosloveni, Olt, 237143
Sp.Clinic Pneumo Constanta Pulmon 2
Palazu Mare, Constanța County, 900002
Sp Dr Victor Babes Timisoara Pulmon
Timișoara, Timiș County, 300310
Ukraine12 sites
KNP "Cherkaska oblasna likarnia"
Cherkasy, Cherkasy Oblast, 18009
KNP"Ts inf.zakhv.Iv-Frank.obl.rady"
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Likuv.-diahn. tsentr Sviatoho Luky
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76019
MTs "Universalna klinika "Oberih"
Kyiv, Kyiv Oblast, 2000
DU "NNTs im. Yanovskoho"
Kyiv, Kyiv Oblast, 3038
Klin.likarnia na zal.transporti №2
Kyiv, Kyiv Oblast, 3049
DU "NNTs im. Yanovskoho"
Kyiv, Luhansk Oblast, 3038
MTs "Klinika Hospodarskykh"
Ternopil, Ternopil Oblast, 46002
Uzh.miska bahatoprofilna klin.lik.
Uzhhorod, Zakarpattia Oblast, 88009
Lik.z nevidkl. staniv ta ekstr.dop.
Uzhhorod, Zakarpattia Oblast, 88017
Medychnyi tsentr "Puls"
Vinnytsia, Vinnytsia Oblast, 21001
KNP "Likarnia №1" Zhytom.misk.rady
Zhytomyr, Zhytomyr Oblast, 10002
Hungary11 sites
Aranyklinika Kft
Bordány, Csongrád megye, 6720
ClinExpert Kft.
Budapest, Budapest, 1033
Pulmo Protect Kft.
Budapest, Budapest, 1044
Debreceni Egyetem Klinikai Központ - Tüdőgyógyászati Klinika
Debrecen, Debrecen, H-4012
Koch Róbert Kórház és Rendel?intézet
Edelény, Borsod-Abauj Zemplen county, H-3780
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582
Erzsebet Gondozohaz Kft.
Gödöllő, Pest County, 2100
Szalay Janos Rendelointezet
Hajdúnánás, Hajdú-Bihar, 4080
Kek Pont Aquagyogyaszat Kft.
Kecskemét, Bács-Kiskun county, 6000
Infer-Med Kft.
Pécs, Baranya, 7635
Puspokladanyi Egeszsegugyi Szolgaltato Nonprotfit Kft
Püspökladány, Heves County, 4150
Czechia10 sites
MUDr. I. Cierna Peterova s.r.o.
Brandýs nad Labem, Stredoceský Kraj, 25001
EDUMED, s.r.o
Broumov, Hradec Králové Region, 550 01
Plicni ambulance Kralupy s.r.o.
Kralupy nad Vltavou, Stredoceský Kraj, 278 01
MUDr. Pavlisova Ilona s.r.o.
Miroslav, South Moravian, 671 72
Plicni ambulance Alveolus s.r.o.
Poruba, Moravian-Silesian Region, 70800
MEDICON a.s. - Plicni oddeleni
Prague, Praha, Hlavní Mesto, 14000
Privatni plicni ambulance, s.r.o.
Prague, Praha, Hlavní Mesto, 19061
Plicni ambulance Rokycany
Rokycany, Rokycany, 33701
Plicni stredisko Teplice s.r.o. - Plicni ordinace
Teplice, Ústí nad Labem Region, 41501
Pneumologie Varnsdorf s.r.o.
Varnsdorf, Ústí nad Labem Region, 40747
Georgia9 sites
LTD "High Technology Hospital Medcenter"
Batumi, Adjara, 6010
LTD MARNECOR - Internal Medicine
Marneuli, Kvemo Kartli, 3000
LTD Clinic Rustavi
Rustavi, Hvemo Kartli, 3700
A. Aladashvili clinic LLC
Tbilisi, K'alak'i T'bilisi, 102
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, K'alak'i T'bilisi, 112
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, K'alak'i T'bilisi, 144
Center of Allergy and Immunology - Allergy/Immunology-Reumatology
Tbilisi, K'alak'i T'bilisi, 159
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
Tbilisi, K'alak'i T'bilisi, 159
Ltd Diacor
Tbilisi, K'alak'i T'bilisi, 159
Slovakia8 sites
FNsP F.D.R. Banska Bystrica - Pneumologie a ftizeologie
Banská Bystrica, Banská Bystrica Region, 97517
Pneumomed s.r.o. - Pneumo-Alergo Centrum
Bratislava, Bratislava Region, 85101
INSPIRO s.r.o. - MUDr. Golubov Alexander - Pneumologia a ftizeologia
Humenné, Presov, 066 01
PAFA, s.r.o.
Kežmarok, Presov, 6001
MEDEKA s.r.o. - Pneumologia a ftizeologia
Košice, Košice Region, 040 01
ZAPA JJ s.r.o. - Pneumologia a ftizeologia
Levice, Nitra Region, 934 01
DIONEA, s.r.o. - Ambul. pneumologie
Nové Zámky, Nitra Region, 940 01
Plucna ambulancia Hrebenar s.r.o.
Spišská Nová Ves, Košice Region, 052 01
South Korea8 sites
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, Incheon Gwang'Yeogsi [Inch'n-Kwangyokshi], 21431
Seoul National University Bundang Hospital - Pulmonology
Seongnam-si, Gyeonggido [Kyonggi-do], 13620
Korea University Anam Hospital - Pulmonology
Seoul, Seoul, 2841
Konkuk University Medical Center
Seoul, Seoul, 5030
Kyung Hee Universtiy Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 2447
Severance Hospital, Yonsei University Health System - Pulmonary
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 3722
Eunpyeong St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, 3312
Yonsei University, Wonju Severance Christian Hospital - Pulmonology
Wŏnju, Gang'Weondo [Kang-won-do], 26426
Taiwan8 sites
National Taiwan University Hospital - Yunlin Branch - Douliou
Douliu, Yunlin, 640203
KMU Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 80756
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City, Kaohsiung, 833401
Taichung Veterans General Hospital - Chest Medicine
Taichung, Taichung, 407219
Kuang Tien General Hospital - XiangShang
Taichung, Taichung, 433
Chi Mei Medical Center - YongKang - Pulmonary Medicine
Tainan, Tainan, 71004
Taipei Medical University - Taipei Medical University Hospital - Internal Medicine
Taipei, Taipei, 110
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Pulmonary
Taoyuan, Taoyuan, 333423
Argentina6 sites
CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, Buenos Aires, C1414AIF
Consultorios Médicos Dr. Doreski
Buenos Aires, Buenos Aires, C1426ABP
Centro de Medicina Respiratoria
Concepción del Uruguay, Entre Ríos Province, 3260
Fundacion Scherbovsky
Mendoza, Mendoza Province, 5500
Fundacion Estudios Clinicos (FECLIN)
Rosario, Santa Fe Province, 2000
Instituto Médico Fundación Grupo Colaborativo Rosario Invest
Rosario, Santa Fe Province, 2000
Philippines6 sites
De Asis Medical Clinic (Norzel Medical and Diagnostic Clinic)
Cebu, Cebu, 6000
Perpetual succour hospital of Cebu INC
Cebu, Cebu, 6000
CARE Clinical Trial Group Inc.
Dasmariñas, Cavite, 4114
Iloilo Doctors' Hospital Inc.
Iloilo City, Iloilo, 5000
Health Cube Medical Clinics
Mandaluyong, National Capital Region, 1552
Marilao Saint Michael Family Hospital, Inc. - Research Room
Marilao, Bulacan, 3019
Malaysia5 sites
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990
Institut Perubatan Respiratori
Kuala Lumpur, Kuala Lumpur, 53000
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Thomson Hospital Kota Damansara
Petaling Jaya, Selangor, 47500
Universiti Teknologi MARA
Shah Alam, Selangor, 68100
Latvia4 sites
Veselibas Centru apvieniba AS, Dubultu poliklinika
Jūrmala, Jūrmala, LV-2010
Liepaja Regional Hospital
Liepāja, Liepaja, LV-3414
Pauls Stradins Clinical University Hospital - Center of Lung Diseases
Riga, Riga, LV-1002
SIA "Profesora Skrides Sirds klīnika"
Riga, Riga, LV-1013
Ireland3 sites
Our Lady of Lourdes Hospital
Drogheda, Louth, A92VW28
Connolly Hospital
Dublin, Dublin, D15 X40D
Tallaght University Hospital
Tallaght, Dublin, D24 NR0A
Lithuania3 sites
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Kaunas County, LT 50161
Lithuanian University of Health Sciences Kaunas Hospital
Kaunas, Kaunas County, LT-47116
Republic Klaipeda Hospital
Klaipėda, Klaipėda County, LT-92231
Chile2 sites
Centro de Investigación de Enfermedades Respiratorias e Inmunológicas
Viña del Mar, Valparaiso, 2520000
Clinica Fundacion Medica San Cristobal
Vitacura, Santiago Metropolitan, 7630226
Serbia1 site
Institute for Pulmonary Diseases of Vojvodina, Clinic for Pulmonary Oncology
Kamenitz, Vojvodina, 21204
About this study
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)
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Verekitug, Placebo
- Keywords
- Verekitug, UPB-101, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis, Thymic Stromal Lymphopoetin Receptor, Lung Inflammation, Biologic, Monoclonal Antibody, VENTURE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerekitugDrug
Also called UPB-101
Verekitug (UPB-101) formulated solution
PlaceboOther
Matching Placebo to Verekitug (UPB-101)
| Study group | Role | What they receive |
|---|---|---|
| Verekitug (UPB-101) 100 mg and Placebo | Experimental | 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. Receives: Drug: Verekitug; Other: Placebo |
| Verekitug (UPB-101) 400 mg and Placebo | Experimental | 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. Receives: Drug: Verekitug; Other: Placebo |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of moderate or severe COPD exacerbation events
Measured: From Day 1 (Baseline) up to Week 108
Secondary outcomes (5)
Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)
Measured: From Day 1 (Baseline) to Week 60
Annualized rate of severe COPD exacerbation events
Measured: From Day 1 (Baseline) up to Week 108
Change in St. George's Respiratory Questionnaire (SGRQ) total score
Measured: From Day 1 (Baseline) to Week 60
Proportion of participants with SGRQ improvement of >4 points
Measured: At Week 60
Incidence of treatment-emergent adverse events and serious adverse events
Measured: From Day 1 (Baseline) up to Week 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start2 Jul 2025
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Upstream Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin Salciccioli, MD, Study director, Upstream Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981078
- Sponsor's protocol ID
- UPB-CP-06
- Other IDs
- 2025-520488-42-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 9 May 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06981078
- Acronym / sponsor ID
- UPB-CP-06
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Verekitug, UPB-101, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis, Thymic Stromal Lymphopoetin Receptor, Lung Inflammation, Biologic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 666 participants (estimated)
- Lead sponsor
- Upstream Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verekitug (UPB-101) 100 mg and Placebo | Experimental | Drug: Verekitug, Other: PlaceboParticipants 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. |
| Verekitug (UPB-101) 400 mg and Placebo | Experimental | Drug: Verekitug, Other: PlaceboParticipants 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerekitugAlso: UPB-101Verekitug (UPB-101) formulated solution | Drug | Verekitug (UPB-101) 100 mg and Placebo, Verekitug (UPB-101) 400 mg and Placebo |
| PlaceboMatching Placebo to Verekitug (UPB-101) | Other | Placebo, Verekitug (UPB-101) 100 mg and Placebo, Verekitug (UPB-101) 400 mg and Placebo |
Primary outcome
Annualized rate of moderate or severe COPD exacerbation events
Time frame: From Day 1 (Baseline) up to Week 108
5 secondary outcomes
Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)
Time frame: From Day 1 (Baseline) to Week 60
Annualized rate of severe COPD exacerbation events
Time frame: From Day 1 (Baseline) up to Week 108
Change in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: From Day 1 (Baseline) to Week 60
Proportion of participants with SGRQ improvement of >4 points
Time frame: At Week 60
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: From Day 1 (Baseline) up to Week 112
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Salciccioli, MD study director
Upstream Bio
242 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verekitug in people with Chronic Obstructive Pulmonary Disease, run by Upstream Bio Inc. at 242 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 242 sites in United States, Bulgaria, United Kingdom, Germany, Poland and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of moderate or severe COPD exacerbation events (time frame: From Day 1 (Baseline) up to Week 108). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.