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

July 17, 2026 updated by: Upstream Bio Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

666

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1414AIF
        • CARE - Centro de Alergia y Enfermedades Respiratorias
      • Buenos Aires, Buenos Aires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski
    • Entre Ríos Province
      • Concepción del Uruguay, Entre Ríos Province, Argentina, 3260
        • Centro de Medicina Respiratoria
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, 5500
        • Fundación Scherbovsky
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Fundacion Estudios Clinicos (FECLIN)
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto Médico Fundación Grupo Colaborativo Rosario Invest
  • Bulgaria
    • Haskovo
      • Haskovo, Haskovo, Bulgaria, 6300
        • Medical Center Pulmo-2018 EOOD
    • Lovech
      • Lovech, Lovech, Bulgaria, 5500
        • Medical Center Medconsult Pleven, Lovech branch
    • Montana
      • Montana, Montana, Bulgaria, 3400
        • MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
    • Pazardzhik
      • Velingrad, Pazardzhik, Bulgaria, 4600
        • SHLTTRPD "Sveta Petka Balgarska" EOOD
    • Pernik
      • Dupnitsa, Pernik, Bulgaria, 2307
        • Specialized Hospital For Active Treatment Of Pulmonary Diseases Sv.Panteleymon EOOD
    • Plovdiv
      • Plovdiv, Plovdiv, Bulgaria, 4000
        • Dr. Filip Shterev IAPSMCPP EOOD
      • Plovdiv, Plovdiv, Bulgaria, 4000
        • Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
      • Plovdiv, Plovdiv, Bulgaria, 4004
        • Multiprofile Hospital for Active Treatment "St. Panteleimon "- Plovdiv
    • Ruse
      • Rousse, Ruse, Bulgaria, 7002
        • Medical Center Prolet EOOD - Pulmonary, Allergy Diseases
      • Rousse, Ruse, Bulgaria, 7002
        • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
    • Sliven
      • Sliven, Sliven, Bulgaria, 8800
        • Diagnostic consultative center 1 -Sliven
      • Sliven, Sliven, Bulgaria, 8800
        • MHAT Sliven to MMA Sofia
    • Sofia
      • Sofia, Sofia, Bulgaria, 1111
        • Medical Center Excelsior OOD, Base 2
      • Sofia, Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda University Hospital EAD
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1510
        • Medical Center Hera
      • Sofia, Sofia-Grad, Bulgaria, 1142
        • First Multiprofile Hospital for Active Treatment - Sofia
      • Sofia, Sofia-Grad, Bulgaria, 1202
        • Specialized Hospital For Active Treatment Of Pulmonary Diseases - Sofia EOOD
      • Sofia, Sofia-Grad, Bulgaria, 1233
        • National Multiprofile Transport Hospital (NMTB) - Internal Diseases
      • Sofia, Sofia-Grad, Bulgaria, 1407
        • Medical Center Excelsior OOD, Base 1
      • Sofia, Sofia-Grad, Bulgaria, 1680
        • DCC Convex EOOD
    • Stara Zagora
      • Stara Zagora, Stara Zagora, Bulgaria, 6000
        • Medical Center for Outpatient Care Preventsia 2000
    • Vratsa
      • Kozloduy, Vratsa, Bulgaria, 3320
        • Medical Center - Zdrave1
  • Chile
    • Santiago Metropolitan
      • Vitacura, Santiago Metropolitan, Chile, 7630226
        • Clinica Fundacion Medica San Cristobal
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520000
        • Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
  • Czechia
    • Hradec Králové Region
      • Broumov, Hradec Králové Region, Czechia, 550 01
        • EDUMED, s.r.o
    • Moravian-Silesian Region
      • Poruba, Moravian-Silesian Region, Czechia, 70800
        • Plicni ambulance Alveolus s.r.o.
    • Praha, Hlavní Mesto
      • Prague, Praha, Hlavní Mesto, Czechia, 14000
        • MEDICON a.s. - Plicni oddeleni
      • Prague, Praha, Hlavní Mesto, Czechia, 19061
        • Privatni plicni ambulance, s.r.o.
    • Rokycany
      • Rokycany, Rokycany, Czechia, 33701
        • Plicni ambulance Rokycany
    • South Moravian
      • Miroslav, South Moravian, Czechia, 671 72
        • MUDr. Pavlisova Ilona s.r.o.
    • Stredoceský Kraj
      • Brandýs nad Labem, Stredoceský Kraj, Czechia, 25001
        • MUDr. I. Cierna Peterova s.r.o.
      • Kralupy nad Vltavou, Stredoceský Kraj, Czechia, 278 01
        • Plicni ambulance Kralupy s.r.o.
    • Ústí nad Labem Region
      • Teplice, Ústí nad Labem Region, Czechia, 41501
        • Plicni stredisko Teplice s.r.o. - Plicni ordinace
      • Varnsdorf, Ústí nad Labem Region, Czechia, 40747
        • Pneumologie Varnsdorf s.r.o.
  • Georgia
    • Adjara
      • Batumi, Adjara, Georgia, 6010
        • LTD "High technology hospital MEDCENTER"
    • Hvemo Kartli
      • Rustavi, Hvemo Kartli, Georgia, 3700
        • LTD Clinic Rustavi
    • K'alak'i T'bilisi
      • Tbilisi, K'alak'i T'bilisi, Georgia, 102
        • A. Aladashvili clinic LLC
      • Tbilisi, K'alak'i T'bilisi, Georgia, 112
        • LTD "Israel-Georgian Medical Research Clinic Healthycore"
      • Tbilisi, K'alak'i T'bilisi, Georgia, 144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
      • Tbilisi, K'alak'i T'bilisi, Georgia, 159
        • Center of Allergy and Immunology - Allergy/Immunology-Reumatology
      • Tbilisi, K'alak'i T'bilisi, Georgia, 159
        • LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
      • Tbilisi, K'alak'i T'bilisi, Georgia, 159
        • Ltd Diacor
    • Kvemo Kartli
      • Marneuli, Kvemo Kartli, Georgia, 3000
        • LTD MARNECOR - Internal Medicine
  • Germany
    • Bavaria
      • Aschaffenburg, Bavaria, Germany, 63739
        • Gemeinschaftspraxis Rolke / Rückert
      • Augsburg, Bavaria, Germany, 86150
        • Pneumologie, Schlafmedizin und Onkologie am Diako
      • Bamberg, Bavaria, Germany, 96049
        • CIMS Studienzentrum Bamberg
      • München, Bavaria, Germany, 82131
        • Asklepios Lungenklinik Gauting GmbH - Zentrum für Pneumologie und Thoraxchirurgie
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 3050
        • MECS GmbH
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22299
        • ME Clinical Respiratory Research
    • Hesse
      • Darmstadt, Hesse, Germany, 64283
        • Pneumostudien Darmstadt GmbH
      • Frankfurt am Main, Hesse, Germany, 60596
        • IKF Pneumologie GmbH & Co. KG
      • Neu-Isenburg, Hesse, Germany, 63263
        • Ballenberger, Freytag, Wenisch
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30167
        • Pneumologische Praxis und Schlaflabor - Lutz Volgmann
      • Peine, Lower Saxony, Germany, 31224
        • Studienzentrum Dr.med. Christian Schlenska - Pneumologie/Allergologie/Innere Medizin
    • North Rhine-Westphalia
      • Rheine, North Rhine-Westphalia, Germany, 48431
        • framol-med GmbH
      • Witten, North Rhine-Westphalia, Germany, 58452
        • Gemeinschaftspraxis Franz, Weber
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55128
        • IKF Pneumologie GmbH & Co. KG
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 6108
        • Pneumologicum-Halle - Pulmonary
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23552
        • Velocity Clinical Research Germany GmbH
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10119
        • Studienpraxis Berlin-Brandenburg
      • Berlin, State of Berlin, Germany, 10717
        • Lungenpraxis Hohenzollerndamm
      • Berlin, State of Berlin, Germany, 10787
        • Velocity Clinical Research Germany GmbH
      • Berlin, State of Berlin, Germany, 12203
        • MECS Research GmbH
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7635
        • Infer-Med Kft.
    • Borsod-Abauj Zemplen county
      • Edelény, Borsod-Abauj Zemplen county, Hungary, H-3780
        • Koch Róbert Kórház és Rendel?intézet
    • Budapest
      • Budapest, Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Budapest, Hungary, 1044
        • Pulmo Protect Kft.
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Kek Pont Aquagyogyaszat Kft.
    • Csongrád megye
      • Bordány, Csongrád megye, Hungary, 6720
        • Aranyklinika Kft
    • Debrecen
      • Debrecen, Debrecen, Hungary, H-4012
        • Debreceni Egyetem Klinikai Központ - Tüdőgyógyászati Klinika
    • Hajdú-Bihar
      • Hajdúnánás, Hajdú-Bihar, Hungary, 4080
        • Szalay Janos Rendelointezet
    • Heves County
      • Püspökladány, Heves County, Hungary, 4150
        • Puspokladanyi Egeszsegugyi Szolgaltato Nonprotfit Kft
    • Pest County
      • Gödöllő, Pest County, Hungary, 2100
        • Erzsebet Gondozohaz Kft.
    • Veszprém megye
      • Farkasgyepű, Veszprém megye, Hungary, 8582
        • Farkasgyepui Tudogyogyintezet
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500036
        • Astar Prime Hospitals - Internal Medicine
      • Nellore, Andhra Pradesh, India, 524004
        • A.C. Subba Reddy Government Medical College (ACSR) - Pulmonary
      • Vijayawada, Andhra Pradesh, India, 520008
        • Siddhartha Medical College
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Medanta Medicity
      • Rohtak, Haryana, India, 124001
        • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) - Pandit Bhagwat Dayal Sharma
    • Maharashtra
      • Kolhāpur, Maharashtra, India, 416002
        • Rajarshi Chhatrapati Shahu Maharaj (RCSM) Government Medical College & CPR Hospital
      • Nagpur, Maharashtra, India, 440009
        • Shree Hospital & Critical Care Centre
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110 001
        • Sir Ganga Ram Hospital (SGRH) - Gastroenterology and Hepatology
    • Rajasthan
      • Bikaner, Rajasthan, India, 334001
        • S.P Medical College and Group of Hospitals, Bikaner
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Shri Mahant Indiresh Hospital
    • West Bengal
      • Belgaum, West Bengal, India, 590010
        • JNMC
      • Kolkata, West Bengal, India, 700014
        • NRS Medical college
  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland, D15 X40D
        • Connolly Hospital
      • Tallaght, Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital
    • Louth
      • Drogheda, Louth, Ireland, A92VW28
        • Our Lady of Lourdes Hospital
  • Latvia
    • Jūrmala
      • Jūrmala, Jūrmala, Latvia, LV-2010
        • Veselibas Centru apvieniba AS, Dubultu poliklinika
    • Liepaja
      • Liepāja, Liepaja, Latvia, LV-3414
        • Liepaja Regional Hospital
    • Riga
      • Riga, Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital - Center of Lung Diseases
      • Riga, Riga, Latvia, LV-1013
        • SIA "Profesora Skrides Sirds klīnika"
  • Lithuania
    • Kaunas County
      • Kaunas, Kaunas County, Lithuania, LT 50161
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
      • Kaunas, Kaunas County, Lithuania, LT-47116
        • Lithuanian University of Health Sciences Kaunas Hospital
    • Klaipėda County
      • Klaipėda, Klaipėda County, Lithuania, LT-92231
        • Republic Klaipeda Hospital
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • Universiti Malaya Medical Centre
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 53000
        • Institut Perubatan Respiratori
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47500
        • Thomson Hospital Kota Damansara
      • Shah Alam, Selangor, Malaysia, 68100
        • Universiti Teknologi Mara
  • Philippines
    • Bulacan
      • Marilao, Bulacan, Philippines, 3019
        • Marilao Saint Michael Family Hospital, Inc. - Research Room
    • Cavite
      • Dasmariñas, Cavite, Philippines, 4114
        • CARE Clinical Trial Group Inc.
    • Cebu
      • Cebu, Cebu, Philippines, 6000
        • De Asis Medical Clinic (Norzel Medical and Diagnostic Clinic)
      • Cebu, Cebu, Philippines, 6000
        • Perpetual succour hospital of Cebu INC
    • Iloilo
      • Iloilo City, Iloilo, Philippines, 5000
        • Iloilo Doctors' Hospital Inc.
    • National Capital Region
      • Mandaluyong, National Capital Region, Philippines, 1552
        • Health Cube Medical Clinics
  • Poland
    • Greater Poland Voivodeship
      • Bydgoszcz, Greater Poland Voivodeship, Poland, 85-796
        • Centrum medyczne Pratia Bydgoszcz
      • Poznan, Greater Poland Voivodeship, Poland, 61-578
        • Specjalistyczna Przychodnia Lekarska Alergo - Med Sp. z o.o.
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia McM Krakow
      • Krakow, Lesser Poland Voivodeship, Poland, 30-033
        • Centrum Medyczne All-Med
    • Lubusz Voivodeship
      • Lublin, Lubusz Voivodeship, Poland, 20-078
        • Clinical Best Solutions
      • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
        • Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o. o.
    • Lódzkie
      • Skierniewice, Lódzkie, Poland, 96-100
        • Velocity Skierniewice Sp. z o.o.
    • Masovian Voivodeship
      • Sochaczew, Masovian Voivodeship, Poland, 96-500
        • RCMed Oddzial Sochaczew
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-051
        • Prywatny Gabinet Lekarski
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-205
        • EMED Centrum Uslug Medycznych Ewa Smialek
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-044
        • Centrum Medycyny Oddechowej, Mroz Spolka Jawna
      • Bialystok, Podlaskie Voivodeship, Poland, 15-879
        • ClinicMed Daniluk, Nowak Sp. Komandytowa
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne - Klinika Alergologii
    • Warmian-Masurian Voivodeship
      • Katowice, Warmian-Masurian Voivodeship, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o. o.
  • Romania
    • Brașov County
      • Brasov, Brașov County, Romania, 500283
        • Centrul Medical de Diagnostic si Tratament Ambulator Neomed - Multiple Specialties
    • Bucharest
      • Bucharest, Bucharest, Romania, 11025
        • Centrul Medical Sana
      • Bucharest, Bucharest, Romania, 50521
        • Medsana CM Cotroceni Pulmonology
      • Bucharest, Bucharest, Romania, 61334
        • Rimmed Centru Medical Pulmonology
      • Bucharest, Bucharest, Romania, 616962
        • Anima Specialty Medical Services
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400275
        • CM Pneumologie Dr Mincu Bogdan
      • Cluj-Napoca, Cluj, Romania, 400371
        • Sp Pneumoftizio Leon Daniello CJ
    • Constanța County
      • Palazu Mare, Constanța County, Romania, 900002
        • Sp.Clinic Pneumo Constanta Pulmon 2
    • Ilfov
      • Bragadiru, Ilfov, Romania, 77025
        • Angisan Grup
      • Bucuresti, Ilfov, Romania, 30303
        • Fundatia Dr. Victor Babes
    • Olt
      • Dobrosloveni, Olt, Romania, 237143
        • Clintrial Medical Center
    • Timiș County
      • Timișoara, Timiș County, Romania, 300310
        • Sp Dr Victor Babes Timisoara Pulmon
  • Serbia
    • Vojvodina
      • Kamenitz, Vojvodina, Serbia, 21204
        • Institute for Pulmonary Diseases of Vojvodina, Clinic for Pulmonary Oncology
  • Slovakia
    • Banská Bystrica Region
      • Banská Bystrica, Banská Bystrica Region, Slovakia, 97517
        • FNsP F.D.R. Banska Bystrica - Pneumologie a ftizeologie
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 85101
        • Pneumomed s.r.o. - Pneumo-Alergo Centrum
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 01
        • MEDEKA s.r.o. - Pneumologia a ftizeologia
      • Spišská Nová Ves, Košice Region, Slovakia, 052 01
        • Plucna ambulancia Hrebenar s.r.o.
    • Nitra Region
      • Levice, Nitra Region, Slovakia, 934 01
        • ZAPA JJ s.r.o. - Pneumologia a ftizeologia
      • Nové Zámky, Nitra Region, Slovakia, 940 01
        • DIONEA, s.r.o. - Ambul. pneumologie
    • Presov
      • Humenné, Presov, Slovakia, 066 01
        • INSPIRO s.r.o. - MUDr. Golubov Alexander - Pneumologia a ftizeologia
      • Kežmarok, Presov, Slovakia, 6001
        • PAFA, s.r.o.
  • South Korea
    • Gang'Weondo [Kang-won-do]
      • Wŏnju, Gang'Weondo [Kang-won-do], South Korea, 26426
        • Yonsei University, Wonju Severance Christian Hospital - Pulmonology
    • Gyeonggido [Kyonggi-do]
      • Seongnam-si, Gyeonggido [Kyonggi-do], South Korea, 13620
        • Seoul National University Bundang Hospital - Pulmonology
    • Incheon Gwang'Yeogsi [Inch'n-Kwangyokshi]
      • Incheon, Incheon Gwang'Yeogsi [Inch'n-Kwangyokshi], South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
    • Seoul
      • Seoul, Seoul, South Korea, 2841
        • Korea University Anam Hospital - Pulmonology
      • Seoul, Seoul, South Korea, 5030
        • Konkuk University Medical Center
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 3312
        • Eunpyeong St. Mary's Hospital
    • Seoul Teugbyeolsi [Seoul-T'Ukpyolshi]
      • Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], South Korea, 2447
        • Kyung Hee Universtiy Hospital
      • Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], South Korea, 3722
        • Severance Hospital, Yonsei University Health System - Pulmonary
  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 7120
        • Hospital Universitario Son Espases
    • Cantabria
      • Torrelavega, Cantabria, Spain, 39300
        • Hospital Sierrallana - Neumologia
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital de Jerez de la Frontera
    • Extremadura
      • Cáceres, Extremadura, Spain, 10003
        • Hospital San Pedro de Alcántara
    • Granada
      • Granada, Granada, Spain, 18014
        • Hospital Universitario Virgen de Las Nieves
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Madrid, Spain, 28046
        • Hospital Universitario La Paz - Neumologia
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
    • Málaga
      • Benalmádena, Málaga, Spain, 29630
        • Vithas Xanit International Hospital - Gastroenterology
      • Marbella, Málaga, Spain, 29603
        • Hospital Quirónsalud Marbella
      • Málaga, Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Neumología
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Hospital Clinico Universitario De Valencia - Neumologia
  • Taiwan
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 80756
        • KMU Chung-Ho Memorial Hospital
      • Kaohsiung City, Kaohsiung, Taiwan, 833401
        • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
    • Taichung
      • Taichung, Taichung, Taiwan, 407219
        • Taichung Veterans General Hospital - Chest Medicine
      • Taichung, Taichung, Taiwan, 433
        • Kuang Tien General Hospital - XiangShang
    • Tainan
      • Tainan, Tainan, Taiwan, 71004
        • Chi Mei Medical Center - YongKang - Pulmonary Medicine
    • Taipei
      • Taipei, Taipei, Taiwan, 110
        • Taipei Medical University - Taipei Medical University Hospital - Internal Medicine
    • Taoyuan
      • Taoyuan, Taoyuan, Taiwan, 333423
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Pulmonary
    • Yunlin
      • Douliu, Yunlin, Taiwan, 640203
        • National Taiwan University Hospital - Yunlin Branch - Douliou
  • Ukraine
    • Cherkasy Oblast
      • Cherkasy, Cherkasy Oblast, Ukraine, 18009
        • KNP "Cherkaska oblasna likarnia"
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • KNP"Ts inf.zakhv.Iv-Frank.obl.rady"
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76019
        • Likuv.-diahn. tsentr Sviatoho Luky
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ukraine, 2000
        • MTs "Universalna klinika "Oberih"
      • Kyiv, Kyiv Oblast, Ukraine, 3038
        • DU "NNTs im. Yanovskoho"
      • Kyiv, Kyiv Oblast, Ukraine, 3049
        • Klin.likarnia na zal.transporti №2
    • Luhansk Oblast
      • Kyiv, Luhansk Oblast, Ukraine, 3038
        • DU "NNTs im. Yanovskoho"
    • Ternopil Oblast
      • Ternopil, Ternopil Oblast, Ukraine, 46002
        • MTs "Klinika Hospodarskykh"
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21001
        • Medychnyi tsentr "Puls"
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88009
        • Uzh.miska bahatoprofilna klin.lik.
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88017
        • Lik.z nevidkl. staniv ta ekstr.dop.
    • Zhytomyr Oblast
      • Zhytomyr, Zhytomyr Oblast, Ukraine, 10002
        • KNP "Likarnia №1" Zhytom.misk.rady
  • United Kingdom
    • Bedfordshire
      • Milton Keynes, Bedfordshire, United Kingdom, MK15 0DU
        • Bioluminux Clinical Research
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2SQ
        • Synexus Midlands Clinical Research Centre
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
        • Velocity Clinical Research - High Wycombe
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S40 4AA
        • Royal Primary Care - Ashgate
    • Devon
      • Newton Abbot, Devon, United Kingdom, TQ13 7AP
        • Ashburton Surgery
    • Essex
      • Romford, Essex, United Kingdom, RM1 3PJ
        • Velocity Romford
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • NHS Greater Glasgow & Clyde - Gartnavel General Hospital - Respiratory
      • Glasgow, Glasgow City, United Kingdom, G51 4TY
        • Panthera Biopartners - Glasgow
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9QB
        • Panthera Biopartners - Preston
    • Leeds
      • Leeds, Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust - St James' University Hospital
    • Liverpool
      • Metropolitan Borough of Wirral, Liverpool, United Kingdom, CH62 6EE
        • FutureMeds Wirral
    • London
      • Enfield, London, United Kingdom, EN3 4GS
        • Panthera Biopartners - North London
    • Manchester
      • Rochdale, Manchester, United Kingdom, OL11 4AU
        • Panthera Biopartners - Manchester
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • Lakeside Healthcare
    • Scotland
      • Glasgow, Scotland, United Kingdom, G20 7BE
        • Futuremeds - Glasgow
    • Sheffield
      • Sheffield, Sheffield, United Kingdom, S2 5FX
        • Panthera Biopartners - Sheffield
    • United Kingdom
      • Dundee, United Kingdom, United Kingdom, DD1 9SY
        • NHS Tayside - Ninewells Hospital
      • Newcastle, United Kingdom, United Kingdom, NE6 1SG
        • FutureMeds - Newcastle
      • Reading, United Kingdom, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
    • Wirral
      • Metropolitan Borough of Wirral, Wirral, United Kingdom, TS19 8PE
        • Futuremeds -Teesside
    • York
      • York, York, United Kingdom, YO24 4LJ
        • Panthera Biopartners - York
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research Inc.
      • Encino, California, United States, 91436
        • PulmoCrit Associates
      • Lomita, California, United States, 90717-2101
        • Torrance Clinical Research Institute
      • Pomona, California, United States, 91767
        • Dream Team Clinical Research
      • San Diego, California, United States, 92120
        • Apex Clinical Research
      • Westminster, California, United States, 92683
        • Allianz Research Institute
    • Florida
      • Doral, Florida, United States, 33122
        • D&H Doral Research Center, LLC
      • Hialeah, Florida, United States, 33010
        • Qway Research, LLC
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33173
        • MplusM - ITB Research
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical Research,LLC
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Velocity Clinical Research-Savannah - Internal Medicine
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Christie Clinic, LLC
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research-Rockville
      • White Marsh, Maryland, United States, 21162
        • Chesapeake Clinical Research, Inc
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • HealthPartners
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • American Health Research, Inc.
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research, Anderson
      • Columbia, South Carolina, United States, 29201
        • SleepMed Inc.
      • Greenville, South Carolina, United States, 29615
        • Velocity Clinical Research, Gaffney
      • Spartanburg, South Carolina, United States, 29303
        • Velocity Clinical Research, Spartanburg - Pulmonology
      • Union, South Carolina, United States, 29379
        • Velocity Clinical Research- Union
    • Texas
      • El Paso, Texas, United States, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, United States, 77024
        • Victorium Clinical Research
      • Houston, Texas, United States, 77036
        • Synergy Groups Medical LLC
      • Houston, Texas, United States, 77061
        • Synergy Groups Medical LLC
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center
      • Missouri City, Texas, United States, 77459
        • Synergy Groups Medical LLC
    • Virginia
      • Suffolk, Virginia, United States, 23435
        • Velocity Clinical Research - Suffolk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Verekitug (UPB-101) formulated solution
Other Names:
  • UPB-101
Other: Placebo
Matching Placebo to Verekitug (UPB-101)
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
Verekitug (UPB-101) formulated solution
Other Names:
  • UPB-101
Other: Placebo
Matching Placebo to Verekitug (UPB-101)
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
Matching Placebo to Verekitug (UPB-101)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized rate of moderate or severe COPD exacerbation events
Time Frame: From Day 1 (Baseline) up to Week 108
From Day 1 (Baseline) up to Week 108

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)
Time Frame: From Day 1 (Baseline) to Week 60
From Day 1 (Baseline) to Week 60
Annualized rate of severe COPD exacerbation events
Time Frame: From Day 1 (Baseline) up to Week 108
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
From Day 1 (Baseline) to Week 60
Proportion of participants with SGRQ improvement of >4 points
Time Frame: At Week 60
At Week 60
Incidence of treatment-emergent adverse events and serious adverse events
Time Frame: From Day 1 (Baseline) up to Week 112
From Day 1 (Baseline) up to Week 112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Upstream Bio Inc.

Investigators

  • Study Director: Justin Salciccioli, MD, Upstream Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 12, 2025

First Posted (Actual)

May 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPB-CP-06
  • 2025-520488-42-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe