A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

Last updated: April 25, 2025
Sponsor: Upstream Bio Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

Verekitug (UPB-101)

Clinical Study ID

NCT06196879
UPB-CP-04
2023-507410-27-00
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).

  • Age 18 to 80 years of age (inclusive) at the time of consent.

  • Physician-diagnosed asthma for at least 12 months prior to Visit 1.

  • Participant has evidence of bronchodilator (BD) reversibility as documented byeither historical reversibility (within 12 months prior to study entry) orreversibility during screening.

  • Documented treatment with a total daily dose of either medium or high dose inhaledcorticosteroids (ICS) for at least 3 months. Participants on medium dose ICS mustalso have been taking at least one additional maintenance asthma controllermedication for at least 3 months.

  • Documented history of asthma exacerbation(s) within 12 months of Visit 1.

  • Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (>=) 1.5 atscreening and randomization.

  • Participant must have a pre-BD FEV1 value of >=30 percent (%) and <=80% predicted atScreening.

  • Minimum compliance with daily diary and background asthma medication(s) as capturedin the daily diary during the Run-in Period.

  • Agrees to follow the required contraceptive techniques/methods.

  • Female or male participant agrees not to donate eggs or sperm, respectively, for aperiod of 120 days after the last dose of the study drug intervention or at theFinal Visit, whichever occurs last.

Exclusion

Exclusion Criteria:

  • Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1or during the Screening/Run-in Period.

  • Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of itsexcipients.

  • Previous biologics, including those for asthma treatment, for which the appropriatewashout period is not fulfilled prior to Visit 1. If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied.

  • Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 orplans to begin therapy or change dosing during the study.

  • For participants taking oral corticosteroids (OCS), the dose has not been stable forat least 2 weeks prior to Visit 1 and/or is >10 milligram (mg) daily, or >20 mgevery other day.

  • Evidence of active or suspected bacterial, viral, fungal, or parasitic infectionswithin 2 weeks prior to Visit 1.

  • History compatible with or diagnosis of a parasitic infection and has not beentreated or has not responded to standard of care therapy.

  • Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuffusers or participants with a smoking history >=10 pack years. (Former nicotinesmokers with a smoking history of <10 pack years, former nicotine vapers and formersnuff users must have stopped for at least 6 months prior to Visit 1 to beeligible).

  • Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tractsymptoms within 28 days before Visit 1.

  • Pregnant or breastfeeding or planning to become pregnant or breastfeed during thestudy or unwilling to use adequate birth control, if of reproductive potential andsexually active.

Study Design

Total Participants: 436
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 27, 2024
Estimated Completion Date:
June 11, 2026

Study Description

This is a multicenter, randomized, placebo-controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC). A total of approximately 436 adult participants with severe asthma are planned for enrolment and will be randomized in a 1:1:1:1 ratio to receive verekitug (UPB-101) at doses of 100 mg every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), and 100 mg every 24 weeks (Q24W), or placebo administered SC. In order to maintain the blinding of different doses, all participants will receive 2 SC injections at each dosing visit. This study consists of a Screening/Run-In Period (approximately 4 weeks), Treatment Period (up to 60 weeks with a minimum of 24 weeks) and Follow-up Period (ending approximately 16 weeks after the last administration of study intervention).

Connect with a study center

  • Centro de Medicina Respiratoria

    Concepción Del Uruguay, Entre Rios E3260
    Argentina

    Active - Recruiting

  • Fundacion Scherbovsky

    Ciudad de Mendoza, Mendoza 5500
    Argentina

    Active - Recruiting

  • Fundacion Estudios Clinicos (FECLIN)

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Instituto Especialidades de la Salud Rosario

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Investigaciones En Patologias Respiratorias

    San Miguel De Tucumán, Tucumán CP T4000IAP
    Argentina

    Active - Recruiting

  • Office of Hector H. Altieri MD

    San Miguel De Tucumán, Tucumán 4000
    Argentina

    Active - Recruiting

  • Fundacion Cidea

    Caba, C1121ABE
    Argentina

    Active - Recruiting

  • InAER

    Caba, C1425BEN
    Argentina

    Active - Recruiting

  • CARE: Centro de Alergia y Enfermedades Respiratorias

    Ciudad Autónoma de Buenos Aires, C1414AIF
    Argentina

    Active - Recruiting

  • Fundacion Respirar - Centro Medico Dra. De Salvo

    Ciudad Autónoma de Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio

    Córdoba, X5003DCE
    Argentina

    Active - Recruiting

  • Centro Medico Dharma

    Mendoza, M5500
    Argentina

    Active - Recruiting

  • INSARES

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • MHAT "Rahila Angelova" Pernik

    Pernik, 2300
    Bulgaria

    Active - Recruiting

  • UMHAT Sveti Georgi

    Plovdiv, 4001
    Bulgaria

    Active - Recruiting

  • Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd

    Ruse, 7000
    Bulgaria

    Active - Recruiting

  • DCC Convex

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • Medconsult Pleven

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • Medical Center Excelsior

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Medical Center HERA EOOD

    Sofia, 1510
    Bulgaria

    Active - Recruiting

  • Medical center Pulmovizhyn

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • Medical Center New Rehabilitation Center EOOD

    Stara Zagora, 6001
    Bulgaria

    Active - Recruiting

  • MC Zdrave 1

    Vratsa, 3320
    Bulgaria

    Active - Recruiting

  • Dynamic Drug Advancement

    Ajax, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • Ottawa Allergy Research Corp

    Ottawa, Ontario K1H 1E4
    Canada

    Active - Recruiting

  • Toronto Allergists

    Toronto, Ontario M5G1E2
    Canada

    Active - Recruiting

  • Winchester Hospital

    Winchester, Ontario K0C 2K0
    Canada

    Active - Recruiting

  • Fundacion Medica San Cristobal

    Santiago, Metropolitana 7630226
    Chile

    Active - Recruiting

  • Icegclinic

    Santiago, Region Metropolitana 8241479
    Chile

    Active - Recruiting

  • Centro Médico BIOREUMA

    Concepción, 4070280
    Chile

    Active - Recruiting

  • CIMER

    Providencia, 7500657
    Chile

    Active - Recruiting

  • Sociedad medica Sy G Limitada

    Santiago, 7501126
    Chile

    Active - Recruiting

  • Fakultni Nemocnice u Sv. Anny v Brne

    Brno, Czech Republic 602 00
    Czechia

    Active - Recruiting

  • Alergologie a imunologie Hofstetr Alois MUDr. s.r.o.

    Jihlava, Czech Republic 586 01
    Czechia

    Active - Recruiting

  • Plicni Stredisko Teplice S.R.O

    Teplice, Czech Republic 415 01
    Czechia

    Active - Recruiting

  • PNEUMOLOGIE VARNSDORF s.r.o.

    Varnsdorf, Czech Republic 407 47
    Czechia

    Active - Recruiting

  • KPPK Studienzentrum

    Koblenz, Rheinland-Pfalz 56068
    Germany

    Active - Recruiting

  • POIS Sachsen GmbH

    Leipzig, Sachsen 04347
    Germany

    Active - Recruiting

  • Pneumologisches Studienzentrum

    Berlin, 10961
    Germany

    Active - Recruiting

  • RCMS Dr. Linnhoff

    Berlin, 10717
    Germany

    Active - Recruiting

  • RCMS/Lungenpraxis Hohenzollerndamm

    Berlin, 10717
    Germany

    Active - Recruiting

  • Velocity Clinical Research Germany , Berlin

    Berlin, 10787
    Germany

    Active - Recruiting

  • ME Clinical Respiratory Research Hamburg GmbH

    Hamburg, 22299
    Germany

    Active - Recruiting

  • IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

    Hessen, 60596
    Germany

    Active - Recruiting

  • IKF Pneumologie GmbH & Co. KG

    Mainz, 55128
    Germany

    Active - Recruiting

  • SSD Asma Grave e Malattie Rare del Polmone, AOU San Luigi Gonzaga

    Orbassano, Torino 10043
    Italy

    Active - Recruiting

  • Ospedale San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • UOSD Allergologia e Immunodeficienze dell'A.O.U. Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico "San Matteo" - SC Pneumologia'

    Pavia, 27100
    Italy

    Active - Recruiting

  • KKR Sapporo Medical Center

    Sapporo, Hokkaido 062-0931
    Japan

    Active - Recruiting

  • Oji General Hospital

    Tomakomai, Hokkaido 053-8506
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama-shi, Kanagawa 232-0024
    Japan

    Active - Recruiting

  • Osaka Habikino Medical Center

    Habikino, Osaka 583-8588
    Japan

    Active - Recruiting

  • Kishiwada City Hospital

    Kishiwada, Osaka 596-8501
    Japan

    Active - Recruiting

  • Fukuwa Clinics

    Chuo-ku, Tokyo 104-0031
    Japan

    Active - Recruiting

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo 103-0027
    Japan

    Active - Recruiting

  • National Hospital Organization Ibarakihigashi National Hospital

    Ibaraki, 319-1113
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051
    Japan

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju, Chubgbuk 28644
    Korea, Republic of

    Active - Recruiting

  • Eunpyeong St. Marys Hospital

    Seoul, Korea 03312
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Marys Hospital

    Seoul, Republic of Korea 06591
    Korea, Republic of

    Active - Recruiting

  • Soonchunhyang University Bucheon Hospital

    Bucheon, 14584
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Hospital

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital

    Seoul, 2447
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 6351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Health System - Severance Hospital

    Seoul, 3722
    Korea, Republic of

    Active - Recruiting

  • "ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

    Wroclaw, Dolnoslaskie Voivodeship 53-201
    Poland

    Active - Recruiting

  • Lekarze Specjalisci - J. Malolepszy I Partnerzy

    Wroclaw, Dolnoslaskie Voivodeship 54-239
    Poland

    Active - Recruiting

  • Centrum Badan Klinicznych

    Wrocław, Dolnoslaskie Voivodeship 51-162
    Poland

    Active - Recruiting

  • Malopolskie Centrum Alergologii

    Krakow, Malopolskie Voivodeship 31-624
    Poland

    Active - Recruiting

  • Nzoz Atopia

    Krakow, Malopolskie Voivodeship 31-159
    Poland

    Active - Recruiting

  • Centrum Medyczne All-Med Spolka Komandytowa

    Kraków, Malopolskie Voivodeship 30-033
    Poland

    Active - Recruiting

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

    Tarnow, Malopolskie Voivodeship 33-100
    Poland

    Active - Recruiting

  • EMED Centrum Uslug Medycznych

    Rzeszow, Podkarpackie Voivodeship 35-205
    Poland

    Active - Recruiting

  • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

    Rzeszow, Podkarpackie Voivodeship 35-051
    Poland

    Active - Recruiting

  • Centrum Medycyny Oddechowej, Mroz Spolka Jawna

    Białystok, Podlaskie Voivodeship 15-044
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii

    Gdańsk, Pomorskie Voivodeship 80-214
    Poland

    Active - Recruiting

  • Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, Swietokrzyskie 27-400
    Poland

    Active - Recruiting

  • Newtown Clinical Research Centre

    Johannesburg, Gauteng 2001
    South Africa

    Active - Recruiting

  • Emmed Research

    Pretoria, Gauteng 0002
    South Africa

    Active - Recruiting

  • FCRN Clinical Trial Centre

    Vereeniging, Gauteng 1935
    South Africa

    Active - Recruiting

  • St Augustine's Hospital/Dr. IA Abdullah

    Durban, KwaZulu Natal 4001
    South Africa

    Active - Recruiting

  • University of Cape Town Lung Institute

    Cape Town, Western Cape 7700
    South Africa

    Active - Recruiting

  • Synapta Clinical Research Centre

    Durban, 4001
    South Africa

    Active - Recruiting

  • Giromed Institute

    Girona, Barcelona 08017
    Spain

    Active - Recruiting

  • Hospital Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, East Yorkshire HU16 5JQ
    United Kingdom

    Active - Recruiting

  • Royal Liverpool University Hospital

    Liverpool, Merseyside L7 8XP
    United Kingdom

    Active - Recruiting

  • Ormeau Clinical Trials Ltd

    Belfast, N. Ireland BT7 2EB
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • Asthma/COPD Clinical Research Centre

    Glasgow, Scotland G12 0YN
    United Kingdom

    Active - Recruiting

  • St Peter's Hospital

    Chertsey, Surrey KT16 0PZ
    United Kingdom

    Active - Recruiting

  • Perth Royal Infirmary

    Perth, Tayside PH1 1NX
    United Kingdom

    Site Not Available

  • Heartlands Hospital, University Hospitals Birmingham NHS Trust

    Birmingham, West Midlands B9 5SS
    United Kingdom

    Active - Recruiting

  • Bradford Royal Infirmary

    Bradford, West Yorkshire BD9 6RJ
    United Kingdom

    Active - Recruiting

  • Duckworth Lane Clinical Research Facility

    Bradford, West Yorkshire BD9 6RJ
    United Kingdom

    Active - Recruiting

  • AllerVie Clinical Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Kern Research, Inc.

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Velocity Clinical Research - Lafayette LA

    Los Angeles, California 70508
    United States

    Active - Recruiting

  • Newport Native MD Inc

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • California Medical Research Associates Inc.

    Northridge, California 91324
    United States

    Active - Recruiting

  • Integrated Research of Inland Inc

    Upland, California 91786
    United States

    Active - Recruiting

  • Allergy & Asthma Clinical Research

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Allianz Research Institute

    Westminster, California 92683
    United States

    Active - Recruiting

  • Woodland Clinic Medical Group

    Woodland, California 95695
    United States

    Active - Recruiting

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • Advance Pharma Research

    Cutler Bay, Florida 33189
    United States

    Active - Recruiting

  • Unique Clinical Trials

    Doral, Florida 33172
    United States

    Active - Recruiting

  • Clinical Site Partners

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Clinical Site Partners, LLC dba Flourish Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Health and Life Research Institute, LLC

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Nouvelle Clinical Research

    Miami, Florida 33189
    United States

    Active - Recruiting

  • Phoenix Medical Research

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Research Institute of South Florida

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Anderson Allergy And Asthma, PA

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Edward Jenner Research Group, LLC

    Plantation, Florida 33317
    United States

    Active - Recruiting

  • R&B Medical Center

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Clinical Site Partners dba Flourish research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Pivotal Research Solutions

    Stonecrest, Georgia 30038
    United States

    Active - Recruiting

  • RNA America Health Sciences

    Sugar hill, Georgia 30518
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Velocity Clinical Research - Meridian

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Howard County Center for Lung and Sleep Medicine LLC

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Chesapeake Clinical Research Inc

    White Marsh, Maryland 21162
    United States

    Active - Recruiting

  • Exordia Medical Research Inc

    Fall River, Massachusetts 02723
    United States

    Active - Recruiting

  • Pulmonary Research Institute of Southeast Michigan

    Farmington Hills, Michigan 48336
    United States

    Active - Recruiting

  • AA MRC

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • AA Medical Research Center

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • M3 Wake Research

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Urban Health Plan INC

    Bronx, New York 10459
    United States

    Active - Recruiting

  • Advanced Respiratory and Sleep Medicine LLC

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Summit Research Group LLC

    Munroe Falls, Ohio 44262
    United States

    Active - Recruiting

  • Toledo Institute of Clinical Research Inc

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • OK Clinical Research, LLC

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • Velocity Clinical Research - Medford

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Velocity Clinical Research - Anderson

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

  • WR-Notus Clinical Research, LLC

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Horizon Clinical Research

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Alina Clinical Trials, LLC

    Dallas, Texas 75225
    United States

    Active - Recruiting

  • El Paso Pulmonary Association

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Greater Houston Memorial Pulmonary and Sleep

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Metroplex Pulmonary and Sleep Center Drive

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • Element Research Group

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • DM Clinical Tomball

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Velocity Clinical Research

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • University of Wisconsin--Madison

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.