A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
2 other identifiers
interventional
479
15 countries
155
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2024
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2023
CompletedFirst Posted
Study publicly available on registry
January 9, 2024
CompletedStudy Start
First participant enrolled
February 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2026
CompletedMay 1, 2026
April 1, 2026
1.8 years
December 24, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Asthma Exacerbation Rate (AAER)
An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours.
Baseline up to Week 60
Secondary Outcomes (4)
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60
Baseline to Week 60
Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60
Baseline to Week 60
Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60
Baseline to Week 60
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Up to Week 64
Study Arms (4)
Verekitug (UPB-101): 100 mg Q12W / Placebo
EXPERIMENTALParticipants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48.
Verekitug (UPB-101): 400 mg Q24W / Placebo
EXPERIMENTALParticipants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
Verekitug (UPB-101): 100 mg Q24W / Placebo
EXPERIMENTALParticipants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
Placebo
PLACEBO COMPARATORParticipants 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 48.
Interventions
Verekitug (UPB-101) formulated solution
Verekitug (UPB-101) matching placebo
Eligibility Criteria
You may qualify if:
- 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 by either historical reversibility (within 12 months prior to study entry) or reversibility during screening.
- Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication 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 at screening and randomization.
- Participant must have a pre-BD FEV1 value of \>=30 percent (%) and \<=80% predicted at Screening.
- Minimum compliance with daily diary and background asthma medication(s) as captured in 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 a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.
You may not qualify if:
- Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period.
- Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
- Previous biologics, including those for asthma treatment, for which the appropriate washout 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 or plans to begin therapy or change dosing during the study.
- For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is \>10 milligram (mg) daily, or \>20 mg every other day.
- Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1.
- History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.
- Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history \>=10 pack years. (Former nicotine smokers with a smoking history of \<10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible).
- Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1.
- Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (155)
AllerVie Clinical Research
Birmingham, Alabama, 35209, United States
Kern Research, Inc.
Bakersfield, California, 93301, United States
Velocity Clinical Research - Lafayette LA
Los Angeles, California, 70508, United States
Newport Native MD Inc
Newport Beach, California, 92663, United States
California Medical Research Associates Inc.
Northridge, California, 91324, United States
Integrated Research of Inland Inc
Upland, California, 91786, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598, United States
Allianz Research Institute
Westminster, California, 92683, United States
Woodland Clinic Medical Group
Woodland, California, 95695, United States
National Jewish Health
Denver, Colorado, 80206, United States
Advance Pharma Research
Cutler Bay, Florida, 33189, United States
Unique Clinical Trials
Doral, Florida, 33172, United States
Health and Life Research Institute, LLC
Miami, Florida, 33155, United States
Phoenix Medical Research
Miami, Florida, 33165, United States
Research Institute of South Florida
Miami, Florida, 33173, United States
Nouvelle Clinical Research
Miami, Florida, 33189, United States
Anderson Allergy And Asthma, PA
Orlando, Florida, 32806, United States
Edward Jenner Research Group, LLC
Plantation, Florida, 33317, United States
R&B Medical Center
Tampa, Florida, 33614, United States
Clinical Site Partners dba Flourish research
Winter Park, Florida, 32789, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
Pivotal Research Solutions
Stonecrest, Georgia, 30038, United States
RNA America Health Sciences
Sugar Hill, Georgia, 30518, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Velocity Clinical Research - Meridian
Meridian, Idaho, 83642, United States
Howard County Center for Lung and Sleep Medicine LLC
Columbia, Maryland, 21044, United States
Chesapeake Clinical Research Inc
White Marsh, Maryland, 21162, United States
Exordia Medical Research Inc
Fall River, Massachusetts, 02723, United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
M3 Wake Research
Las Vegas, Nevada, 89106, United States
Urban Health Plan INC
The Bronx, New York, 10459, United States
Advanced Respiratory and Sleep Medicine LLC
Huntersville, North Carolina, 28078, United States
Summit Research Group LLC
Munroe Falls, Ohio, 44262, United States
Toledo Institute of Clinical Research Inc
Toledo, Ohio, 43617, United States
OK Clinical Research, LLC
Edmond, Oklahoma, 73034, United States
Portland Clinical Research
Clackamas, Oregon, 97015, United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621, United States
WR-Notus Clinical Research, LLC
Charleston, South Carolina, 29414, United States
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Horizon Clinical Research
Cypress, Texas, 77429, United States
Alina Clinical Trials, LLC
Dallas, Texas, 75225, United States
AARA Research Center
Dallas, Texas, 75231, United States
El Paso Pulmonary Association
El Paso, Texas, 79902, United States
Greater Houston Memorial Pulmonary and Sleep
Houston, Texas, 77008, United States
Sante Clinical Research
Kerrville, Texas, 78028, United States
Mayflower Clinical
Marble Falls, Texas, 02747, United States
Metroplex Pulmonary and Sleep Center Drive
McKinney, Texas, 75069, United States
Element Research Group
San Antonio, Texas, 78258, United States
DM Clinical Tomball
Tomball, Texas, 77375, United States
Velocity Clinical Research
West Jordan, Utah, 84088, United States
University of Wisconsin--Madison
Madison, Wisconsin, 53792, United States
IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
San Juan Bautista, Buenos Aires, 1888, Argentina
Centro de Medicina Respiratoria
Concepción del Uruguay, Entre Ríos Province, E3260, Argentina
Fundacion Scherbovsky
Mendoza, Mendoza Province, 5500, Argentina
Fundacion Estudios Clinicos (FECLIN)
Rosario, Santa Fe Province, 2000, Argentina
Instituto Especialidades de la Salud Rosario
Rosario, Santa Fe Province, 2000, Argentina
Office of Hector H. Altieri MD
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, CP T4000IAP, Argentina
CARE: Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, C1414AIF, Argentina
Fundacion Respirar - Centro Medico Dra. De Salvo
Buenos Aires, C1426ABP, Argentina
Fundacion Cidea
Caba, C1121ABE, Argentina
InAER
CABA, C1425BEN, Argentina
Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio
Córdoba, X5003DCE, Argentina
INSARES
Mendoza, 5500, Argentina
Centro Medico Dharma
Mendoza, M5500, Argentina
MHAT "Rahila Angelova" Pernik
Pernik, 2300, Bulgaria
UMHAT Sveti Georgi
Plovdiv, 4001, Bulgaria
Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
Rousse, 7000, Bulgaria
Medical Center Excelsior
Sofia, 1407, Bulgaria
Medical Center HERA EOOD
Sofia, 1510, Bulgaria
DCC Convex
Sofia, 1680, Bulgaria
Medconsult Pleven
Sofia, 1756, Bulgaria
Medical center Pulmovizhyn
Sofia, 1756, Bulgaria
Medical Center New Rehabilitation Center EOOD
Stara Zagora, 6001, Bulgaria
MC Zdrave 1
Vratsa, 3320, Bulgaria
Dynamic Drug Advancement
Ajax, Ontario, L1S 2J5, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, K1H 1E4, Canada
Toronto Allergists
Toronto, Ontario, M5G1E2, Canada
Winchester Hospital
Winchester, Ontario, K0C 2K0, Canada
Fundacion Medica San Cristobal
Santiago, Santiago Metropolitan, 7630226, Chile
Icegclinic
Santiago, Santiago Metropolitan, 8241479, Chile
Centro Médico BIOREUMA
Concepción, 4070280, Chile
CIMER
Providencia, 7500657, Chile
Sociedad medica Sy G Limitada
Santiago, 7501126, Chile
Fakultni Nemocnice u Sv. Anny v Brne
Brno, Czech Republic, 602 00, Czechia
Alergologie a imunologie Hofstetr Alois MUDr. s.r.o.
Jihlava, Czech Republic, 586 01, Czechia
Plicni Stredisko Teplice S.R.O
Teplice, Czech Republic, 415 01, Czechia
PNEUMOLOGIE VARNSDORF s.r.o.
Varnsdorf, Czech Republic, 407 47, Czechia
KPPK Studienzentrum
Koblenz, Rhineland-Palatinate, 56068, Germany
POIS Sachsen GmbH
Leipzig, Saxony, 04347, Germany
RCMS/Lungenpraxis Hohenzollerndamm
Berlin, 10717, Germany
Velocity Clinical Research Germany , Berlin
Berlin, 10787, Germany
Pneumologisches Studienzentrum
Berlin, 10961, Germany
ME Clinical Respiratory Research Hamburg GmbH
Hamburg, 22299, Germany
IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
Hessen, 60596, Germany
IKF Pneumologie GmbH & Co. KG
Mainz, 55128, Germany
SSD Asma Grave e Malattie Rare del Polmone, AOU San Luigi Gonzaga
Orbassano, Torino, 10043, Italy
Ospedale San Martino
Genova, 16132, Italy
UOSD Allergologia e Immunodeficienze dell'A.O.U. Federico II
Naples, 80131, Italy
Fondazione IRCCS Policlinico "San Matteo" - SC Pneumologia'
Pavia, 27100, Italy
KKR Sapporo Medical Center
Sapporo, Hokkaido, 062-0931, Japan
Oji General Hospital
Tomakomai, Hokkaido, 053-8506, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Kishiwada City Hospital
Kishiwada, Osaka, 596-8501, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Fukuwa Clinics
Chuo-ku, Tokyo, 104-0031, Japan
National Hospital Organization Ibarakihigashi National Hospital
Ibaraki, 319-1113, Japan
Osaka Metropolitan University Hospital
Osaka, 545-0051, Japan
Centrum Badan Klinicznych
Wroclaw, Dolnoslaskie Voivodeship, 51-162, Poland
"ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
Wroclaw, Dolnoslaskie Voivodeship, 53-201, Poland
Lekarze Specjalisci - J. Malolepszy I Partnerzy
Wroclaw, Dolnoslaskie Voivodeship, 54-239, Poland
Centrum Medyczne All-Med Spolka Komandytowa
Krakow, Malopolskie Voivodeship, 30-033, Poland
Nzoz Atopia
Krakow, Malopolskie Voivodeship, 31-159, Poland
Malopolskie Centrum Alergologii
Krakow, Malopolskie Voivodeship, 31-624, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów, Malopolskie Voivodeship, 33-100, Poland
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
Rzeszów, Podkarpackie Voivodeship, 35-051, Poland
EMED Centrum Uslug Medycznych
Rzeszów, Podkarpackie Voivodeship, 35-205, Poland
Centrum Medycyny Oddechowej, Mroz Spolka Jawna
Bialystok, Podlaskie Voivodeship, 15-044, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii
Gdansk, Pomorskie Voivodeship, 80-214, Poland
Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Newtown Clinical Research Centre
Johannesburg, Gauteng, 2001, South Africa
Emmed Research
Pretoria, Gauteng, 0002, South Africa
FCRN Clinical Trial Centre
Vereeniging, Gauteng, 1935, South Africa
St Augustine's Hospital/Dr. IA Abdullah
Durban, KwaZulu-Natal, 4001, South Africa
University of Cape Town Lung Institute
Cape Town, Western Cape, 7700, South Africa
Synapta Clinical Research Centre
Durban, 4001, South Africa
Chungbuk National University Hospital
Cheongju-si, Chubgbuk, 28644, South Korea
Eunpyeong St. Marys Hospital
Seoul, Korea, 03312, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, Republic of Korea, 06591, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Kyung Hee University Hospital
Seoul, 2447, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Yonsei University Health System - Severance Hospital
Seoul, 3722, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Giromed Institute
Girona, Barcelona, 08017, Spain
Hospital Gregorio Marañon
Madrid, 28007, Spain
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58001, Ukraine
Municipal non-Profit Enterprise "lvano-Frankivsk Regional Phthisiology-Pulmonology Center of lvano-Frankivsk regional council
Ivano-Frankivsk, 76018, Ukraine
Medical Centre "Neuromed" of Limited Liability Company "Scan Light"
Vinnytsia, 21050, Ukraine
Hull University Teaching Hospitals NHS Trust
Cottingham, East Yorkshire, HU16 5JQ, United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP, United Kingdom
Ormeau Clinical Trials Ltd
Belfast, Northern Ireland, BT7 2EB, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Asthma/COPD Clinical Research Centre
Glasgow, Scotland, G12 0YN, United Kingdom
St Peter's Hospital
Chertsey, Surrey, KT16 0PZ, United Kingdom
Heartlands Hospital, University Hospitals Birmingham NHS Trust
Birmingham, West Midlands, B9 5SS, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Duckworth Lane Clinical Research Facility
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Justin Salciccioli, MD
Upstream Bio
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2023
First Posted
January 9, 2024
Study Start
February 27, 2024
Primary Completion
December 16, 2025
Study Completion
March 19, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share