Phase
Condition
Asthma
Treatment
Placebo
Verekitug (UPB-101)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Study Description
Connect with a study center
IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
Centro de Medicina Respiratoria
Concepción Del Uruguay, Entre Rios E3260
ArgentinaSite Not Available
Fundacion Scherbovsky
Ciudad de Mendoza, Mendoza 5500
ArgentinaSite Not Available
Fundacion Estudios Clinicos (FECLIN)
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Instituto Especialidades de la Salud Rosario
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Investigaciones En Patologias Respiratorias
San Miguel De Tucumán, Tucumán CP T4000IAP
ArgentinaSite Not Available
Office of Hector H. Altieri MD
San Miguel De Tucumán, Tucumán 4000
ArgentinaSite Not Available
Fundacion Cidea
Caba, C1121ABE
ArgentinaSite Not Available
InAER
Caba, C1425BEN
ArgentinaSite Not Available
CARE: Centro de Alergia y Enfermedades Respiratorias
Ciudad Autónoma de Buenos Aires, C1414AIF
ArgentinaSite Not Available
Fundacion Respirar - Centro Medico Dra. De Salvo
Ciudad Autónoma de Buenos Aires, C1426ABP
ArgentinaSite Not Available
Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio
Córdoba, X5003DCE
ArgentinaSite Not Available
Centro Medico Dharma
Mendoza, M5500
ArgentinaSite Not Available
INSARES
Mendoza, 5500
ArgentinaSite Not Available
MHAT "Rahila Angelova" Pernik
Pernik, 2300
BulgariaSite Not Available
UMHAT Sveti Georgi
Plovdiv, 4001
BulgariaSite Not Available
Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
Ruse, 7000
BulgariaSite Not Available
DCC Convex
Sofia, 1680
BulgariaSite Not Available
Medconsult Pleven
Sofia, 1756
BulgariaSite Not Available
Medical Center Excelsior
Sofia, 1407
BulgariaSite Not Available
Medical Center HERA EOOD
Sofia, 1510
BulgariaSite Not Available
Medical center Pulmovizhyn
Sofia, 1756
BulgariaSite Not Available
Medical Center New Rehabilitation Center EOOD
Stara Zagora, 6001
BulgariaSite Not Available
MC Zdrave 1
Vratsa, 3320
BulgariaSite Not Available
Dynamic Drug Advancement
Ajax, Ontario L1S 2J5
CanadaSite Not Available
Ottawa Allergy Research Corp
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Toronto Allergists
Toronto, Ontario M5G1E2
CanadaSite Not Available
Winchester Hospital
Winchester, Ontario K0C 2K0
CanadaSite Not Available
Fundacion Medica San Cristobal
Santiago, Metropolitana 7630226
ChileSite Not Available
Icegclinic
Santiago, Region Metropolitana 8241479
ChileSite Not Available
Centro Médico BIOREUMA
Concepción, 4070280
ChileSite Not Available
CIMER
Providencia, 7500657
ChileSite Not Available
Sociedad medica Sy G Limitada
Santiago, 7501126
ChileSite Not Available
Fakultni Nemocnice u Sv. Anny v Brne
Brno, Czech Republic 602 00
CzechiaSite Not Available
Alergologie a imunologie Hofstetr Alois MUDr. s.r.o.
Jihlava, Czech Republic 586 01
CzechiaSite Not Available
Plicni Stredisko Teplice S.R.O
Teplice, Czech Republic 415 01
CzechiaSite Not Available
PNEUMOLOGIE VARNSDORF s.r.o.
Varnsdorf, Czech Republic 407 47
CzechiaSite Not Available
KPPK Studienzentrum
Koblenz, Rheinland-Pfalz 56068
GermanySite Not Available
POIS Sachsen GmbH
Leipzig, Sachsen 04347
GermanySite Not Available
Pneumologisches Studienzentrum
Berlin, 10961
GermanySite Not Available
RCMS Dr. Linnhoff
Berlin, 10717
GermanyActive - Recruiting
RCMS/Lungenpraxis Hohenzollerndamm
Berlin, 10717
GermanySite Not Available
Velocity Clinical Research Germany , Berlin
Berlin, 10787
GermanySite Not Available
ME Clinical Respiratory Research Hamburg GmbH
Hamburg, 22299
GermanySite Not Available
IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
Hessen, 60596
GermanySite Not Available
IKF Pneumologie GmbH & Co. KG
Mainz, 55128
GermanySite Not Available
SSD Asma Grave e Malattie Rare del Polmone, AOU San Luigi Gonzaga
Orbassano, Torino 10043
ItalySite Not Available
Ospedale San Martino
Genova, 16132
ItalySite Not Available
UOSD Allergologia e Immunodeficienze dell'A.O.U. Federico II
Napoli, 80131
ItalySite Not Available
Fondazione IRCCS Policlinico "San Matteo" - SC Pneumologia'
Pavia, 27100
ItalySite Not Available
KKR Sapporo Medical Center
Sapporo, Hokkaido 062-0931
JapanSite Not Available
Oji General Hospital
Tomakomai, Hokkaido 053-8506
JapanSite Not Available
Yokohama City University Medical Center
Yokohama-shi, Kanagawa 232-0024
JapanSite Not Available
Osaka Habikino Medical Center
Habikino, Osaka 583-8588
JapanSite Not Available
Kishiwada City Hospital
Kishiwada, Osaka 596-8501
JapanSite Not Available
Fukuwa Clinics
Chuo-ku, Tokyo 104-0031
JapanSite Not Available
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo 103-0027
JapanSite Not Available
National Hospital Organization Ibarakihigashi National Hospital
Ibaraki, 319-1113
JapanSite Not Available
Osaka Metropolitan University Hospital
Osaka, 545-0051
JapanSite Not Available
Chungbuk National University Hospital
Cheongju, Chubgbuk 28644
Korea, Republic ofSite Not Available
Eunpyeong St. Marys Hospital
Seoul, Korea 03312
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, Republic of Korea 06591
Korea, Republic ofSite Not Available
Soonchunhyang University Bucheon Hospital
Bucheon, 14584
Korea, Republic ofSite Not Available
Yeungnam University Hospital
Daegu, 42415
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Kyung Hee University Hospital
Seoul, 2447
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 6351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 3080
Korea, Republic ofSite Not Available
Yonsei University Health System - Severance Hospital
Seoul, 3722
Korea, Republic ofSite Not Available
"ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
Wroclaw, Dolnoslaskie Voivodeship 53-201
PolandSite Not Available
Lekarze Specjalisci - J. Malolepszy I Partnerzy
Wroclaw, Dolnoslaskie Voivodeship 54-239
PolandSite Not Available
Centrum Badan Klinicznych
Wrocław, Dolnoslaskie Voivodeship 51-162
PolandSite Not Available
Malopolskie Centrum Alergologii
Krakow, Malopolskie Voivodeship 31-624
PolandSite Not Available
Nzoz Atopia
Krakow, Malopolskie Voivodeship 31-159
PolandSite Not Available
Centrum Medyczne All-Med Spolka Komandytowa
Kraków, Malopolskie Voivodeship 30-033
PolandSite Not Available
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnow, Malopolskie Voivodeship 33-100
PolandSite Not Available
EMED Centrum Uslug Medycznych
Rzeszow, Podkarpackie Voivodeship 35-205
PolandSite Not Available
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
Rzeszow, Podkarpackie Voivodeship 35-051
PolandSite Not Available
Centrum Medycyny Oddechowej, Mroz Spolka Jawna
Białystok, Podlaskie Voivodeship 15-044
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii
Gdańsk, Pomorskie Voivodeship 80-214
PolandSite Not Available
Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Swietokrzyskie 27-400
PolandSite Not Available
Newtown Clinical Research Centre
Johannesburg, Gauteng 2001
South AfricaSite Not Available
Emmed Research
Pretoria, Gauteng 0002
South AfricaSite Not Available
FCRN Clinical Trial Centre
Vereeniging, Gauteng 1935
South AfricaSite Not Available
St Augustine's Hospital/Dr. IA Abdullah
Durban, KwaZulu Natal 4001
South AfricaSite Not Available
University of Cape Town Lung Institute
Cape Town, Western Cape 7700
South AfricaSite Not Available
Synapta Clinical Research Centre
Durban, 4001
South AfricaSite Not Available
Giromed Institute
Girona, Barcelona 08017
SpainSite Not Available
Hospital Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58001
UkraineSite Not Available
Municipal non-Profit Enterprise "lvano-Frankivsk Regional Phthisiology-Pulmonology Center of lvano-Frankivsk regional council
Ivano-Frankivs'k, 76018
UkraineSite Not Available
Medical Centre "Neuromed" of Limited Liability Company "Scan Light"
Vinnytsia, 21050
UkraineSite Not Available
Hull University Teaching Hospitals NHS Trust
Cottingham, East Yorkshire HU16 5JQ
United KingdomSite Not Available
Royal Liverpool University Hospital
Liverpool, Merseyside L7 8XP
United KingdomSite Not Available
Ormeau Clinical Trials Ltd
Belfast, N. Ireland BT7 2EB
United KingdomSite Not Available
Churchill Hospital
Oxford, Oxfordshire OX3 7LE
United KingdomSite Not Available
Asthma/COPD Clinical Research Centre
Glasgow, Scotland G12 0YN
United KingdomSite Not Available
St Peter's Hospital
Chertsey, Surrey KT16 0PZ
United KingdomSite Not Available
Perth Royal Infirmary
Perth, Tayside PH1 1NX
United KingdomSite Not Available
Heartlands Hospital, University Hospitals Birmingham NHS Trust
Birmingham, West Midlands B9 5SS
United KingdomSite Not Available
Bradford Royal Infirmary
Bradford, West Yorkshire BD9 6RJ
United KingdomSite Not Available
Duckworth Lane Clinical Research Facility
Bradford, West Yorkshire BD9 6RJ
United KingdomSite Not Available
AllerVie Clinical Research
Birmingham, Alabama 35209
United StatesSite Not Available
Kern Research, Inc.
Bakersfield, California 93301
United StatesSite Not Available
Velocity Clinical Research - Lafayette LA
Los Angeles, California 70508
United StatesSite Not Available
Newport Native MD Inc
Newport Beach, California 92663
United StatesSite Not Available
California Medical Research Associates Inc.
Northridge, California 91324
United StatesSite Not Available
Integrated Research of Inland Inc
Upland, California 91786
United StatesSite Not Available
Allergy & Asthma Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
Allianz Research Institute
Westminster, California 92683
United StatesSite Not Available
Woodland Clinic Medical Group
Woodland, California 95695
United StatesSite Not Available
National Jewish Health
Denver, Colorado 80206
United StatesSite Not Available
Advance Pharma Research
Cutler Bay, Florida 33189
United StatesSite Not Available
Unique Clinical Trials
Doral, Florida 33172
United StatesSite Not Available
Clinical Site Partners
Miami, Florida 33176
United StatesActive - Recruiting
Clinical Site Partners, LLC dba Flourish Research
Miami, Florida 33176
United StatesActive - Recruiting
Health and Life Research Institute, LLC
Miami, Florida 33155
United StatesSite Not Available
Nouvelle Clinical Research
Miami, Florida 33189
United StatesSite Not Available
Phoenix Medical Research
Miami, Florida 33165
United StatesSite Not Available
Research Institute of South Florida
Miami, Florida 33173
United StatesSite Not Available
Anderson Allergy And Asthma, PA
Orlando, Florida 32806
United StatesSite Not Available
Edward Jenner Research Group, LLC
Plantation, Florida 33317
United StatesSite Not Available
R&B Medical Center
Tampa, Florida 33614
United StatesSite Not Available
Clinical Site Partners dba Flourish research
Winter Park, Florida 32789
United StatesSite Not Available
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida 32789
United StatesSite Not Available
Pivotal Research Solutions
Stonecrest, Georgia 30038
United StatesSite Not Available
RNA America Health Sciences
Sugar hill, Georgia 30518
United StatesSite Not Available
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesSite Not Available
Velocity Clinical Research - Meridian
Meridian, Idaho 83642
United StatesSite Not Available
Howard County Center for Lung and Sleep Medicine LLC
Columbia, Maryland 21044
United StatesSite Not Available
Chesapeake Clinical Research Inc
White Marsh, Maryland 21162
United StatesSite Not Available
Exordia Medical Research Inc
Fall River, Massachusetts 02723
United StatesSite Not Available
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan 48336
United StatesSite Not Available
AA MRC
Flint, Michigan 48504
United StatesActive - Recruiting
AA Medical Research Center
Flint, Michigan 48504
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
M3 Wake Research
Las Vegas, Nevada 89106
United StatesSite Not Available
Urban Health Plan INC
Bronx, New York 10459
United StatesSite Not Available
Advanced Respiratory and Sleep Medicine LLC
Huntersville, North Carolina 28078
United StatesSite Not Available
Summit Research Group LLC
Munroe Falls, Ohio 44262
United StatesSite Not Available
Toledo Institute of Clinical Research Inc
Toledo, Ohio 43617
United StatesSite Not Available
OK Clinical Research, LLC
Edmond, Oklahoma 73034
United StatesSite Not Available
Portland Clinical Research
Clackamas, Oregon 97015
United StatesSite Not Available
Velocity Clinical Research - Medford
Medford, Oregon 97504
United StatesSite Not Available
Velocity Clinical Research - Anderson
Anderson, South Carolina 29621
United StatesSite Not Available
WR-Notus Clinical Research, LLC
Charleston, South Carolina 29414
United StatesSite Not Available
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina 29303
United StatesSite Not Available
WR-ClinSearch, LLC
Chattanooga, Tennessee 37421
United StatesSite Not Available
Horizon Clinical Research
Cypress, Texas 77429
United StatesSite Not Available
AARA Research Center
Dallas, Texas 75231
United StatesSite Not Available
Alina Clinical Trials, LLC
Dallas, Texas 75225
United StatesSite Not Available
El Paso Pulmonary Association
El Paso, Texas 79902
United StatesSite Not Available
Greater Houston Memorial Pulmonary and Sleep
Houston, Texas 77008
United StatesSite Not Available
Sante Clinical Research
Kerrville, Texas 78028
United StatesSite Not Available
Mayflower Clinical
Marble Falls, Texas 02747
United StatesSite Not Available
Metroplex Pulmonary and Sleep Center Drive
McKinney, Texas 75069
United StatesSite Not Available
Element Research Group
San Antonio, Texas 78258
United StatesSite Not Available
DM Clinical Tomball
Tomball, Texas 77375
United StatesSite Not Available
Velocity Clinical Research
West Jordan, Utah 84088
United StatesSite Not Available
University of Wisconsin--Madison
Madison, Wisconsin 53792
United StatesSite Not Available
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