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