Clinical trial NCT06196879: A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Severe Asthma
Keywords: VALIANT
Respiratory Tract Diseases
Bronchial Diseases
Asthma
Lung Diseases
Uncontrolled Asthma
Severe Asthma
Lead sponsor: Upstream Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-09
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Annual Asthma Exacerbation Rate (AAER)
timeFrame: Baseline up to Week 60
Secondary outcomes:
measure: Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60
timeFrame: Baseline to Week 60
measure: Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60
timeFrame: Baseline to Week 60
measure: Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60
timeFrame: Baseline to Week 60
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Up to Week 64
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AllerVie Clinical Research
state: Alabama
city: Bakersfield
country: United States
facility: Kern Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Lafayette LA
state: California
city: Newport Beach
country: United States
facility: Newport Native MD Inc
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc.
state: California
city: Upland
country: United States
facility: Integrated Research of Inland Inc
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research
state: California
city: Westminster
country: United States
facility: Allianz Research Institute
state: California
city: Woodland
country: United States
facility: Woodland Clinic Medical Group
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Cutler Bay
country: United States
facility: Advance Pharma Research
state: Florida
city: Doral
country: United States
facility: Unique Clinical Trials
state: Florida
city: Miami
country: United States
facility: Health and Life Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Phoenix Medical Research
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Miami
country: United States
facility: Nouvelle Clinical Research
state: Florida
city: Orlando
country: United States
facility: Anderson Allergy And Asthma, PA
state: Florida
city: Plantation
country: United States
facility: Edward Jenner Research Group, LLC
state: Florida
city: Tampa
country: United States
facility: R&B Medical Center
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners dba Flourish research
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Stonecrest
country: United States
facility: Pivotal Research Solutions
state: Georgia
city: Sugar hill
country: United States
facility: RNA America Health Sciences
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research - Meridian
state: Idaho
city: Columbia
country: United States
facility: Howard County Center for Lung and Sleep Medicine LLC
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research Inc
state: Maryland
city: Fall River
country: United States
facility: Exordia Medical Research Inc
state: Massachusetts
city: Farmington Hills
country: United States
facility: Pulmonary Research Institute of Southeast Michigan
state: Michigan
city: Flint
country: United States
facility: AA Medical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: M3 Wake Research
state: Nevada
city: Bronx
country: United States
facility: Urban Health Plan INC
state: New York
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine LLC
state: North Carolina
city: Munroe Falls
country: United States
facility: Summit Research Group LLC
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research Inc
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Clackamas
country: United States
facility: Portland Clinical Research
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: Anderson
country: United States
facility: Velocity Clinical Research - Anderson
state: South Carolina
city: Charleston
country: United States
facility: WR-Notus Clinical Research, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research - Spartanburg
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Cypress
country: United States
facility: Horizon Clinical Research
state: Texas
city: Dallas
country: United States
facility: Alina Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: El Paso
country: United States
facility: El Paso Pulmonary Association
state: Texas
city: Houston
country: United States
facility: Greater Houston Memorial Pulmonary and Sleep
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: Marble Falls
country: United States
facility: Mayflower Clinical
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center Drive
state: Texas
city: San Antonio
country: United States
facility: Element Research Group
state: Texas
city: Tomball
country: United States
facility: DM Clinical Tomball
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research
state: Utah
city: Madison
country: United States
facility: University of Wisconsin--Madison
state: Wisconsin
city: Florencio Varela
country: Argentina
facility: IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
state: Buenos Aires
city: Concepción Del Uruguay
country: Argentina
facility: Centro de Medicina Respiratoria
state: Entre Rios
city: Ciudad de Mendoza
country: Argentina
facility: Fundacion Scherbovsky
state: Mendoza
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos (FECLIN)
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Especialidades de la Salud Rosario
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Office of Hector H. Altieri MD
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Investigaciones En Patologias Respiratorias
state: Tucumán
city: Caba
country: Argentina
facility: Fundacion Cidea
city: Caba
country: Argentina
facility: InAER
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CARE: Centro de Alergia y Enfermedades Respiratorias
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundacion Respirar - Centro Medico Dra. De Salvo
city: Córdoba
country: Argentina
facility: Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio
city: Mendoza
country: Argentina
facility: INSARES
city: Mendoza
country: Argentina
facility: Centro Medico Dharma
city: Pernik
country: Bulgaria
facility: MHAT "Rahila Angelova" Pernik
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Ruse
country: Bulgaria
facility: Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior
city: Sofia
country: Bulgaria
facility: Medical Center HERA EOOD
city: Sofia
country: Bulgaria
facility: DCC Convex
city: Sofia
country: Bulgaria
facility: Medconsult Pleven
city: Sofia
country: Bulgaria
facility: Medical center Pulmovizhyn
city: Stara Zagora
country: Bulgaria
facility: Medical Center New Rehabilitation Center EOOD
city: Vratsa
country: Bulgaria
facility: MC Zdrave 1
city: Ajax
country: Canada
facility: Dynamic Drug Advancement
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Toronto Allergists
state: Ontario
city: Winchester
country: Canada
facility: Winchester Hospital
state: Ontario
city: Santiago
country: Chile
facility: Fundacion Medica San Cristobal
state: Metropolitana
city: Santiago
country: Chile
facility: Icegclinic
state: Region Metropolitana
city: Concepción
country: Chile
facility: Centro Médico BIOREUMA
city: Providencia
country: Chile
facility: CIMER
city: Santiago
country: Chile
facility: Sociedad medica Sy G Limitada
city: Brno
country: Czechia
facility: Fakultni Nemocnice u Sv. Anny v Brne
state: Czech Republic
city: Jihlava
country: Czechia
facility: Alergologie a imunologie Hofstetr Alois MUDr. s.r.o.
state: Czech Republic
city: Teplice
country: Czechia
facility: Plicni Stredisko Teplice S.R.O
state: Czech Republic
city: Varnsdorf
country: Czechia
facility: PNEUMOLOGIE VARNSDORF s.r.o.
state: Czech Republic
city: Koblenz
country: Germany
facility: KPPK Studienzentrum
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: POIS Sachsen GmbH
state: Sachsen
city: Berlin
country: Germany
facility: RCMS/Lungenpraxis Hohenzollerndamm
city: Berlin
country: Germany
facility: Velocity Clinical Research Germany , Berlin
city: Berlin
country: Germany
facility: Pneumologisches Studienzentrum
city: Hamburg
country: Germany
facility: ME Clinical Respiratory Research Hamburg GmbH
city: Hessen
country: Germany
facility: IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
city: Mainz
country: Germany
facility: IKF Pneumologie GmbH & Co. KG
city: Orbassano
country: Italy
facility: SSD Asma Grave e Malattie Rare del Polmone, AOU San Luigi Gonzaga
state: Torino
city: Genova
country: Italy
facility: Ospedale San Martino
city: Napoli
country: Italy
facility: UOSD Allergologia e Immunodeficienze dell'A.O.U. Federico II
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico "San Matteo" - SC Pneumologia'
city: Sapporo
country: Japan
facility: KKR Sapporo Medical Center
state: Hokkaido
city: Tomakomai
country: Japan
facility: Oji General Hospital
state: Hokkaido
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinics
state: Tokyo
city: Ibaraki
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chubgbuk
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Marys Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital
state: Republic of Korea
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System - Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wroclaw
country: Poland
facility: "ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
state: Dolnoslaskie Voivodeship
city: Wroclaw
country: Poland
facility: Lekarze Specjalisci - J. Malolepszy I Partnerzy
state: Dolnoslaskie Voivodeship
city: Wrocław
country: Poland
facility: Centrum Badan Klinicznych
state: Dolnoslaskie Voivodeship
city: Krakow
country: Poland
facility: Nzoz Atopia
state: Malopolskie Voivodeship
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
state: Malopolskie Voivodeship
city: Kraków
country: Poland
facility: Centrum Medyczne All-Med Spolka Komandytowa
state: Malopolskie Voivodeship
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
state: Malopolskie Voivodeship
city: Rzeszow
country: Poland
facility: Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
state: Podkarpackie Voivodeship
city: Rzeszow
country: Poland
facility: EMED Centrum Uslug Medycznych
state: Podkarpackie Voivodeship
city: Białystok
country: Poland
facility: Centrum Medycyny Oddechowej, Mroz Spolka Jawna
state: Podlaskie Voivodeship
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii
state: Pomorskie Voivodeship
city: Ostrowiec Świętokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
state: Swietokrzyskie
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre
state: Gauteng
city: Durban
country: South Africa
facility: St Augustine's Hospital/Dr. IA Abdullah
state: KwaZulu Natal
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
state: Western Cape
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
city: Girona
country: Spain
facility: Giromed Institute
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Municipal non-Profit Enterprise "lvano-Frankivsk Regional Phthisiology-Pulmonology Center of lvano-Frankivsk regional council
city: Vinnytsia
country: Ukraine
facility: Medical Centre "Neuromed" of Limited Liability Company "Scan Light"
city: Cottingham
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: East Yorkshire
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: Merseyside
city: Belfast
country: United Kingdom
facility: Ormeau Clinical Trials Ltd
state: N. Ireland
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Glasgow
country: United Kingdom
facility: Asthma/COPD Clinical Research Centre
state: Scotland
city: Chertsey
country: United Kingdom
facility: St Peter's Hospital
state: Surrey
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital, University Hospitals Birmingham NHS Trust
state: West Midlands
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: West Yorkshire
city: Bradford
country: United Kingdom
facility: Duckworth Lane Clinical Research Facility
state: West Yorkshire
Study officials:
affiliation: Upstream Bio
name: James C Lee, MD
role: STUDY_DIRECTOR
References: