A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
- Conditions
- Severe Asthma
- Interventions
- Drug: Verekitug (UPB-101)Drug: Placebo
- Registration Number
- NCT06196879
- Lead Sponsor
- Upstream Bio Inc.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 436
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verekitug (UPB-101): 100 mg Q12W / Placebo Verekitug (UPB-101) Participants 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): 100 mg Q12W / Placebo Placebo Participants 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 Verekitug (UPB-101) Participants 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. Placebo Placebo Participants 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. Verekitug (UPB-101): 100 mg Q24W / Placebo Placebo Participants 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. Verekitug (UPB-101): 400 mg Q24W / Placebo Placebo Participants 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 Verekitug (UPB-101) Participants 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.
- Primary Outcome Measures
Name Time Method Annual Asthma Exacerbation Rate (AAER) Baseline up to Week 60 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60 Baseline to Week 60 Spirometry will be performed pre-bronchodilator (BD) to measure lung function. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60 Baseline to Week 60 ACQ-6 is a participant-reported questionnaire to assess asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Up to Week 64 An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60 Baseline to Week 60 Standardized single breath FeNO test is performed to evaluate airway inflammation.
Trial Locations
- Locations (148)
Fundacion Cidea
🇦🇷Caba, Argentina
InAER
🇦🇷Caba, Argentina
Toronto Allergists
🇨🇦Toronto, Ontario, Canada
Winchester Hospital
🇨🇦Winchester, Ontario, Canada
CIMER
🇨🇱Providencia, Chile
Sociedad medica Sy G Limitada
🇨🇱Santiago, Chile
UOSD Allergologia e Immunodeficienze dell'A.O.U. Federico II
🇮🇹Napoli, Italy
Fondazione IRCCS Policlinico "San Matteo" - SC Pneumologia'
🇮🇹Pavia, Italy
KKR Sapporo Medical Center
🇯🇵Sapporo, Hokkaido, Japan
Oji General Hospital
🇯🇵Tomakomai, Hokkaido, Japan
RCMS/Lungenpraxis Hohenzollerndamm
🇩🇪Berlin, Germany
AllerVie Clinical Research
🇺🇸Birmingham, Alabama, United States
Kern Research, Inc.
🇺🇸Bakersfield, California, United States
Velocity Clinical Research - Lafayette LA
🇺🇸Los Angeles, California, United States
Newport Native MD Inc
🇺🇸Newport Beach, California, United States
California Medical Research Associates Inc.
🇺🇸Northridge, California, United States
Integrated Research of Inland Inc
🇺🇸Upland, California, United States
Allergy & Asthma Clinical Research
🇺🇸Walnut Creek, California, United States
Allianz Research Institute
🇺🇸Westminster, California, United States
Woodland Clinic Medical Group
🇺🇸Woodland, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Advance Pharma Research
🇺🇸Cutler Bay, Florida, United States
Unique Clinical Trials
🇺🇸Doral, Florida, United States
Health and Life Research Institute, LLC
🇺🇸Miami, Florida, United States
Phoenix Medical Research
🇺🇸Miami, Florida, United States
Research Institute of South Florida
🇺🇸Miami, Florida, United States
Nouvelle Clinical Research
🇺🇸Miami, Florida, United States
Anderson Allergy And Asthma, PA
🇺🇸Orlando, Florida, United States
Edward Jenner Research Group, LLC
🇺🇸Plantation, Florida, United States
R&B Medical Center
🇺🇸Tampa, Florida, United States
Clinical Site Partners dba Flourish research
🇺🇸Winter Park, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
Pivotal Research Solutions
🇺🇸Stonecrest, Georgia, United States
RNA America Health Sciences
🇺🇸Sugar hill, Georgia, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Velocity Clinical Research - Meridian
🇺🇸Meridian, Idaho, United States
Howard County Center for Lung and Sleep Medicine LLC
🇺🇸Columbia, Maryland, United States
Chesapeake Clinical Research Inc
🇺🇸White Marsh, Maryland, United States
Exordia Medical Research Inc
🇺🇸Fall River, Massachusetts, United States
Pulmonary Research Institute of Southeast Michigan
🇺🇸Farmington Hills, Michigan, United States
AA Medical Research Center
🇺🇸Flint, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
M3 Wake Research
🇺🇸Las Vegas, Nevada, United States
Urban Health Plan INC
🇺🇸Bronx, New York, United States
Advanced Respiratory and Sleep Medicine LLC
🇺🇸Huntersville, North Carolina, United States
Summit Research Group LLC
🇺🇸Munroe Falls, Ohio, United States
Toledo Institute of Clinical Research Inc
🇺🇸Toledo, Ohio, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Velocity Clinical Research - Medford
🇺🇸Medford, Oregon, United States
Velocity Clinical Research - Anderson
🇺🇸Anderson, South Carolina, United States
WR-Notus Clinical Research, LLC
🇺🇸Charleston, South Carolina, United States
Velocity Clinical Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Horizon Clinical Research
🇺🇸Cypress, Texas, United States
Alina Clinical Trials, LLC
🇺🇸Dallas, Texas, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
El Paso Pulmonary Association
🇺🇸El Paso, Texas, United States
Greater Houston Memorial Pulmonary and Sleep
🇺🇸Houston, Texas, United States
Metroplex Pulmonary and Sleep Center Drive
🇺🇸McKinney, Texas, United States
Element Research Group
🇺🇸San Antonio, Texas, United States
DM Clinical Tomball
🇺🇸Tomball, Texas, United States
Velocity Clinical Research
🇺🇸West Jordan, Utah, United States
University of Wisconsin--Madison
🇺🇸Madison, Wisconsin, United States
Centro de Medicina Respiratoria
🇦🇷Concepción Del Uruguay, Entre Rios, Argentina
Fundacion Scherbovsky
🇦🇷Ciudad de Mendoza, Mendoza, Argentina
Fundacion Estudios Clinicos (FECLIN)
🇦🇷Rosario, Santa Fe, Argentina
Instituto Especialidades de la Salud Rosario
🇦🇷Rosario, Santa Fe, Argentina
Office of Hector H. Altieri MD
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
Investigaciones En Patologias Respiratorias
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
CARE: Centro de Alergia y Enfermedades Respiratorias
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Fundacion Respirar - Centro Medico Dra. De Salvo
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio
🇦🇷Córdoba, Argentina
INSARES
🇦🇷Mendoza, Argentina
Centro Medico Dharma
🇦🇷Mendoza, Argentina
MHAT "Rahila Angelova" Pernik
🇧🇬Pernik, Bulgaria
UMHAT Sveti Georgi
🇧🇬Plovdiv, Bulgaria
Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
🇧🇬Ruse, Bulgaria
Medical Center Excelsior
🇧🇬Sofia, Bulgaria
Medical Center HERA EOOD
🇧🇬Sofia, Bulgaria
DCC Convex
🇧🇬Sofia, Bulgaria
Medconsult Pleven
🇧🇬Sofia, Bulgaria
Medical center Pulmovizhyn
🇧🇬Sofia, Bulgaria
Medical Center New Rehabilitation Center EOOD
🇧🇬Stara Zagora, Bulgaria
MC Zdrave 1
🇧🇬Vratsa, Bulgaria
Dynamic Drug Advancement
🇨🇦Ajax, Ontario, Canada
Ottawa Allergy Research Corp
🇨🇦Ottawa, Ontario, Canada
Fundacion Medica San Cristobal
🇨🇱Santiago, Metropolitana, Chile
Icegclinic
🇨🇱Santiago, Region Metropolitana, Chile
Centro Médico BIOREUMA
🇨🇱Concepción, Chile
Fakultni Nemocnice u Sv. Anny v Brne
🇨🇿Brno, Czech Republic, Czechia
Alergologie a imunologie Hofstetr Alois MUDr. s.r.o.
🇨🇿Jihlava, Czech Republic, Czechia
Plicni Stredisko Teplice S.R.O
🇨🇿Teplice, Czech Republic, Czechia
PNEUMOLOGIE VARNSDORF s.r.o.
🇨🇿Varnsdorf, Czech Republic, Czechia
KPPK Studienzentrum
🇩🇪Koblenz, Rheinland-Pfalz, Germany
POIS Sachsen GmbH
🇩🇪Leipzig, Sachsen, Germany
Velocity Clinical Research Germany , Berlin
🇩🇪Berlin, Germany
Pneumologisches Studienzentrum
🇩🇪Berlin, Germany
ME Clinical Respiratory Research Hamburg GmbH
🇩🇪Hamburg, Germany
IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
🇩🇪Hessen, Germany
IKF Pneumologie GmbH & Co. KG
🇩🇪Mainz, Germany
SSD Asma Grave e Malattie Rare del Polmone, AOU San Luigi Gonzaga
🇮🇹Orbassano, Torino, Italy
Ospedale San Martino
🇮🇹Genova, Italy
Yokohama City University Medical Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Osaka Habikino Medical Center
🇯🇵Habikino, Osaka, Japan
Kishiwada City Hospital
🇯🇵Kishiwada, Osaka, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Fukuwa Clinics
🇯🇵Chuo-ku, Tokyo, Japan
National Hospital Organization Ibarakihigashi National Hospital
🇯🇵Ibaraki, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
Chungbuk National University Hospital
🇰🇷Cheongju, Chubgbuk, Korea, Republic of
Eunpyeong St. Marys Hospital
🇰🇷Seoul, Korea, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital
🇰🇷Seoul, Republic of Korea, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System - Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
"ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
🇵🇱Wroclaw, Dolnoslaskie Voivodeship, Poland
Lekarze Specjalisci - J. Malolepszy I Partnerzy
🇵🇱Wroclaw, Dolnoslaskie Voivodeship, Poland
Centrum Badan Klinicznych
🇵🇱Wrocław, Dolnoslaskie Voivodeship, Poland
Nzoz Atopia
🇵🇱Krakow, Malopolskie Voivodeship, Poland
Malopolskie Centrum Alergologii
🇵🇱Krakow, Malopolskie Voivodeship, Poland
Centrum Medyczne All-Med Spolka Komandytowa
🇵🇱Kraków, Malopolskie Voivodeship, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
🇵🇱Tarnow, Malopolskie Voivodeship, Poland
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
🇵🇱Rzeszow, Podkarpackie Voivodeship, Poland
EMED Centrum Uslug Medycznych
🇵🇱Rzeszow, Podkarpackie Voivodeship, Poland
Centrum Medycyny Oddechowej, Mroz Spolka Jawna
🇵🇱Białystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii
🇵🇱Gdańsk, Pomorskie Voivodeship, Poland
Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
🇵🇱Ostrowiec Świętokrzyski, Swietokrzyskie, Poland
Newtown Clinical Research Centre
🇿🇦Johannesburg, Gauteng, South Africa
Emmed Research
🇿🇦Pretoria, Gauteng, South Africa
FCRN Clinical Trial Centre
🇿🇦Vereeniging, Gauteng, South Africa
St Augustine's Hospital/Dr. IA Abdullah
🇿🇦Durban, KwaZulu Natal, South Africa
University of Cape Town Lung Institute
🇿🇦Cape Town, Western Cape, South Africa
Synapta Clinical Research Centre
🇿🇦Durban, South Africa
Giromed Institute
🇪🇸Girona, Barcelona, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hull University Teaching Hospitals NHS Trust
🇬🇧Cottingham, East Yorkshire, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, Merseyside, United Kingdom
Ormeau Clinical Trials Ltd
🇬🇧Belfast, N. Ireland, United Kingdom
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Asthma/COPD Clinical Research Centre
🇬🇧Glasgow, Scotland, United Kingdom
St Peter's Hospital
🇬🇧Chertsey, Surrey, United Kingdom
Heartlands Hospital, University Hospitals Birmingham NHS Trust
🇬🇧Birmingham, West Midlands, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, West Yorkshire, United Kingdom
Duckworth Lane Clinical Research Facility
🇬🇧Bradford, West Yorkshire, United Kingdom