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)

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.

Study Overview

• Status: Completed
• Conditions: Severe Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Verekitug (UPB-101)

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).

• Study Type: Interventional
• Enrollment (Actual): 479
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verekitug (UPB-101): 100 mg Q12W / 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.	Drug: Placebo; Verekitug (UPB-101) matching placebo; Drug: Verekitug (UPB-101); Verekitug (UPB-101) formulated solution
Experimental: Verekitug (UPB-101): 400 mg Q24W / 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.	Drug: Placebo; Verekitug (UPB-101) matching placebo; Drug: Verekitug (UPB-101); Verekitug (UPB-101) formulated solution
Experimental: Verekitug (UPB-101): 100 mg Q24W / 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.	Drug: Placebo; Verekitug (UPB-101) matching placebo; Drug: Verekitug (UPB-101); Verekitug (UPB-101) formulated solution
Placebo Comparator: 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.	Drug: Placebo; Verekitug (UPB-101) matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) 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.	Baseline to Week 60
Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60	Standardized single breath FeNO test is performed to evaluate airway inflammation.	Baseline to Week 60
Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) 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.	Baseline to Week 60
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	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.	Up to Week 64

Collaborators and Investigators

• Sponsor: Upstream Bio Inc.
• Investigators: Study Director: Justin Salciccioli, MD, Upstream Bio

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): December 16, 2025
• Study Completion (Actual): March 19, 2026

Study Registration Dates

• First Submitted: December 24, 2023
• First Submitted That Met QC Criteria: December 24, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Severe Asthma; Uncontrolled Asthma; VALIANT
• Additional Relevant MeSH Terms: Immune System Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases; Asthma; Respiratory Tract Diseases; Bronchial Diseases
• Other Study ID Numbers: UPB-CP-04; 2023-507410-27-00 (Other Identifier: EUCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No