A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

April 30, 2026 updated by: Upstream Bio Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
479

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Upstream Bio Clinical Trials Information (Privacy Notice: https://www.upstreambio.com/privacy)
  • Phone Number: 888-446-3130
  • Email: clinicaltrials@upstreambio.com

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
        • Fundación 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 Spólka 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annual Asthma Exacerbation Rate (AAER)
Time Frame: 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.
Baseline up to Week 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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.
Baseline to Week 60
Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60
Time Frame: Baseline 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
Time Frame: 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.
Baseline to Week 60
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame: 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.
Up to Week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Upstream Bio Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Justin Salciccioli, MD, Upstream Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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