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Severe AsthmaPhase 2NCT06196879

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

A Phase 2 study testing Verekitug (UPB-101) in people with Severe Asthma, run by Upstream Bio Inc. at 155 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Severe Asthma
What is being tested?
Verekitug (UPB-101)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
479 participants
Where
155 sitesin 15 countries
Study dates
27 Feb 2024to 19 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

155 sites in 15 countries.

155 sites in 15 countries

United States55 sites

  • Velocity Clinical Research - Anderson

    Anderson, South Carolina, 29621

  • Kern Research, Inc.

    Bakersfield, California, 93301

  • AllerVie Clinical Research

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • WR-Notus Clinical Research, LLC

    Charleston, South Carolina, 29414

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Portland Clinical Research

    Clackamas, Oregon, 97015

  • Howard County Center for Lung and Sleep Medicine LLC

    Columbia, Maryland, 21044

  • Advance Pharma Research

    Cutler Bay, Florida, 33189

  • Horizon Clinical Research

    Cypress, Texas, 77429

  • Alina Clinical Trials, LLC

    Dallas, Texas, 75225

  • AARA Research Center

    Dallas, Texas, 75231

  • National Jewish Health

    Denver, Colorado, 80206

  • Unique Clinical Trials

    Doral, Florida, 33172

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

  • Exordia Medical Research Inc

    Fall River, Massachusetts, 02723

  • Pulmonary Research Institute of Southeast Michigan

    Farmington Hills, Michigan, 48336

  • AA Medical Research Center

    Flint, Michigan, 48504

  • Greater Houston Memorial Pulmonary and Sleep

    Houston, Texas, 77008

  • Advanced Respiratory and Sleep Medicine LLC

    Huntersville, North Carolina, 28078

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • M3 Wake Research

    Las Vegas, Nevada, 89106

  • Velocity Clinical Research - Lafayette LA

    Los Angeles, California, 70508

  • University of Wisconsin--Madison

    Madison, Wisconsin, 53792

  • Mayflower Clinical

    Marble Falls, Texas, 02747

  • Metroplex Pulmonary and Sleep Center Drive

    McKinney, Texas, 75069

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • Velocity Clinical Research - Meridian

    Meridian, Idaho, 83642

  • Health and Life Research Institute, LLC

    Miami, Florida, 33155

  • Phoenix Medical Research

    Miami, Florida, 33165

  • Research Institute of South Florida

    Miami, Florida, 33173

  • Nouvelle Clinical Research

    Miami, Florida, 33189

  • Summit Research Group LLC

    Munroe Falls, Ohio, 44262

  • Newport Native MD Inc

    Newport Beach, California, 92663

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Anderson Allergy And Asthma, PA

    Orlando, Florida, 32806

  • Edward Jenner Research Group, LLC

    Plantation, Florida, 33317

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Element Research Group

    San Antonio, Texas, 78258

  • Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29303

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038

  • RNA America Health Sciences

    Sugar Hill, Georgia, 30518

  • R&B Medical Center

    Tampa, Florida, 33614

  • Urban Health Plan INC

    The Bronx, New York, 10459

  • Toledo Institute of Clinical Research Inc

    Toledo, Ohio, 43617

  • DM Clinical Tomball

    Tomball, Texas, 77375

  • Integrated Research of Inland Inc

    Upland, California, 91786

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598

  • Velocity Clinical Research

    West Jordan, Utah, 84088

  • Allianz Research Institute

    Westminster, California, 92683

  • Chesapeake Clinical Research Inc

    White Marsh, Maryland, 21162

  • Clinical Site Partners dba Flourish research

    Winter Park, Florida, 32789

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789

  • Woodland Clinic Medical Group

    Woodland, California, 95695

Other trials in United States

Argentina14 sites

  • CARE: Centro de Alergia y Enfermedades Respiratorias

    Buenos Aires, C1414AIF

  • Fundacion Respirar - Centro Medico Dra. De Salvo

    Buenos Aires, C1426ABP

  • Fundacion Cidea

    Caba, C1121ABE

  • InAER

    CABA, C1425BEN

  • Centro de Medicina Respiratoria

    Concepción del Uruguay, Entre Ríos Province, E3260

  • Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio

    Córdoba, X5003DCE

  • Fundacion Scherbovsky

    Mendoza, Mendoza Province, 5500

  • INSARES

    Mendoza, 5500

  • Centro Medico Dharma

    Mendoza, M5500

  • Fundacion Estudios Clinicos (FECLIN)

    Rosario, Santa Fe Province, 2000

  • Instituto Especialidades de la Salud Rosario

    Rosario, Santa Fe Province, 2000

  • IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica

    San Juan Bautista, Buenos Aires, 1888

  • Office of Hector H. Altieri MD

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigaciones En Patologias Respiratorias

    San Miguel de Tucumán, Tucumán Province, CP T4000IAP

Other trials in Argentina

Poland12 sites

  • Centrum Medycyny Oddechowej, Mroz Spolka Jawna

    Bialystok, Podlaskie Voivodeship, 15-044

  • Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii

    Gdansk, Pomorskie Voivodeship, 80-214

  • Centrum Medyczne All-Med Spolka Komandytowa

    Krakow, Malopolskie Voivodeship, 30-033

  • Nzoz Atopia

    Krakow, Malopolskie Voivodeship, 31-159

  • Malopolskie Centrum Alergologii

    Krakow, Malopolskie Voivodeship, 31-624

  • Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

    Rzeszów, Podkarpackie Voivodeship, 35-051

  • EMED Centrum Uslug Medycznych

    Rzeszów, Podkarpackie Voivodeship, 35-205

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

    Tarnów, Malopolskie Voivodeship, 33-100

  • Centrum Badan Klinicznych

    Wroclaw, Dolnoslaskie Voivodeship, 51-162

  • "ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

    Wroclaw, Dolnoslaskie Voivodeship, 53-201

  • Lekarze Specjalisci - J. Malolepszy I Partnerzy

    Wroclaw, Dolnoslaskie Voivodeship, 54-239

Other trials in Poland

Bulgaria10 sites

  • MHAT "Rahila Angelova" Pernik

    Pernik, 2300

  • UMHAT Sveti Georgi

    Plovdiv, 4001

  • Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd

    Rousse, 7000

  • Medical Center Excelsior

    Sofia, 1407

  • Medical Center HERA EOOD

    Sofia, 1510

  • DCC Convex

    Sofia, 1680

  • Medconsult Pleven

    Sofia, 1756

  • Medical center Pulmovizhyn

    Sofia, 1756

  • Medical Center New Rehabilitation Center EOOD

    Stara Zagora, 6001

  • MC Zdrave 1

    Vratsa, 3320

Other trials in Bulgaria

South Korea10 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, 14584

  • Chungbuk National University Hospital

    Cheongju-si, Chubgbuk, 28644

  • Yeungnam University Hospital

    Daegu, 42415

  • Eunpyeong St. Marys Hospital

    Seoul, Korea, 03312

  • The Catholic University of Korea, Seoul St. Marys Hospital

    Seoul, Republic of Korea, 06591

  • Asan Medical Center

    Seoul, 05505

  • Kyung Hee University Hospital

    Seoul, 2447

  • Seoul National University Hospital

    Seoul, 3080

  • Yonsei University Health System - Severance Hospital

    Seoul, 3722

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

Japan9 sites

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinics

    Chuo-ku, Tokyo, 104-0031

  • Osaka Habikino Medical Center

    Habikino, Osaka, 583-8588

  • National Hospital Organization Ibarakihigashi National Hospital

    Ibaraki, 319-1113

  • Kishiwada City Hospital

    Kishiwada, Osaka, 596-8501

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051

  • KKR Sapporo Medical Center

    Sapporo, Hokkaido, 062-0931

  • Oji General Hospital

    Tomakomai, Hokkaido, 053-8506

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

United Kingdom9 sites

  • Ormeau Clinical Trials Ltd

    Belfast, Northern Ireland, BT7 2EB

  • Heartlands Hospital, University Hospitals Birmingham NHS Trust

    Birmingham, West Midlands, B9 5SS

  • Bradford Royal Infirmary

    Bradford, West Yorkshire, BD9 6RJ

  • Duckworth Lane Clinical Research Facility

    Bradford, West Yorkshire, BD9 6RJ

  • St Peter's Hospital

    Chertsey, Surrey, KT16 0PZ

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, East Yorkshire, HU16 5JQ

  • Asthma/COPD Clinical Research Centre

    Glasgow, Scotland, G12 0YN

  • Royal Liverpool University Hospital

    Liverpool, Merseyside, L7 8XP

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

Germany8 sites

  • RCMS/Lungenpraxis Hohenzollerndamm

    Berlin, 10717

  • Velocity Clinical Research Germany , Berlin

    Berlin, 10787

  • Pneumologisches Studienzentrum

    Berlin, 10961

  • ME Clinical Respiratory Research Hamburg GmbH

    Hamburg, 22299

  • IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

    Hessen, 60596

  • KPPK Studienzentrum

    Koblenz, Rhineland-Palatinate, 56068

  • POIS Sachsen GmbH

    Leipzig, Saxony, 04347

  • IKF Pneumologie GmbH & Co. KG

    Mainz, 55128

Other trials in Germany

South Africa6 sites

  • University of Cape Town Lung Institute

    Cape Town, Western Cape, 7700

  • St Augustine's Hospital/Dr. IA Abdullah

    Durban, KwaZulu-Natal, 4001

  • Synapta Clinical Research Centre

    Durban, 4001

  • Newtown Clinical Research Centre

    Johannesburg, Gauteng, 2001

  • Emmed Research

    Pretoria, Gauteng, 0002

  • FCRN Clinical Trial Centre

    Vereeniging, Gauteng, 1935

Other trials in South Africa

Chile5 sites

  • Centro Médico BIOREUMA

    Concepción, 4070280

  • CIMER

    Providencia, 7500657

  • Fundacion Medica San Cristobal

    Santiago, Santiago Metropolitan, 7630226

  • Icegclinic

    Santiago, Santiago Metropolitan, 8241479

  • Sociedad medica Sy G Limitada

    Santiago, 7501126

Other trials in Chile

Canada4 sites

  • Dynamic Drug Advancement

    Ajax, Ontario, L1S 2J5

  • Ottawa Allergy Research Corp

    Ottawa, Ontario, K1H 1E4

  • Toronto Allergists

    Toronto, Ontario, M5G1E2

  • Winchester Hospital

    Winchester, Ontario, K0C 2K0

Other trials in Canada

Czechia4 sites

  • Fakultni Nemocnice u Sv. Anny v Brne

    Brno, Czech Republic, 602 00

  • Alergologie a imunologie Hofstetr Alois MUDr. s.r.o.

    Jihlava, Czech Republic, 586 01

  • Plicni Stredisko Teplice S.R.O

    Teplice, Czech Republic, 415 01

  • PNEUMOLOGIE VARNSDORF s.r.o.

    Varnsdorf, Czech Republic, 407 47

Other trials in Czechia

Italy4 sites

  • Ospedale San Martino

    Genova, 16132

  • UOSD Allergologia e Immunodeficienze dell'A.O.U. Federico II

    Naples, 80131

  • SSD Asma Grave e Malattie Rare del Polmone, AOU San Luigi Gonzaga

    Orbassano, Torino, 10043

  • Fondazione IRCCS Policlinico "San Matteo" - SC Pneumologia'

    Pavia, 27100

Other trials in Italy

Ukraine3 sites

  • Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58001

  • Municipal non-Profit Enterprise "lvano-Frankivsk Regional Phthisiology-Pulmonology Center of lvano-Frankivsk regional council

    Ivano-Frankivsk, 76018

  • Medical Centre "Neuromed" of Limited Liability Company "Scan Light"

    Vinnytsia, 21050

Other trials in Ukraine

Spain2 sites

  • Giromed Institute

    Girona, Barcelona, 08017

  • Hospital Gregorio Marañon

    Madrid, 28007

Other trials in Spain

About this study

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)

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.

Read the 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).

Conditions
Severe Asthma
Being tested
Verekitug (UPB-101), Placebo
Keywords
VALIANT, Respiratory Tract Diseases, Bronchial Diseases, Asthma, Lung Diseases, Uncontrolled Asthma, Severe Asthma
Medical subject headings
Asthma, Respiratory Tract Diseases, Bronchial Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Verekitug (UPB-101)Drug

    Verekitug (UPB-101) formulated solution

  • PlaceboDrug

    Verekitug (UPB-101) matching placebo

Study groups in NCT06196879
Study groupRoleWhat they receive
Verekitug (UPB-101): 100 mg Q12W / PlaceboExperimentalParticipants 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.
Receives: Drug: Verekitug (UPB-101); Drug: Placebo
Verekitug (UPB-101): 400 mg Q24W / PlaceboExperimentalParticipants 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.
Receives: Drug: Verekitug (UPB-101); Drug: Placebo
Verekitug (UPB-101): 100 mg Q24W / PlaceboExperimentalParticipants 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.
Receives: Drug: Verekitug (UPB-101); Drug: Placebo
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to Week 60

Secondary outcomes (4)

  1. 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.

    Measured: Baseline to Week 60

  2. Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60

    Standardized single breath FeNO test is performed to evaluate airway inflammation.

    Measured: Baseline to Week 60

  3. 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.

    Measured: Baseline to Week 60

  4. 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.

    Measured: Up to Week 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start27 Feb 2024
  3. Primary completion16 Dec 2025
  4. Study completion19 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196879
Sponsor's protocol ID
UPB-CP-04
Other IDs
2023-507410-27-00, 2023
Status last verified
Apr 2026
First submitted
24 Dec 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.

    PubMed 39393433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Verekitug (UPB-101) in people with Severe Asthma, run by Upstream Bio Inc. at 155 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Argentina, Poland, Bulgaria, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual Asthma Exacerbation Rate (AAER) (time frame: Baseline up to Week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06196879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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