NCT06196879CompletedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 479 (actual)
- First submitted
- 24 Dec 2023
- Start date
- 27 Feb 2024
- Primary completion date
- 16 Dec 2025
- Lead sponsor
- Upstream Bio Inc.
- Diseases
- Asthma
- NCT number
- NCT06196879
- EU CT number
- 2023-507410-27-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 479
- From 27 Feb 2024 to the primary completion date, 16 Dec 2025
- 157 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (157)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CARE - Centro de Alergia y Enfermedades Respiratorias Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Respirar - Centro Medico Dra. De Salvo Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Cidea Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| InAER Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro de Medicina Respiratoria Coordinator of this site? Confirm its status | Concepción del Uruguay | Argentina | Unknown status |
| Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro Medico Dharma Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| INSARES Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Fundacion Scherbovsky Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Fundacion Estudios Clinicos (FECLIN) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Instituto Especialidades de la Salud Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica Coordinator of this site? Confirm its status | San Juan Bautista | Argentina | Unknown status |
| Office of Hector H. Altieri MD Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Investigaciones en Patologias Respiratorias Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Medical Center Zdrave-1 OOD Coordinator of this site? Confirm its status | Kozloduy | Bulgaria | Completed |
| Rahila Angelova Mbal AD Coordinator of this site? Confirm its status | Pernik | Bulgaria | Completed |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| Diagnostic Consultative Center Sveti Georgi EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Ambulatory For Specialized Outpatient Medical Care Individual Practice Dr. Nikolay Evgeniev Ruse EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| Medical Center Hermes Ruse Ltd. Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| Medical Center Pulmovision Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medical Center Excelsior OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medical Center New Rehabilitation Center EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Completed |
| Dynamic Drug Advancement Coordinator of this site? Confirm its status | Ajax | Canada | Unknown status |
| Ottawa Allergy Research Corp Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Toronto Allergists Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Winchester Hospital Coordinator of this site? Confirm its status | Winchester | Canada | Unknown status |
| Centro Médico BIOREUMA Coordinator of this site? Confirm its status | Concepción | Chile | Unknown status |
| CIMER Coordinator of this site? Confirm its status | Providencia | Chile | Unknown status |
| Sociedad medica Sy G Limitada Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Fundacion Medica San Cristobal Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Icegclinic Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Hofstetr Alois MUDr. s.r.o. Coordinator of this site? Confirm its status | Jihlava | Czechia | Completed |
| Plicni Stredisko Teplice S.R.O Coordinator of this site? Confirm its status | Teplice | Czechia | Completed |
| PNEUMOLOGIE VARNSDORF s.r.o. Coordinator of this site? Confirm its status | Varnsdorf | Czechia | Completed |
| Lungenpraxis Hohenzollerndamm Research Center for Medical Studies Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Velocity Clinical Research GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| "Pneumologisches Studienzentrum MVZ die Lungenaerzte" Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| ME Clinical Respiratory Research Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| KPPK GmbH Coordinator of this site? Confirm its status | Koblenz | Germany | Completed |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Luebeck | Germany | Completed |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Giromed Institute S.L.P. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Ormeau Clinical Trials Ltd Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Heartlands Hospital, University Hospitals Birmingham NHS Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Bradford Royal Infirmary Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Duckworth Lane Clinical Research Facility Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| St Peter's Hospital Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| Hull University Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Cottingham | United Kingdom | Unknown status |
| Asthma/COPD Clinical Research Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinics Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Osaka Habikino Medical Center Coordinator of this site? Confirm its status | Habikino | Japan | Unknown status |
| National Hospital Organization Ibarakihigashi National Hospital Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| Kishiwada City Hospital Coordinator of this site? Confirm its status | Kishiwada | Japan | Unknown status |
| Osaka Metropolitan University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| KKR Sapporo Medical Center Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Oji General Hospital Coordinator of this site? Confirm its status | Tomakomai | Japan | Unknown status |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Soonchunhyang University Bucheon Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Yeungnam University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Eunpyeong St. Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Centrum Medycyny Oddechowej Mroz sp. j. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Malopolskie Centrum Alergologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| NZOZ Poradnia Specjalistyczna Atopia Grażyna Jasieniak-Pinis Coordinator of this site? Confirm its status | Kraków | Poland | Completed |
| Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c. Coordinator of this site? Confirm its status | Ostrowiec Świętokrzyski | Poland | Completed |
| Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| EMED Centrum Uslug Medycznych Ewa Smialek Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o. Coordinator of this site? Confirm its status | Tarnów | Poland | Completed |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Lekarze Specjalisci - J. Malolepszy I Partnerzy Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy Marek Jutel Coordinator of this site? Confirm its status | Wrocław | Poland | Completed |
| Chernivtsi Regional Clinical Hospital Coordinator of this site? Confirm its status | Chernivtsi | Ukraine | Unknown status |
| Municipal non-Profit Enterprise "lvano-Frankivsk Regional Phthisiology-Pulmonology Center of lvano-Frankivsk regional council Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| Medical Centre "Neuromed" of Limited Liability Company "Scan Light" Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Velocity Clinical Research, Anderson Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Kern Research, Inc Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| AllerVie Clinical Research Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Treasure Valley Medical Research Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| WR-Notus Clinical Research, LLC Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| WR-ClinSearch, LLC Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Portland Clinical Research Coordinator of this site? Confirm its status | Clackamas | United States | Unknown status |
| Howard County Center for Lung and Sleep Medicine LLC Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Advance Pharma Research Coordinator of this site? Confirm its status | Cutler Bay | United States | Unknown status |
| Horizon Clinical Research Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Alina Clinical Trials, LLC. Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| AARA Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Unique Clinical Trials Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| OK Clinical Research, LLC Coordinator of this site? Confirm its status | Edmond | United States | Unknown status |
| El Paso Pulmonary Association Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Exordia Medical Research Inc Coordinator of this site? Confirm its status | Fall River | United States | Unknown status |
| Pulmonary Research Institute of Southeast Michigan Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| AA Medical Research Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Greater Houston Memorial Pulmonary and Sleep Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Advanced Respiratory and Sleep Medicine LLC Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Sante Clinical Research Coordinator of this site? Confirm its status | Kerrville | United States | Unknown status |
| M3 Wake Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Velocity Clinical Research - Lafayette LA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Mayflower Clinical Coordinator of this site? Confirm its status | Marble Falls | United States | Unknown status |
| Metroplex Pulmonary and Sleep Center Drive Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| Velocity Clinical Research, Medford Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| Velocity Clinical Research, Meridian Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| Health and Life Research Institute, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Nouvelle Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Research Institute of South Florida Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Phoenix Medical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Summit Research Group LLC Coordinator of this site? Confirm its status | Munroe Falls | United States | Unknown status |
| Newport Native Md, Inc. Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| California Medical Research Associates Inc. Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Anderson Allergy And Asthma, PA Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Edward Jenner Research Group LLC Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Element Research Group Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Velocity Clinical Research, Spartanburg Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Pivotal Research Solutions Coordinator of this site? Confirm its status | Stonecrest | United States | Unknown status |
| RNA America Health Sciences Coordinator of this site? Confirm its status | Sugar Hill | United States | Unknown status |
| R&B Medical Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Urban Health Plan INC Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Toledo Institute of Clinical Research Inc. Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| DM Clinical Tomball Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Integrated Research of Inland, Inc. Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Allergy & Asthma Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | West Jordan | United States | Unknown status |
| Allianz Research Institute Coordinator of this site? Confirm its status | Westminster | United States | Unknown status |
| Chesapeake Clinical Research, Inc. Coordinator of this site? Confirm its status | White Marsh | United States | Unknown status |
| Clinical Site Partners dba Flourish research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Clinical Site Partners, LLC dba Flourish Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Woodland Clinic Medical Group Coordinator of this site? Confirm its status | Woodland | United States | Unknown status |
| University of Cape Town Lung Institute Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| St Augustine's Hospital/Dr. IA Abdullah Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Synapta Clinical Research Centre Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Newtown Clinical Research Centre Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Emmed Research Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| FCRN Clinical Trial Centre Coordinator of this site? Confirm its status | Vereeniging | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.