RecruitingPhase 2NCT06966479

A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)

A Long-Term Extension Study to Evaluate Safety and Efficacy of Verekitug (UPB-101) in Adult Participants With Severe Asthma Who Completed the VALIANT Trial


Sponsor

Upstream Bio Inc.

Enrollment

436 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This long-term extension study is assessing the ongoing safety and effectiveness of verekitug (UPB-101) — a biologic drug — in adults with severe asthma who previously completed the VALIANT clinical trial of the same drug. **You may be eligible if...** - You successfully completed the previous VALIANT study (NCT06196879) according to protocol - You have signed the consent form for this long-term extension - You are using an appropriate form of contraception as required by local guidelines **You may NOT be eligible if...** - You did not complete the VALIANT study - You have new medical conditions or findings that the investigator believes would interfere with participation - You have had significant safety events that would preclude continued treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVerekitug

Verekitug subcutaneous injection.

DRUGPlacebo

Verekitug matching placebo.


Locations(84)

Kern Research, Inc.

Bakersfield, California, United States

California Medical Research Associates Inc.

Northridge, California, United States

Integrated Research of Inland Inc

Upland, California, United States

Allergy & Asthma Clinical Research

Walnut Creek, California, United States

Allianz Research Institute

Westminster, California, United States

Advance Pharma Research

Cutler Bay, Florida, United States

Phoenix Medical Research

Miami, Florida, United States

Research Institute of South Florida

Miami, Florida, United States

Health and Life Research Institute, LLC

Miami, Florida, United States

Nouvelle Clinical Research

Miami, Florida, United States

Edward Jenner Research Group, LLC

Plantation, Florida, United States

R&B Medical Center

Tampa, Florida, United States

Clinical Site Partners dba Flourish research

Winter Park, Florida, United States

Treasure Valley Medical Research

Boise, Idaho, United States

Chesapeake Clinical Research Inc

White Marsh, Maryland, United States

Pulmonary Research Institute of Southeast Michigan (PRISM)

Farmington Hills, Michigan, United States

AA MRC

Flint, Michigan, United States

M3 Wake Research

Las Vegas, Nevada, United States

Urban Health Plan INC

The Bronx, New York, United States

Toledo Institute of Clinical Research Inc

Toledo, Ohio, United States

OK Clinical Research, LLC

Edmond, Oklahoma, United States

Alina Clinical Trials, LLC

Dallas, Texas, United States

El Paso Pulmonary Association

El Paso, Texas, United States

California Medical Research Associates Inc.

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center Drive

McKinney, Texas, United States

DM Clinical Tomball

Tomball, Texas, United States

Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC

Córdoba, Córdoba Province, Argentina

Fundacion Scherbovsky

Mendoza, Mendoza Province, Argentina

Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

CARE: Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Argentina

Investigaciones en Alergias y Enfermedades Respiratorias-InAER

Buenos Aires, Argentina

INSARES

Mendoza, Argentina

Centro Medico Dharma

Mendoza, Argentina

Office of Hector H. Altieri MD

San Miguel de Tucumán, Argentina

Instituto Especialidades de la Salud Rosario

Santa Fe, Argentina

MHAT "Rahila Angelova" Pernik

Pernik, Pernik, Bulgaria

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

Rousse, Ruse, Bulgaria

Medical Center Excelsior (Todor Popov)

Sofia, Sofia, Bulgaria

MC Convex/DCC Convex

Sofia, Sofia, Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, Stara Zagora, Bulgaria

MC Zdrave 1

Kozloduy, Vratsa, Bulgaria

Medical Center HERA EOOD

Sofia, Bulgaria

Medical center Pulmovizhyn

Sofia, Bulgaria

Dynamic Drug Advancement

Ajax, Ontario, Canada

CIMER

Ñuñoa, Santiago Metropolitan, Chile

Fundacion Medica San Cristobal

Santiago, Santiago Metropolitan, Chile

Sociedad medica Sy G Limitada

Providencia, Santiago Metropolitana, Chile

Plicni Stredisko Teplice S.R.O

Teplice, Czechia

RCMS/Lungenpraxis Hohenzollerndamm

Berlin, Germany, Germany

POIS Sachsen GmbH

Leipzig, Germany, Germany

ME Clinical Respiratory Research Hamburg GmbH

Hamburg, Hamburg, Germany

KPPK Studienzentrum

Bendorf, Germany

IKF Pneumologie GmbH & Co. KG

Mainz, Germany

Tokyo-Eki Center-building Clinic

Tokyo, Chuo-ku, Japan

Oji General Hospital

Hokkaido, Hokkaido, Japan

Osaka Habikino Medical Center

Osaka, Japan, Japan

Kishiwada City Hospital

Osaka, Japan, Japan

Fukuwa Clinic

Tokyo, Tokyo, Japan

ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy Marek Jutel

Wroclaw, Dolnoslaskie Voivodeship, Poland

NZOZ J. Małolepszy i Partnerzy

Wroclaw, Dolnoslaskie Voivodeship, Poland

Centrum Medyczne "All-Med" Badania Kliniczne

Krakow, Malopolskie Voivodeship, Poland

ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Krakow, Malopolskie Voivodeship, Poland

Małopolskie Centrum Alergologii Spółka z ograniczoną odpowiedzialnością

Krakow, Malopolskie Voivodeship, Poland

"Alergo-Med" Specjalistyczna Przychodnia Lekarska Spolka Z Ograniczona Odpowiedzialnoscia

Tarnów, Malopolskie Voivodeship, Poland

Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

Rzeszów, Podkarpackie Voivodeship, Poland

Centrum Medycyny Oddechowej, Mroz Spolka Jawna

Bialystok, Podlaskie Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii

Gdansk, Pomorskie Voivodeship, Poland

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

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Emmed Research

Pretoria, Gauteng, South Africa

Newtown CRC

Newtown, Johannesburg, South Africa

St Augustine's Hospital/Dr. IA Abdullah

Durban, KwaZulu-Natal, South Africa

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Allergy & Immunology Unit, UCT Lung Institute

Cape Town, Western Cape, South Africa

Yeungnam University Hospital

Daegu, Republic of Korea, South Korea

Chungbuk National University Hospital

Jungbuk, Republic of Korea, South Korea

Asan Medical Center

Seoul, Republic of Korea, South Korea

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, Republic of Korea, South Korea

Eunpyeong St. Marys Hospital

Seoul, South Korea, South Korea

Pectus Respiratory Health

Barcelona, Catalonia, Spain

Hospital Gregorio Marañon

Madrid, Madrid, Spain

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Cottingham, East Yorkshire, United Kingdom

Gartnavel General Hospital (Glasgow Clinical Research Facility)

Glasgow, Scotland, United Kingdom

Ashford & St Peters Hospital

Chertsey, Surrey, United Kingdom

Churchill Hospital - Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, United Kingdom

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NCT06966479


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