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

NCT06966479 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: UPB-CP-052024-519469-23-00
• Study Type: interventional
• Target: 396
• Locations: 15 countries
• Sites: 102

Brief 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).

Conditions

Severe Asthma

Keywords

UPB-101; Verekitug; TSLP receptor; monoclonal antibody; VALIANT; VALOUR; Respiratory Tract Diseases; Bronchial Diseases; Asthma; Lung Diseases; Uncontrolled Asthma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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.

  From VALOUR baseline up to Week 64

Secondary Outcomes (4)

• Annualized Asthma Exacerbation Rate (AAER)

  From VALOUR baseline up to Week 60

• Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  From VALOUR baseline to Week 60

• Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)

  From VALOUR baseline up to Week 60

• Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6)

  From VALOUR baseline to Week 60

Study Arms (2)

Verekitug 100 mg Q12W and Placebo

EXPERIMENTAL

Participants will receive 0.5 mL of verekitug (100 mg) and 2.0 mL of matching placebo, subcutaneous (SC) injections, every 12 weeks (Q12W) for up to 48 weeks.

Drug: Verekitug; Drug: Placebo

Verekitug 400 mg Q24W and Placebo

EXPERIMENTAL

Participants will receive 2.0 mL of verekitug (400 mg) and 0.5 mL of matching placebo, SC injections, at Weeks 24 and 48 visits. Participants will also receive 2.0 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.

Drug: Verekitug; Drug: Placebo

Interventions

Placebo DRUG

Verekitug matching placebo.

Verekitug 100 mg Q12W and Placebo; Verekitug 400 mg Q24W and Placebo

Verekitug DRUG

Verekitug subcutaneous injection.

Also known as: UPB-101

Verekitug 100 mg Q12W and Placebo; Verekitug 400 mg Q24W and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of the VALIANT study (UPB-CP-04 \[NCT06196879\]) per protocol.
• Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study.
• Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if:

• Abnormal medical history, physical finding, or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant's safety.
• Any clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant's safety.
• Participant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction).
• 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.
• Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
• Participant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the Investigator or has any disorder that may compromise their ability to give informed consent.

Sponsors & Collaborators

• Upstream Bio Inc.: lead

Study Sites (102)

Kern Research, Inc.

Bakersfield, California, 93301, United States

Location

California Medical Research Associates Inc.

Northridge, California, 91324, United States

Location

Integrated Research of Inland Inc

Upland, California, 91786, United States

Location

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

Allianz Research Institute

Westminster, California, 92683, United States

Location

Advance Pharma Research

Cutler Bay, Florida, 33189, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Miami, Florida, 33135, United States

Location

Phoenix Medical Research

Miami, Florida, 33165, United States

Location

Research Institute of South Florida

Miami, Florida, 33173, United States

Location

Health and Life Research Institute, LLC

Miami, Florida, 33176, United States

Location

Nouvelle Clinical Research

Miami, Florida, 33189, United States

Location

Edward Jenner Research Group, LLC

Plantation, Florida, 33317, United States

Location

R&B Medical Center

Tampa, Florida, 33614, United States

Location

Clinical Site Partners dba Flourish research

Winter Park, Florida, 32789, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Chesapeake Clinical Research Inc

White Marsh, Maryland, 21162, United States

Location

Pulmonary Research Institute of Southeast Michigan (PRISM)

Farmington Hills, Michigan, 48336, United States

Location

AA MRC

Flint, Michigan, 48504, United States

Location

M3 Wake Research

Las Vegas, Nevada, 89106, United States

Location

Urban Health Plan INC

The Bronx, New York, 10459, United States

Location

Toledo Institute of Clinical Research Inc

Toledo, Ohio, 43617, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Horizon Clinical Research

Cypress, Texas, 77429, United States

Location

Alina Clinical Trials, LLC

Dallas, Texas, 75209, United States

Location

El Paso Pulmonary Association

El Paso, Texas, 79902, United States

Location

California Medical Research Associates Inc.

Houston, Texas, 77008, United States

Location

Metroplex Pulmonary and Sleep Center Drive

McKinney, Texas, 75069, United States

Location

DM Clinical Tomball

Tomball, Texas, 77375, United States

Location

Fundacion Cidea

CABA, Argentina, C1121ABE, Argentina

Location

Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC

Córdoba, Córdoba Province, X5003DCE, Argentina

Location

Centro de Medicina Respiratoria

Concepción del Uruguay, Entre Ríos Province, E3260, Argentina

Location

Fundacion Scherbovsky

Mendoza, Mendoza Province, 5500, Argentina

Location

Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, CP T4000IAP, Argentina

Location

CARE: Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, C1414AIF, Argentina

Location

Investigaciones en Alergias y Enfermedades Respiratorias-InAER

Buenos Aires, Argentina

Location

INSARES

Mendoza, 5500, Argentina

Location

Centro Medico Dharma

Mendoza, M5500, Argentina

Location

Office of Hector H. Altieri MD

San Miguel de Tucumán, 4000, Argentina

Location

Instituto Especialidades de la Salud Rosario

Santa Fe, 2000, Argentina

Location

MHAT "Rahila Angelova" Pernik

Pernik, Pernik, 2300, Bulgaria

Location

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

Rousse, Ruse, 7000, Bulgaria

Location

Medical Center Excelsior (Todor Popov)

Sofia, Sofia, 1407, Bulgaria

Location

MC Convex/DCC Convex

Sofia, Sofia, 1680, Bulgaria

Location

Medical Center New Rehabilitation Center EOOD

Stara Zagora, Stara Zagora, 6001, Bulgaria

Location

MC Zdrave 1

Kozloduy, Vratsa, 3320, Bulgaria

Location

Medical Center HERA EOOD

Sofia, 1510, Bulgaria

Location

Medical center Pulmovizhyn

Sofia, 1756, Bulgaria

Location

Dynamic Drug Advancement

Ajax, Ontario, L1S 2J5, Canada

Location

Estudios Clínicos de Enfermedades Respiratorias e Inmunológicas (CIERI)

Valparaíso, Región de Valparaíso, 2531172, Chile

Location

CIMER

Ñuñoa, Santiago Metropolitan, 7770484, Chile

Location

Fundacion Medica San Cristobal

Santiago, Santiago Metropolitan, 7630226, Chile

Location

Sociedad medica Sy G Limitada

Providencia, Santiago Metropolitana, CHL 7501126, Chile

Location

Plicni Stredisko Teplice S.R.O

Teplice, 415 01, Czechia

Location

RCMS/Lungenpraxis Hohenzollerndamm

Berlin, Germany, 10717, Germany

Location

IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

Hessen, Germany, 60596, Germany

Location

POIS Sachsen GmbH

Leipzig, Germany, 04347, Germany

Location

ME Clinical Respiratory Research Hamburg GmbH

Hamburg, Hamburg, 22299, Germany

Location

KPPK Studienzentrum

Bendorf, 56170, Germany

Location

IKF Pneumologie GmbH & Co. KG

Mainz, 55128, Germany

Location

UOC Pneumologia AOU Renato Dulbecco

Catanzaro, Catanzaro, 88100, Italy

Location

Tokyo-Eki Center-building Clinic

Tokyo, Chuo-ku, 103-0027, Japan

Location

Oji General Hospital

Hokkaido, Hokkaido, 053-8506, Japan

Location

Osaka Habikino Medical Center

Osaka, Japan, 583-8588, Japan

Location

Kishiwada City Hospital

Osaka, Japan, 596-8501, Japan

Location

National Hospital Organization Ibarakihigashi National Hospital

Ibaraki, Osaka, 319-1113, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka, 545-0051, Japan

Location

Fukuwa Clinic

Tokyo, Tokyo, 104-0031, Japan

Location

Centrum Badan Klinicznych Piotr Napora lekarze Spp

Wroclaw, Dolnoslaskie Voivodeship, 51-162, Poland

Location

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

Wroclaw, Dolnoslaskie Voivodeship, 53-201, Poland

Location

NZOZ J. Małolepszy i Partnerzy

Wroclaw, Dolnoslaskie Voivodeship, 54-239, Poland

Location

Centrum Medyczne "All-Med" Badania Kliniczne

Krakow, Malopolskie Voivodeship, 30-033, Poland

Location

ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Krakow, Malopolskie Voivodeship, 31-141, Poland

Location

Małopolskie Centrum Alergologii Spółka z ograniczoną odpowiedzialnością

Krakow, Malopolskie Voivodeship, 31-624, Poland

Location

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

Tarnów, Malopolskie Voivodeship, 33-100, Poland

Location

Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

Rzeszów, Podkarpackie Voivodeship, 35-051, Poland

Location

Centrum Medycyny Oddechowej, Mroz Spolka Jawna

Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii

Gdansk, Pomorskie Voivodeship, 80-214, Poland

Location

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

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

Emmed Research

Pretoria, Gauteng, 0002, South Africa

Location

Newtown CRC

Newtown, Johannesburg, 2001, South Africa

Location

St Augustine's Hospital/Dr. IA Abdullah

Durban, KwaZulu-Natal, 4001, South Africa

Location

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, 4001, South Africa

Location

Allergy & Immunology Unit, UCT Lung Institute

Cape Town, Western Cape, 7700, South Africa

Location

Yeungnam University Hospital

Daegu, Republic of Korea, 42415, South Korea

Location

Chungbuk National University Hospital

Jungbuk, Republic of Korea, 28644, South Korea

Location

Kyung Hee University Hospital

Seoul, Republic of Korea, 02447, South Korea

Location

Seoul National University Hospital

Seoul, Republic of Korea, 03080, South Korea

Location

Yonsei University Health System - Severance Hospital

Seoul, Republic of Korea, 03722, South Korea

Location

Asan Medical Center

Seoul, Republic of Korea, 05505, South Korea

Location

Samsung Medical Center

Seoul, Republic of Korea, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, Republic of Korea, 06591, South Korea

Location

Eunpyeong St. Marys Hospital

Seoul, South Korea, 03312, South Korea

Location

Pectus Respiratory Health

Barcelona, Catalonia, 08017, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"

Chernivtsi, Chernivtsi Oblast, 58000, Ukraine

Location

Municipal Non-Profit Enterprise "Center for Infectious Diseases of the Ivano-Frankivsk Regional Council"

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Gartnavel General Hospital (Glasgow Clinical Research Facility)

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Ashford & St Peters Hospital

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Gannochy Research Suite, Perth Royal Infirmary

Perth, Tayside, PH1 1NX, United Kingdom

Location

Bradford Royal Infirmary

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

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

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• James C Lee, MD

  Upstream Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 11, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (11); US (28); UA (2); CZ (1); PL (11); CA (1); BU (8); DE (6); IT (1); JP (7); KR (9); CL (4); ES (2); ZA (5); GB (6)