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

May 12, 2026 updated by: Upstream Bio Inc.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • 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 Locations

  • Argentina
      • Buenos Aires, Argentina, C1414AIF
        • CARE: Centro de Alergia y Enfermedades Respiratorias
      • Buenos Aires, Argentina
        • Investigaciones en Alergias y Enfermedades Respiratorias-InAER
      • Mendoza, Argentina, M5500
        • Centro Medico Dharma
      • Mendoza, Argentina, 5500
        • INSARES
      • San Miguel de Tucumán, Argentina, 4000
        • Office of Hector H. Altieri MD
      • Santa Fe, Argentina, 2000
        • Instituto Especialidades de la Salud Rosario
    • Argentina
      • CABA, Argentina, Argentina, C1121ABE
        • Fundacion CIDEA
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5003DCE
        • Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC
    • Entre Ríos Province
      • Concepción del Uruguay, Entre Ríos Province, Argentina, E3260
        • Centro de Medicina Respiratoria
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, 5500
        • Fundación Scherbovsky
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, CP T4000IAP
        • Investigaciones en Patologias Respiratorias
  • Bulgaria
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1756
        • Medical center Pulmovizhyn
    • Pernik
      • Pernik, Pernik, Bulgaria, 2300
        • MHAT "Rahila Angelova" Pernik
    • Ruse
      • Rousse, Ruse, Bulgaria, 7000
        • Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
    • Sofia
      • Sofia, Sofia, Bulgaria, 1407
        • Medical Center Excelsior (Todor Popov)
      • Sofia, Sofia, Bulgaria, 1680
        • MC Convex/DCC Convex
    • Stara Zagora
      • Stara Zagora, Stara Zagora, Bulgaria, 6001
        • Medical Center New Rehabilitation Center EOOD
    • Vratsa
      • Kozloduy, Vratsa, Bulgaria, 3320
        • MC Zdrave 1
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Dynamic Drug Advancement
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7630226
        • Fundacion Medica San Cristobal
      • Ñuñoa, Santiago Metropolitan, Chile, 7770484
        • CIMER
    • Santiago Metropolitana
      • Providencia, Santiago Metropolitana, Chile, CHL 7501126
        • Sociedad medica Sy G Limitada
    • Valparaiso
      • Valparaíso, Valparaiso, Chile, 2531172
        • Estudios Clínicos de Enfermedades Respiratorias e Inmunológicas (CIERI)
  • Czechia
      • Teplice, Czechia, 415 01
        • Plicni Stredisko Teplice S.R.O
  • Germany
      • Bendorf, Germany, 56170
        • KPPK Studienzentrum
      • Mainz, Germany, 55128
        • IKF Pneumologie GmbH & Co. KG
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22299
        • ME Clinical Respiratory Research Hamburg GmbH
    • Germany
      • Berlin, Germany, Germany, 10717
        • RCMS/Lungenpraxis Hohenzollerndamm
      • Hessen, Germany, Germany, 60596
        • IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
      • Leipzig, Germany, Germany, 04347
        • POIS Sachsen GmbH
  • Italy
    • Catanzaro
      • Catanzaro, Catanzaro, Italy, 88100
        • UOC Pneumologia AOU Renato Dulbecco
  • Japan
    • Chuo-ku
      • Tokyo, Chuo-ku, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
    • Hokkaido
      • Hokkaido, Hokkaido, Japan, 053-8506
        • Oji General Hospital
    • Japan
      • Osaka, Japan, Japan, 583-8588
        • Osaka Habikino Medical Center
      • Osaka, Japan, Japan, 596-8501
        • Kishiwada City Hospital
    • Osaka
      • Ibaraki, Osaka, Japan, 319-1113
        • National Hospital Organization Ibarakihigashi National Hospital
      • Osaka, Osaka, Japan, 545-0051
        • Osaka Metropolitan University Hospital
    • Tokyo
      • Tokyo, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
  • Poland
    • Dolnoslaskie Voivodeship
      • Wroclaw, Dolnoslaskie Voivodeship, Poland, 51-162
        • Centrum Badan Klinicznych Piotr Napora lekarze Spp
      • Wroclaw, Dolnoslaskie Voivodeship, Poland, 53-201
        • ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy Marek Jutel
      • Wroclaw, Dolnoslaskie Voivodeship, Poland, 54-239
        • NZOZ J. Małolepszy i Partnerzy
    • Malopolskie Voivodeship
      • Krakow, Malopolskie Voivodeship, Poland, 30-033
        • Centrum Medyczne "All-Med" Badania Kliniczne
      • Krakow, Malopolskie Voivodeship, Poland, 31-141
        • ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
      • Krakow, Malopolskie Voivodeship, Poland, 31-624
        • Małopolskie Centrum Alergologii Spółka z ograniczoną odpowiedzialnością
      • Tarnów, Malopolskie Voivodeship, Poland, 33-100
        • "Alergo-Med" Specjalistyczna Przychodnia Lekarska Spolka Z Ograniczona Odpowiedzialnoscia
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-051
        • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
    • 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
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0002
        • Emmed Research
    • Johannesburg
      • Newtown, Johannesburg, South Africa, 2001
        • Newtown CRC
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Synapta Clinical Research Centre
      • Durban, KwaZulu-Natal, South Africa, 4001
        • St Augustine's Hospital/Dr. IA Abdullah
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Allergy & Immunology Unit, UCT Lung Institute
  • South Korea
    • Republic of Korea
      • Daegu, Republic of Korea, South Korea, 42415
        • Yeungnam University Hospital
      • Seoul, Republic of Korea, South Korea, 06351
        • Samsung Medical Center
      • Seoul, Republic of Korea, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital
      • Seoul, Republic of Korea, South Korea, 02447
        • Kyung Hee University Hospital
      • Seoul, Republic of Korea, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, Republic of Korea, South Korea, 03722
        • Yonsei University Health System - Severance Hospital
      • Seoul, Republic of Korea, South Korea, 05505
        • Asan Medical Center
      • Taebuk, Republic of Korea, South Korea, 28644
        • Chungbuk National University Hospital
    • South Korea
      • Seoul, South Korea, South Korea, 03312
        • Eunpyeong St. Marys Hospital
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08017
        • Pectus Respiratory Health
    • Madrid
      • Madrid, Madrid, Spain, 28007
        • Hospital Gregorio Marañón
  • Ukraine
    • Chernivtsi Oblast
      • Chernivtsi, Chernivtsi Oblast, Ukraine, 58000
        • Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Municipal Non-Profit Enterprise "Center for Infectious Diseases of the Ivano-Frankivsk Regional Council"
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital - Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Gartnavel General Hospital (Glasgow Clinical Research Facility)
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Ashford & St Peters Hospital
    • Tayside
      • Perth, Tayside, United Kingdom, PH1 1NX
        • Gannochy Research Suite, Perth Royal Infirmary
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research, 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
    • Florida
      • Cutler Bay, Florida, United States, 33189
        • Advance Pharma Research
      • Miami, Florida, United States, 33165
        • Phoenix Medical Research
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida
      • Miami, Florida, United States, 33189
        • Nouvelle Clinical Research
      • Miami, Florida, United States, 33135
        • Clinical Site Partners, LLC dba Flourish Research
      • Miami, Florida, United States, 33176
        • Health and Life Research Institute, LLC
      • 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 dba Flourish research
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Chesapeake Clinical Research Inc
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Pulmonary Research Institute of Southeast Michigan (PRISM)
      • Flint, Michigan, United States, 48504
        • AA MRC
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • M3 Wake Research
    • New York
      • The Bronx, New York, United States, 10459
        • Urban Health Plan INC
    • Ohio
      • Toledo, Ohio, United States, 43617
        • Toledo Institute of Clinical Research Inc
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • OK Clinical Research, LLC
    • Texas
      • Cypress, Texas, United States, 77429
        • Horizon Clinical Research
      • Dallas, Texas, United States, 75209
        • Alina Clinical Trials, LLC
      • El Paso, Texas, United States, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, United States, 77008
        • California Medical Research Associates Inc.
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center Drive
      • Tomball, Texas, United States, 77375
        • DM Clinical Tomball

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Completion of the VALIANT study (UPB-CP-04 [NCT06196879]) per protocol.
  2. 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.
  3. Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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).
  4. 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.
  5. Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
  6. 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.

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
Intervention / Treatment
Experimental: Verekitug 100 mg Q12W and Placebo
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
Verekitug subcutaneous injection.
Other Names:
  • UPB-101
Drug: Placebo
Verekitug matching placebo.
Experimental: Verekitug 400 mg Q24W and Placebo
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
Verekitug subcutaneous injection.
Other Names:
  • UPB-101
Drug: Placebo
Verekitug matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From VALOUR baseline 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.
From VALOUR baseline up to Week 64

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Asthma Exacerbation Rate (AAER)
Time Frame: From VALOUR 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.
From VALOUR baseline up to Week 60
Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: From VALOUR 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.
From VALOUR baseline to Week 60
Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: From VALOUR baseline up to Week 60
Standardized single breath FeNO test is performed to evaluate airway inflammation.
From VALOUR baseline up to Week 60
Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6)
Time Frame: From VALOUR 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.
From VALOUR baseline to Week 60

Collaborators and Investigators

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

Sponsor

Upstream Bio Inc.

Investigators

  • 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)

May 21, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 9, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPB-CP-05
  • 2024-519469-23-00 (Ctis)

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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