Severe AsthmaPhase 2NCT06966479
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
A Phase 2 study testing Verekitug in people with Severe Asthma, run by Upstream Bio Inc. at 102 sites in 15 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Verekitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 102 sitesin 15 countries
- Study dates
- 21 May 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
102 sites in 15 countries.
102 sites in 15 countries
United States28 sites
Kern Research, Inc.
Bakersfield, California, 93301
Treasure Valley Medical Research
Boise, Idaho, 83706
Advance Pharma Research
Cutler Bay, Florida, 33189
Horizon Clinical Research
Cypress, Texas, 77429
Alina Clinical Trials, LLC
Dallas, Texas, 75209
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
El Paso Pulmonary Association
El Paso, Texas, 79902
Pulmonary Research Institute of Southeast Michigan (PRISM)
Farmington Hills, Michigan, 48336
AA MRC
Flint, Michigan, 48504
California Medical Research Associates Inc.
Houston, Texas, 77008
M3 Wake Research
Las Vegas, Nevada, 89106
Metroplex Pulmonary and Sleep Center Drive
McKinney, Texas, 75069
Clinical Site Partners, LLC dba Flourish Research
Miami, Florida, 33135
Phoenix Medical Research
Miami, Florida, 33165
Research Institute of South Florida
Miami, Florida, 33173
Health and Life Research Institute, LLC
Miami, Florida, 33176
Nouvelle Clinical Research
Miami, Florida, 33189
California Medical Research Associates Inc.
Northridge, California, 91324
Edward Jenner Research Group, LLC
Plantation, Florida, 33317
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
Allianz Research Institute
Westminster, California, 92683
Chesapeake Clinical Research Inc
White Marsh, Maryland, 21162
Clinical Site Partners dba Flourish research
Winter Park, Florida, 32789
Argentina11 sites
CARE: Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, C1414AIF
Investigaciones en Alergias y Enfermedades Respiratorias-InAER
Buenos Aires
Fundacion Cidea
CABA, Argentina, C1121ABE
Centro de Medicina Respiratoria
Concepción del Uruguay, Entre Ríos Province, E3260
Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC
Córdoba, Córdoba Province, X5003DCE
Fundacion Scherbovsky
Mendoza, Mendoza Province, 5500
INSARES
Mendoza, 5500
Centro Medico Dharma
Mendoza, M5500
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, CP T4000IAP
Office of Hector H. Altieri MD
San Miguel de Tucumán, 4000
Instituto Especialidades de la Salud Rosario
Santa Fe, 2000
Poland11 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" Badania Kliniczne
Krakow, Malopolskie Voivodeship, 30-033
ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
Krakow, Malopolskie Voivodeship, 31-141
Małopolskie Centrum Alergologii Spółka z ograniczoną odpowiedzialnością
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
"Alergo-Med" Specjalistyczna Przychodnia Lekarska Spolka Z Ograniczona Odpowiedzialnoscia
Tarnów, Malopolskie Voivodeship, 33-100
Centrum Badan Klinicznych Piotr Napora lekarze Spp
Wroclaw, Dolnoslaskie Voivodeship, 51-162
ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy Marek Jutel
Wroclaw, Dolnoslaskie Voivodeship, 53-201
NZOZ J. Małolepszy i Partnerzy
Wroclaw, Dolnoslaskie Voivodeship, 54-239
South Korea9 sites
Yeungnam University Hospital
Daegu, Republic of Korea, 42415
Chungbuk National University Hospital
Jungbuk, Republic of Korea, 28644
Kyung Hee University Hospital
Seoul, Republic of Korea, 02447
Seoul National University Hospital
Seoul, Republic of Korea, 03080
Yonsei University Health System - Severance Hospital
Seoul, Republic of Korea, 03722
Asan Medical Center
Seoul, Republic of Korea, 05505
Samsung Medical Center
Seoul, Republic of Korea, 06351
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, Republic of Korea, 06591
Eunpyeong St. Marys Hospital
Seoul, South Korea, 03312
Bulgaria8 sites
MC Zdrave 1
Kozloduy, Vratsa, 3320
MHAT "Rahila Angelova" Pernik
Pernik, Pernik, 2300
Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd
Rousse, Ruse, 7000
Medical Center Excelsior (Todor Popov)
Sofia, Sofia, 1407
MC Convex/DCC Convex
Sofia, Sofia, 1680
Medical Center HERA EOOD
Sofia, 1510
Medical center Pulmovizhyn
Sofia, 1756
Medical Center New Rehabilitation Center EOOD
Stara Zagora, Stara Zagora, 6001
Japan7 sites
Oji General Hospital
Hokkaido, Hokkaido, 053-8506
National Hospital Organization Ibarakihigashi National Hospital
Ibaraki, Osaka, 319-1113
Osaka Habikino Medical Center
Osaka, Japan, 583-8588
Kishiwada City Hospital
Osaka, Japan, 596-8501
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-0051
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027
Fukuwa Clinic
Tokyo, Tokyo, 104-0031
Germany6 sites
KPPK Studienzentrum
Bendorf, 56170
RCMS/Lungenpraxis Hohenzollerndamm
Berlin, Germany, 10717
ME Clinical Respiratory Research Hamburg GmbH
Hamburg, Free and Hanseatic City of Hamburg, 22299
IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
Hessen, Germany, 60596
POIS Sachsen GmbH
Leipzig, Germany, 04347
IKF Pneumologie GmbH & Co. KG
Mainz, 55128
United Kingdom6 sites
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
Ashford & St Peters Hospital
Chertsey, Surrey, KT16 0PZ
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham, East Yorkshire, HU16 5JQ
Gartnavel General Hospital (Glasgow Clinical Research Facility)
Glasgow, Scotland, G12 0YN
Churchill Hospital - Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, OX3 7LE
Gannochy Research Suite, Perth Royal Infirmary
Perth, Tayside, PH1 1NX
South Africa5 sites
Allergy & Immunology Unit, UCT Lung Institute
Cape Town, Western Cape, 7700
St Augustine's Hospital/Dr. IA Abdullah
Durban, KwaZulu-Natal, 4001
Synapta Clinical Research Centre
Durban, KwaZulu-Natal, 4001
Newtown CRC
Newtown, Johannesburg, 2001
Emmed Research
Pretoria, Gauteng, 0002
Chile4 sites
CIMER
Ñuñoa, Santiago Metropolitan, 7770484
Sociedad medica Sy G Limitada
Providencia, Santiago Metropolitana, CHL 7501126
Fundacion Medica San Cristobal
Santiago, Santiago Metropolitan, 7630226
Estudios Clínicos de Enfermedades Respiratorias e Inmunológicas (CIERI)
Valparaíso, Valparaiso, 2531172
Spain2 sites
Pectus Respiratory Health
Barcelona, Catalonia, 08017
Hospital Gregorio Marañon
Madrid, Madrid, 28007
Ukraine2 sites
Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, Chernivtsi Oblast, 58000
Municipal Non-Profit Enterprise "Center for Infectious Diseases of the Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
About this study
Official title: 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).
- Conditions
- Severe Asthma
- Being tested
- Verekitug, Placebo
- Keywords
- UPB-101, Verekitug, TSLP receptor, monoclonal antibody, VALIANT, VALOUR, Respiratory Tract Diseases, Bronchial Diseases, Asthma, Lung Diseases, Uncontrolled 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.
VerekitugDrug
Also called UPB-101
Verekitug subcutaneous injection.
PlaceboDrug
Verekitug matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Verekitug; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From VALOUR baseline up to Week 64
Secondary outcomes (4)
Annualized 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: From VALOUR baseline up to Week 60
Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
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: From VALOUR baseline to Week 60
Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Standardized single breath FeNO test is performed to evaluate airway inflammation.
Measured: From VALOUR baseline up to Week 60
Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6)
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: From VALOUR baseline to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start21 May 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upstream Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin Salciccioli, MD, Study director, Upstream Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966479
- Sponsor's protocol ID
- UPB-CP-05
- Other IDs
- 2024-519469-23-00
- Status last verified
- May 2026
- First submitted
- 9 May 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06966479
- Acronym / sponsor ID
- UPB-CP-05
- Conditions
- Severe Asthma
- Keywords
- UPB-101, Verekitug, TSLP receptor, monoclonal antibody, VALIANT, VALOUR, Respiratory Tract Diseases, Bronchial Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Upstream Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verekitug 100 mg Q12W and Placebo | Experimental | Drug: Verekitug, Drug: PlaceboParticipants 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. |
| Verekitug 400 mg Q24W and Placebo | Experimental | Drug: Verekitug, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerekitugAlso: UPB-101Verekitug subcutaneous injection. | Drug | Verekitug 100 mg Q12W and Placebo, Verekitug 400 mg Q24W and Placebo |
| PlaceboVerekitug matching placebo. | Drug | Verekitug 100 mg Q12W and Placebo, Verekitug 400 mg Q24W and Placebo |
Primary outcome
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.
4 secondary outcomes
Annualized Asthma Exacerbation Rate (AAER)
Time frame: 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
Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Salciccioli, MD study director
Upstream Bio
102 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verekitug in people with Severe Asthma, run by Upstream Bio Inc. at 102 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 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 102 sites in United States, Argentina, Poland, South Korea, Bulgaria 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From VALOUR baseline up to Week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.