A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
NCT ID: NCT06966479
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
436 participants
INTERVENTIONAL
2025-05-21
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Verekitug
Verekitug subcutaneous injection.
Placebo
Verekitug matching placebo.
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.
Verekitug
Verekitug subcutaneous injection.
Placebo
Verekitug matching placebo.
Interventions
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Verekitug
Verekitug subcutaneous injection.
Placebo
Verekitug matching placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Upstream Bio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James C Lee, MD
Role: STUDY_DIRECTOR
Upstream Bio
Locations
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California Medical Research Associates Inc.
Northridge, California, United States
Allianz Research Institute
Westminster, California, United States
Phoenix Medical Research
Miami, Florida, United States
Health and Life Research Institute, LLC
Miami, Florida, United States
Edward Jenner Research Group, LLC
Plantation, 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
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
Metroplex Pulmonary and Sleep Center Drive
McKinney, Texas, United States
DM Clinical Tomball
Tomball, Texas, United States
Medical Center New Rehabilitation Center EOOD
Stara Zagora, Stara Zagora, Bulgaria
Dynamic Drug Advancement
Ajax, Ontario, Canada
Fukuwa Clinic
Tokyo, Tokyo, Japan
Countries
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Central Contacts
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Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)
Role: CONTACT
Phone: 888-446-3130
Email: [email protected]
Other Identifiers
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2024-519469-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
UPB-CP-05
Identifier Type: -
Identifier Source: org_study_id