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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Severe Asthma

In brief

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).

Key facts

Study ID

NCT06966479

Run by

Upstream Bio Inc.

People needed

396

Starts

2025-05-21

Expected to finish

2027-09-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Clinical Site Partners, LLC dba Flourish Research — Miami, 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
• Horizon Clinical Research — Cypress, Texas, United States
• Alina Clinical Trials, LLC — Dallas, Texas, United States
• El Paso Pulmonary Association — El Paso, Texas, United States
• Kern Research, Inc. — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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