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

Active Not RecruitingPhase 2

Sponsor: Upstream Bio Inc.

Conditions: Severe Asthma

Interventions: Verekitug, Placebo

Countries: United States, Argentina, Bulgaria, Canada, Chile, Czechia, Germany, Italy

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (102)

Bakersfield, California, United States
Northridge, California, United States
Upland, California, United States
Walnut Creek, California, United States
Westminster, California, United States
Cutler Bay, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Boise, Idaho, United States
White Marsh, Maryland, United States
Farmington Hills, Michigan, United States
Flint, Michigan, United States
Las Vegas, Nevada, United States
The Bronx, New York, United States
Toledo, Ohio, United States
Edmond, Oklahoma, United States
Cypress, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
McKinney, Texas, United States
Tomball, Texas, United States
CABA, Argentina, Argentina
Córdoba, Córdoba Province, Argentina
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