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Clinical Trials in the UK / NCT06966479
Active, not recruiting Phase 2

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

NCT06966479 · tracked via the Priya Life Science UK tracker
Sponsor
Upstream Bio Inc.
Phase
Phase 2
Started
2025-05-21
Last updated
2026-05-14

Condition(s) studied

Severe Asthma

Investigational drug(s) / intervention(s)

VerekitugPlacebo

Verekitug: Verekitug subcutaneous injection.

Placebo: Verekitug matching placebo.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (102)

FacilityCityRegionStatus
Kern Research, Inc. Bakersfield California
California Medical Research Associates Inc. Northridge California
Integrated Research of Inland Inc Upland California
Allergy & Asthma Clinical Research Walnut Creek California
Allianz Research Institute Westminster California
Advance Pharma Research Cutler Bay Florida
Clinical Site Partners, LLC dba Flourish Research Miami Florida
Phoenix Medical Research Miami Florida
Research Institute of South Florida Miami Florida
Health and Life Research Institute, LLC Miami Florida
Nouvelle Clinical Research Miami Florida
Edward Jenner Research Group, LLC Plantation Florida
R&B Medical Center Tampa Florida
Clinical Site Partners dba Flourish research Winter Park Florida
Treasure Valley Medical Research Boise Idaho
Chesapeake Clinical Research Inc White Marsh Maryland
Pulmonary Research Institute of Southeast Michigan (PRISM) Farmington Hills Michigan
AA MRC Flint Michigan
M3 Wake Research Las Vegas Nevada
Urban Health Plan INC The Bronx New York
Toledo Institute of Clinical Research Inc Toledo Ohio
OK Clinical Research, LLC Edmond Oklahoma
Horizon Clinical Research Cypress Texas
Alina Clinical Trials, LLC Dallas Texas
El Paso Pulmonary Association El Paso Texas
California Medical Research Associates Inc. Houston Texas
Metroplex Pulmonary and Sleep Center Drive McKinney Texas
DM Clinical Tomball Tomball Texas
Fundacion Cidea CABA Argentina
Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC Córdoba Córdoba Province
Centro de Medicina Respiratoria Concepción del Uruguay Entre Ríos Province
Fundacion Scherbovsky Mendoza Mendoza Province
Investigaciones En Patologias Respiratorias San Miguel de Tucumán Tucumán Province
CARE: Centro de Alergia y Enfermedades Respiratorias Buenos Aires Argentina
Investigaciones en Alergias y Enfermedades Respiratorias-InAER Buenos Aires Argentina
INSARES Mendoza Argentina
Centro Medico Dharma Mendoza Argentina
Office of Hector H. Altieri MD San Miguel de Tucumán Argentina
Instituto Especialidades de la Salud Rosario Santa Fe Argentina
MHAT "Rahila Angelova" Pernik Pernik Pernik

+ 62 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06966479 on ClinicalTrials.gov ↗ ← All trials in the UK