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

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06966479Tipo: INTERVENTIONALInicio: 21 de may de 2025Fin estimado: 1 de sept de 2027

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Verekitug

Verekitug subcutaneous injection.

drug

Placebo

Verekitug matching placebo.

Ubicaciones

Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC

Córdoba, Córdoba Province, Argentina

RECRUITING

Fundacion Scherbovsky

Mendoza, Mendoza Province, Argentina

RECRUITING

Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

CARE: Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Argentina

RECRUITING

Investigaciones en Alergias y Enfermedades Respiratorias-InAER

Buenos Aires, Argentina

RECRUITING

INSARES

Mendoza, Argentina

RECRUITING

Centro Medico Dharma

Mendoza, Argentina

RECRUITING

Office of Hector H. Altieri MD

San Miguel de Tucumán, Argentina

RECRUITING

Instituto Especialidades de la Salud Rosario

Santa Fe, Argentina

RECRUITING

Patrocinadores

PrincipalUpstream Bio Inc.

Contactos

Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)

CONTACT

clinicaltrials@upstreambio.com 888-446-3130

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