A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06914908Tipo: INTERVENTIONALInicio: 12 de may de 2025Fin estimado: 29 de ene de 2031

Traducción no disponible, mostrando original

Resumen

This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207). The study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.

Elegibilidad

Sexo: ALL

Criterios de inclusión

Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol.
Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS).
Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
Concurrent participation in any clinical study other than the parent study, including non-interventional studies.
Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant.
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Intervenciones

drug

lunsekimig

Pharmaceutical form: solution for injection Route of administration: subcutaneous

drug

Mometasone furoate nasal spray (MFNS)

Pharmaceutical form: Intranasal spray Route of administration: intranasal

Ubicaciones

Investigational Site Number : 0320002

Rosario, Santa Fe Province, Argentina

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, Argentina

RECRUITING

Investigational Site Number : 0320003

Mendoza, Argentina

RECRUITING

Patrocinadores

PrincipalSanofi

Contactos

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

Contact-US@sanofi.com 800-633-1610

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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