Estudio de fase 3b, multicéntrico, de extensión, para par... | EligiMed

Estudio de fase 3b, multicéntrico, de extensión, para participantes previamente enrolados en ensayos clínicos de povorcitinib

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06855498Tipo: INTERVENTIONALInicio: 28 de feb de 2025Fin estimado: 28 de feb de 2028

Resumen

Estudio de extensión para participantes provenientes de estudios clínicos principales predeterminados patrocinados por Incyte que evaluaron povorcitinib.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Ability to comprehend and willingness to sign a written ICF for the study.
Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
Willingness to avoid pregnancy or fathering children as defined in the protocol.
Willingness and ability to comply with the study Protocol and procedures.

Criterios de exclusión

Had been permanently discontinued from study treatment during the parent study.
Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:
Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
Live, attenuated vaccine.
Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Intervenciones

drug

povorcitinib

Study drug will be taken orally as defined by the protocol.

Ubicaciones

Investigative Site AR005

Buenos Aires, Argentina

NOT_YET_RECRUITING

Investigative Site AR002

Buenos Aires, Argentina

NOT_YET_RECRUITING

Investigative Site AR006

Buenos Aires, Argentina

NOT_YET_RECRUITING

Investigative Site AR004

Mar del Plata, Argentina

NOT_YET_RECRUITING

Investigative Site AR003

Rosario, Argentina

NOT_YET_RECRUITING

Investigative Site AR001

San Miguel de Tucumán, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalIncyte Corporation

Contactos

Incyte Corporation Call Center (US)

CONTACT

medinfo@incyte.com 1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

eumedinfo@incyte.com +800 00027423

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.