Resumen del Estudio
Este estudio representa una etapa crucial de seguimiento para aquellos pacientes que ya completaron con éxito los ensayos clínicos de Fase 3 anteriores sobre Dazodalibep. El objetivo fundamental es evaluar la seguridad, la tolerabilidad y el comportamiento del fármaco cuando se administra durante un periodo prolongado de hasta 152 semanas. Al participar en esta extensión, los pacientes continúan bajo una estricta vigilancia médica, permitiendo a los investigadores recopilar datos vitales sobre el uso crónico de esta terapia biológica. Esto es esencial para confirmar que el medicamento sigue siendo seguro y eficaz para el manejo de los síntomas sistémicos y la sequedad característica del Síndrome de Sjögren a lo largo del tiempo.
Criterios de Elegibilidad
Resumen de Elegibilidad:Este estudio es exclusivo para pacientes que ya completaron los estudios previos de Fase 3 (HZNP-DAZ-301 o HZNP-DAZ-303). Deben estar libres de infecciones activas graves y no tener planes de recibir vacunas vivas atenuadas. Las mujeres en edad fértil deben evitar el embarazo.
- Participant has provided informed consent before initiation of any study specific activities/procedures.
- Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
- Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).
- Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
- Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
- Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.
- Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
- Individuals who plan to receive live (attenuated) vaccine during the LTE study.
- Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
- Female participants who are pregnant or lactating or planning to become pregnant during the study.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.