El objetivo primario de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de dazodalibep.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all the following criteria apply:
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).

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
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.

Ubicaciones

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Instituto CER S.A.

Quilmes, Buenos Aires, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires, Argentina

RECRUITING

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

RECRUITING

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Centro Medico Privado de Reumatologia - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Aprillus Asistencia e Investigacion - Terrada 89

Buenos Aires, Argentina

RECRUITING

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Argentina

RECRUITING

Sanatorio Agote - Swiss Medical Group - PPDS

Buenos Aires, Argentina

RECRUITING

Centro Medico Arsema

Buenos Aires, Argentina

RECRUITING

Sanatorio Allende S.A.-Hipolito Yrigoyen 384

Córdoba, Argentina

RECRUITING

Framingham Centro Médico

La Plata, Argentina

RECRUITING

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

San Juan, Argentina

RECRUITING

Estudio de extensión a largo plazo, multicéntrico, abierto, para evaluar la seguridad y tolerabilidad de dazodalibep en participantes con síndrome de Sjögren (SS)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dazodalibep

Ubicaciones

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Instituto CER S.A.

Instituto de Investigaciones Clinicas Quilmes SRL

DOM Centro de Reumatología

Centro de Investigaciones Reumatológicas

Centro Medico Privado de Reumatologia - PPDS

Clínica Mayo de U.M.C.B. S.R.L

Aprillus Asistencia e Investigacion - Terrada 89

Hospital General de Agudos Dr. José María Ramos Mejia

Sanatorio Agote - Swiss Medical Group - PPDS

Centro Medico Arsema

Sanatorio Allende S.A.-Hipolito Yrigoyen 384

Framingham Centro Médico

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

Patrocinadores

Contactos

Amgen Call Center