An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus

TerminadoFase 2ClinicalTrials.gov

ID: NCT05430854Tipo: INTERVENTIONALInicio: 1 de jun de 2022Fin estimado: 31 de oct de 2023

Traducción no disponible, mostrando original

Resumen

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Descripción detallada

Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study. Acquired from Horizon in 2024.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 72 YearsSexo: ALL

Criterios de inclusión

Willing and able to understand and provide written informed consent.
Must have completed the treatment period in the RECAST SLE study.
Women of childbearing potential must have a negative urine pregnancy test on Day 1.
Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.

Criterios de exclusión

Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
Participation in another clinical study with an IP during the RECAST SLE study period.
Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
Clinically significant active infection at Visit 1, in the opinion of the Investigator.
Pregnant or lactating females.

Intervenciones

biological

Daxdilimab

Daxdilimab will be administered subcutaneously as two injections for each dose.

Ubicaciones

Consultorios Médicos Dr. Doreski

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Clínica Adventista Belgrano

Estomba, Buenos Aires, Argentina

Framingham Centro Médico

La Plata, Buenos Aires, Argentina

Instituto CER S.A

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Consultorio de Investigaciones Reumatologicas

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalAmgen

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