Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

A Study to Evaluate the Placental Transfer of Dapirolizumab Pegol to the Infant(s) From Pregnant Study Participants With Active Systemic Lupus Erythematosus Who Are Administered Dapirolizumab Pegol

6 de noviembre de 2026 actualizado por: UCB Biopharma SRL

A Prospective, Open-Label, Single-Arm, Multicenter Pharmacokinetic Study Evaluating the Placental Transfer of Dapirolizumab Pegol to the Infant(s) From Pregnant Study Participants With Active Systemic Lupus Erythematosus Who Are Administered Dapirolizumab Pegol

The purpose of the study is to assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers who are administered DZP

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

25

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: UCB Cares
  • Número de teléfono: 001 844 599 2273

Copia de seguridad de contactos de estudio

  • Nombre: UCB Cares
  • Número de teléfono: +18445992273
  • Correo electrónico: ucbcares@ucb.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 45 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Participant must be greater than or equal to (≥)18 to less than or equal to (≤) 45 years of age at the time of signing the informed consent form (ICF)
  • Participant must be considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator
  • Participant is pregnant and at ≥14 gestational week (GW) and 0 days and <28 GW and 0 days at the time of the first dose of DZP in the study. An ultrasound examination and the last menstrual period (LMP) will be used to determine the estimated date of delivery, to document the gestational age for the study, and to document a viable intrauterine pregnancy
  • Participant has not been previously exposed to DZP
  • Participant has been diagnosed with SLE by a qualified physician (eg, rheumatologist, internal medicine expert, immunologist, nephrologist, or dermatologist) as confirmed by meeting the 2019 SLE EULAR/ACR classification criteria for SLE
  • Participant has an unmet medical need for a treatment intervention for SLE during their pregnancy as determined by the investigator based on the following criteria:

Maternal disease activity score as measured by a SLEPDAI score without serology ≥1 AND at least one of the risk factors specified in the protocol for SLE-associated maternal and/or fetal complications during pregnancy

- Body weight ≥40 kilograms (kg) and ≤150kg

Exclusion Criteria:

  • Study participant has any evidence or medical history of a known non-autoimmune obstetrical condition with a high likelihood for pregnancy loss, or her fetus has any medical or surgical condition or history that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the outcome of the pregnancy
  • Study participant has a history of chronic alcohol or drug abuse within the previous 24 weeks
  • Study participant has a known hypersensitivity to any components of DZP including polyethylene glycol (PEG) or comparative drugs (and/or an investigational device) as stated in this protocol

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dapirolizumab pegol (DZP)

Pregnant women will receive DZP by intravenous (iv) administration during 2nd and 3rd trimester and after delivery they may continue for up to 1 year (if not breastfeeding).
Droga: Dapirolizumab pegol (DZP)

Study participants will receive DZP at pre-specified timepoints

Otros nombres:
  • CDP7657
  • DZP

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma concentration of DZP in the infants at birth
Periodo de tiempo: At Birth during this study

Plasma concentration of DZP will be reported in infants at birth.
At Birth during this study
Plasma concentration of DZP in mothers at delivery
Periodo de tiempo: At Delivery during this study

Plasma concentration of DZP in mothers at delivery will be reported.
At Delivery during this study
Ratio between plasma concentration of DZP between the infants and mother at birth/delivery
Periodo de tiempo: Infants: At Birth; Mothers: At Delivery during this study

Ratio of plasma concentration of DZP between the infants and mother at birth/delivery will be reported.
Infants: At Birth; Mothers: At Delivery during this study

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
Periodo de tiempo: At 4 weeks, 8 weeks, and 12 weeks after birth

Plasma concentration of DZP at 4 weeks or 8 weeks, and at 12 weeks after birth in the infants from mothers continuing DZP treatment postpartum will be reported.
At 4 weeks, 8 weeks, and 12 weeks after birth
Predose and postdose plasma concentrations of DZP in mothers during pregnancy
Periodo de tiempo: Predose and postdose during second and third trimester

Predose and postdose plasma concentrations of DZP in mothers during pregnancy will be reported.
Predose and postdose during second and third trimester
DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum
Periodo de tiempo: Predose and postdose at Week 12 and Week 14 postpartum

DZP plasma concentrations at 12 weeks (predose and postdose) and 14 weeks postpartum in mothers continuing DZP treatment postpartum will be reported.
Predose and postdose at Week 12 and Week 14 postpartum
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum
Periodo de tiempo: At Week 12 postpartum

DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum will be reported.
At Week 12 postpartum
Treatment-emergent adverse events (TEAEs) of mothers
Periodo de tiempo: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs for the mothers will be considered TEAEs if they occur after the start of DZP treatment in this study.
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
Serious TEAEs of mothers
Periodo de tiempo: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)

An SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
TEAEs of special interest of mothers
Periodo de tiempo: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)

An AE of special interest is any AE that a regulatory authority has mandated to be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound.
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
TEAEs of special monitoring of mothers
Periodo de tiempo: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)

An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB.
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
AEs of infants
Periodo de tiempo: From birth to End of Safety Follow-Up (Up to 12 months)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From birth to End of Safety Follow-Up (Up to 12 months)
Serious AEs of infants
Periodo de tiempo: From birth to End of Safety Follow-Up (Up to 12 months)

An SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
From birth to End of Safety Follow-Up (Up to 12 months)
AEs of special interest of infants
Periodo de tiempo: From birth to End of Safety Follow-Up (Up to 12 months)

An AE of special interest is any AE that a regulatory authority has mandated to be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound.
From birth to End of Safety Follow-Up (Up to 12 months)
AEs of special monitoring of infants
Periodo de tiempo: From birth to End of Safety Follow-Up (Up to 12 months)

An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB.
From birth to End of Safety Follow-Up (Up to 12 months)
Pregnancy outcome
Periodo de tiempo: At the end of pregnancy during the study

Pregnancy outcome at the end of pregnancy during the study will be reported
At the end of pregnancy during the study
Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy
Periodo de tiempo: Second and Third Trimesters

Predicted AUC over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported.
Second and Third Trimesters
Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy
Periodo de tiempo: Second and Third Trimesters

Predicted Ctrough over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported.
Second and Third Trimesters
Predicted maximum plasma concentration (Cmax) over the dosing interval at steady state across the second and third trimesters of pregnancy
Periodo de tiempo: Second and Third Trimesters

Predicted Cmax over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported.
Second and Third Trimesters
Predicted AUC over the dosing interval at steady state across the postpartum
Periodo de tiempo: Up to 14 weeks of postpartum

Predicted AUC over the dosing interval at steady state across the postpartum will be reported.
Up to 14 weeks of postpartum
Predicted Ctrough over the dosing interval at steady state across the postpartum
Periodo de tiempo: Up to 14 weeks of postpartum

Predicted Ctrough over the dosing interval at steady state across the postpartum will be reported.
Up to 14 weeks of postpartum
Predicted Cmax over the dosing interval at steady state across the postpartum
Periodo de tiempo: Up to 14 weeks of postpartum

Predicted Cmax over the dosing interval at steady state across the postpartum will be reported.
Up to 14 weeks of postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

UCB Biopharma SRL

Investigadores

  • Director de estudio: UCB Cares, 001 844 599 22733 (UCB)

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de noviembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

30 de septiembre de 2029

Fechas de registro del estudio

Enviado por primera vez

6 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UP0155
  • 2025 (Subvención/contrato del NIH de EE. UU.)
  • 2025-524595-37 (Identificador de registro: EU Clinical Trials)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir