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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. november 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

25

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: UCB Cares
  • Telefonnummer: 001 844 599 2273

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: Dapirolizumab pegol (DZP)

Study participants will receive DZP at pre-specified timepoints

Andre navn:
  • CDP7657
  • DZP

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma concentration of DZP in the infants at birth
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

UCB Biopharma SRL

Etterforskere

  • Studieleder: UCB Cares, 001 844 599 22733 (UCB)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. november 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

30. september 2029

Datoer for studieregistrering

Først innsendt

6. november 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UP0155
  • 2025 (U.S. NIH-stipend/kontrakt)
  • 2025-524595-37 (Registeridentifikator: EU Clinical Trials)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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Abonnere