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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 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

25

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: UCB Cares
  • Telefoonnummer: 001 844 599 2273

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Geneesmiddel: Dapirolizumab pegol (DZP)

Study participants will receive DZP at pre-specified timepoints

Andere namen:
  • CDP7657
  • DZP

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma concentration of DZP in the infants at birth
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

UCB Biopharma SRL

Onderzoekers

  • Studie directeur: UCB Cares, 001 844 599 22733 (UCB)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 november 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

30 september 2029

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UP0155
  • 2025 (Subsidie/contract van de Amerikaanse NIH)
  • 2025-524595-37 (Register-ID: EU Clinical Trials)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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