A study to learn how dapirolizumab pegol transfers to babies from pregnant mothers with active systemic lupus erythematosus
Key facts
- Where
- Barcelona és Vitoria, SpanyolországSee the 2 sites
- Phase
- 1. fázis
Where in Spanyolország
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországToborzás még nem indult
- Hospital Universitario ArabaVitoria, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UCB Biopharma
- Trial code
- EU 2025-524595-37-00
- Record updated
- 2026. október 5.
- Original description
To assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothersRead full original descriptionShow less
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
To assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers
Inclusion: 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 ≥50 kilograms (kg) and ≤150kg.
Exclusion: 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; 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.