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Dapirolizumab pegol Passing to Babies in Pregnant Women With Active Lupus

Studies how dapirolizumab pegol reaches babies of pregnant women with active lupus.

Key facts

Who runs it
UCB Biopharma
Where
DO NOT EDIT, DenmarkSee the siteAlso in 8 other countries, 9 sites
Trial code
Registry title
A study to learn how dapirolizumab pegol transfers to babies from pregnant mothers with active systemic lupus erythematosus
Status
Not yet recruiting
Phase
Phase 1
People taking part
10 people, planned
Starts
15 Jan 2027
Expected to end
20 Feb 2029
Type of study
Interventional
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant women with active lupus (SLE) who have not had dapirolizumab pegol before. It studies how the drug passes to the baby.

Age
18 to 45 years old at signing the consent form
Sex
Women who are pregnant
Disease stage
Lupus (SLE) diagnosed by a doctor, with active disease and a need for treatment during pregnancy, plus at least one risk factor for lupus-related complications
Earlier treatment
Must not have had dapirolizumab pegol (DZP) before

Main reasons for not taking part

  • A known non-autoimmune pregnancy condition with a high likelihood of pregnancy loss
  • A medical or surgical condition of the baby that could put the pregnancy or study at risk
  • Chronic alcohol or drug abuse in the previous 24 weeks
  • Known allergy to dapirolizumab pegol, including polyethylene glycol (PEG)

This trial only enrols pregnant participants. The registry sentence this rests on: 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.

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

Also in 8 other countries, 9 sites

  • Article 11 CTR DKDO NOT EDIT, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

To assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Dapirolizumab pegol Passing to Babies in Pregnant Women With Active LupusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
5 October 2026