2025-524595-37-00Not yet recruitingPhase 1
A study to learn how dapirolizumab pegol transfers to babies from pregnant mothers with active systemic lupus erythematosus
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026
Brief summary (registry, in English)
To assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 15 Jan 2027
- Lead sponsor
- UCB Biopharma
- Diseases
- Lupus (SLE)
- EU CT number
- 2025-524595-37-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- 10 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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.
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | Not yet recruiting |
| UZ Leuven | Leuven | Belgium | Not yet recruiting |
| LMU Klinikum Muenchen AöR | Munich | Germany | Not yet recruiting |
| Article 11 CTR DK | DO NOT EDIT | Denmark | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Araba | Vitoria | Spain | Not yet recruiting |
| Article 11 CTR GR | DO NOT EDIT | Greece | Not yet recruiting |
| Article 11 CTR IT | DO NOT EDIT | Italy | Not yet recruiting |
| Article 11 CTR NL | DO NOT EDIT | Netherlands | Not yet recruiting |
| Article 11 CTR SE | DO NOT EDIT | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.