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
Systemic lupus erythematosus (SLE), commonly known as lupus, is an autoimmune condition where the immune system attacks healthy tissues. Treating lupus during pregnancy is important, but doctors need to know how medicines affect unborn babies. This research study focuses on a lupus medicine named dapirolizumab pegol. Doctors want to measure how much of the drug crosses from the mother to the baby through the placenta. To do this, blood samples will be taken from mothers and their babies around the time of birth, and for several weeks afterwards. Researchers will also carefully track the health, safety, and recovery of both mothers and infants. Standard medicines like paracetamol or antihistamines may be used to prevent or treat mild infusion reactions. Taking part helps doctors gather vital evidence about lupus treatments during pregnancy.
At a glance
What is this study about?
Lupus is a chronic illness where the body's defence system becomes overactive and attacks healthy joints, skin, and organs. Managing lupus well during pregnancy is essential for keeping both the mother and baby well. However, expectant mothers often have limited treatment choices because it is not always known how certain drugs pass through the placenta to the baby.
This clinical trial is studying a targeted medicine called dapirolizumab pegol in pregnant women who have active lupus. Researchers want to understand how the medicine behaves in the body during pregnancy and exactly how much of it reaches the developing baby. They do this by checking the levels of the drug in blood samples taken from both mother and baby at delivery and during the weeks after birth.
By taking part, mothers help researchers collect crucial safety information. The results will give doctors a clearer picture of how dapirolizumab pegol is processed by the body during pregnancy, which may help improve care and treatment decisions for women with lupus in the future.
Key takeaways
- Tests how much lupus medicine crosses the placenta to the baby.
- Open to pregnant women aged 18 and over with active lupus.
- Involves blood tests for mother and baby at delivery and in the weeks after.
- Participation is voluntary and runs alongside your normal care.
- Helps improve future treatment choices for pregnant women with lupus.
Who may be eligible?
This study is designed for adults aged 18 and older who are pregnant and have active systemic lupus erythematosus (SLE). Because this study focuses on pregnancy, it is open to expectant mothers who are taking or planned to receive dapirolizumab pegol.
Doctors will carefully check each person's overall health and pregnancy status before they join. You will need to be under specialist care for your lupus so the study team can work alongside your regular healthcare providers.
If you have certain other medical conditions, severe pregnancy complications, or cannot attend regular hospital check-ups, this study may not be suitable for you. Your clinical team will discuss your full medical history with you to ensure taking part is appropriate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I am currently pregnant.
- I have been diagnosed with active systemic lupus erythematosus (SLE).
- I am being treated with, or considered for, dapirolizumab pegol.
- I am able to attend clinic visits before and after birth.
What does participation involve?
If you take part, you will receive dapirolizumab pegol as part of your care during pregnancy, and you may choose to continue or stop it after giving birth, guided by your doctor. The study team may give you standard medicines such as paracetamol or an antihistamine beforehand to prevent common infusion reactions.
You and your baby will have regular health checks. Blood samples will be taken from you during pregnancy, at delivery, and up to 14 weeks after birth. Blood samples will also be collected from your baby at birth and during the early weeks of life to check medicine levels. The study lasts from your pregnancy through to about three months after your baby is born.
Potential risks and benefits
Locations (9)
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedGermany
Common questions
What is the main goal of this study?
The study aims to measure how much dapirolizumab pegol passes from a pregnant mother to her baby through the placenta, and to check the safety of both.
Will taking blood hurt my baby?
Trained healthcare professionals will take tiny blood samples using gentle, standard methods designed to keep discomfort to a minimum.
Do I have to keep taking the medicine after birth?
No, you and your doctor will decide together whether to continue or stop dapirolizumab pegol after your baby is born.
Can I leave the study if I change my mind?
Yes, taking part is completely voluntary. You can withdraw at any point, and your normal healthcare will continue as usual.
Will this study replace my regular antenatal care?
No, this study runs alongside your normal NHS maternity and lupus care to ensure you and your baby get full support.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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