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Study of dapirolizumab pegol placental transfer to infants in pregnant women with active systemic lupus erythematosus (drug combination)

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves pregnant women who have active Systemic lupus erythematosus, an autoimmune condition in which the body’s immune system mistakenly attacks its own organs. These participants will receive the investigational medication dapirolizumab pegol, which is given by intravenous infusion. The aim of the research is to learn how the medication moves from the mother to the baby across the placenta.

During the pregnancy, the medication will be administered at scheduled times, and blood samples will be collected from the mother and, at birth, from the infant to measure the amount of drug present in the blood’s liquid part (plasma). After delivery, additional blood samples may be taken from the infant and the mother, especially if the mother continues the medication, to monitor how the drug levels change and to observe any side effects. The follow‑up period extends for several weeks after birth to record any health concerns in both mother and baby.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and first infusion
After joining the study, you will attend an initial visit where your health status and the activity of systemic lupus erythematosus are checked. a blood sample will be taken from you to measure baseline levels of the study drug.
You will receive the first dose of dapirolizumab pegol by intravenous infusion. the exact amount and how often it will be given follow the study schedule, which is not disclosed here.
Step 2
Regular infusion visits during pregnancy
Throughout the second and third trimesters of pregnancy you will return to the clinic for additional intravenous infusions of dapirolizumab pegol. each visit includes a blood draw before the infusion (predose) and another draw after the infusion (postdose) to measure the drug level in your blood.
During these visits the study team will also check for any side effects or health changes in you and in the developing baby.
Step 3
Monitoring for safety during pregnancy
At any time while you are pregnant, you may be asked to report symptoms or adverse events. the study staff will record any treatment‑emergent adverse events, serious adverse events, and events of special interest for both you and the infant.
Step 4
Delivery and birth sampling
When you give birth, a blood sample will be taken from you and from the newborn. these samples are used to determine the concentration of dapirolizumab pegol in the mother and the infant at the moment of delivery.
Step 5
Postpartum treatment decisions
After delivery you will either continue or stop receiving dapirolizumab pegol based on the study protocol. if you continue, you will have additional infusions and blood draws at approximately 12 weeks and 14 weeks after delivery. if you stop, a single blood draw will be performed at about 12 weeks postpartum.
Step 6
Infant follow‑up after birth
If you continue the study drug after delivery, the infant will have blood samples taken after birth to assess how much drug has passed from mother to baby. the infant will also be monitored for any adverse events throughout the postpartum period.
Step 7
Final study assessments
At the end of the study period, all collected data—including drug concentrations, safety information, and pregnancy outcome—will be reviewed. no further treatment related to the study will be given after this final assessment.

Who can join the trial?

8 criteria

Age must be at least 18 years and no more than 45 years when you sign the consent form.
You need to be considered reliable and able to follow the study schedule, as judged by the doctor.
You must be pregnant and between 14 weeks (inclusive) and 28 weeks (exclusive) of pregnancy when you receive the first dose. Your pregnancy age will be confirmed with an ultrasound (an imaging test) and by noting the last menstrual period (LMP) (the first day of your last period) to ensure a viable intrauterine pregnancy (a living pregnancy inside the uterus).
You must not have taken the study drug dapirolizumab pegol (DZP) before.
You must have been diagnosed with Systemic lupus erythematosus (SLE) by a qualified doctor (such as a rheumatologist) and meet the 2019 SLE EULAR/ACR classification criteria (a set of guidelines doctors use to confirm the disease).
You need an unmet medical need for SLE treatment during pregnancy, meaning:
- Your disease activity score called the SLEPDAI score (a measure of how active the lupus is) without blood test results (serology) must be at least 1, and
- You must have at least one risk factor that could lead to maternal or fetal complications (problems for you or the baby) as defined by the study.
- Your body weight must be at least 50 kilograms (kg) and no more than 150 kilograms (kg).

Who cannot join the trial?

3 criteria

You have a pregnancy‑related condition (not an autoimmune disease) that is very likely to cause a miscarriage, or your baby has a medical or surgical problem that could affect your ability to stay in the study or the pregnancy’s outcome. Obstetrical condition means a condition related to pregnancy, and pregnancy loss means miscarriage.
You have used alcohol or illegal drugs heavily (chronic abuse) in the last 24 weeks (about six months). This means regular, long‑term use that could affect your health.
You are allergic (hypersensitive) to any part of the study drug dapirolizumab pegol (DZP), including a substance called polyethylene glycol (PEG) or similar medicines.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Hospital Universitario Araba
Verified
Vitoria, Spain
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

Epinephrine
is a medication that quickly raises blood pressure and helps improve breathing. In this study it is listed as a background treatment, meaning it may be given if needed for emergency situations, but it is not the main drug being tested.
Paracetamol
(also known as acetaminophen) is a pain reliever and fever reducer. In the trial it is combined with buclizine, which helps prevent nausea, and codeine, an opioid that adds extra pain relief. These medicines are used as background therapy to manage symptoms that the participants might have, but they are not the focus of the study.
Dapirolizumab pegol
is the experimental drug being studied. It is a type of protein called a monoclonal antibody that is given through an IV infusion. The trial is looking at how this medicine moves from a pregnant mother’s blood across the placenta to the baby, to understand its safety and behavior in pregnancy.
Diphenhydramine
is an antihistamine that helps reduce allergic reactions, itching, and can also be used as a mild sleep aid. In the study it is considered a background medication, meaning participants might receive it for allergy symptoms, but it is not the primary drug under investigation.

What is already known about the treatment

EPINEPHRINE
This medication is given by injection, usually into a vein or muscle. It is an approved drug that has been used for many years and is well described in medical literature. It is mainly used for severe allergic reactions, heart arrest, and breathing problems. It works by activating certain receptors that raise heart rate, tighten blood vessels, and open the airways, and it is classified as a sympathomimetic (a catecholamine).
PARACETAMOL
The product is taken by mouth as a tablet that contains paracetamol, codeine and buclizine. It is a widely available medicine that is listed in many treatment guidelines and research studies. It is used to relieve mild to moderate pain, reduce fever, and help with nausea or motion sickness. Paracetamol reduces pain signals, codeine binds to opioid receptors to further ease pain, and buclizine blocks histamine to calm nausea, making the combination an analgesic/antipyretic with opioid and antihistamine effects.
Dapirolizumab pegol
This drug is given as a solution that is infused slowly into a vein. It is still experimental and is being studied in clinical trials for its safety and how it passes from mother to baby. It is being tested for treating systemic lupus erythematosus, an autoimmune disease. The medicine is a specially designed antibody that blocks a protein called CD40 ligand, which slows down the over‑active immune system, and it belongs to the class of biologic immunomodulators.
DIPHENHYDRAMINE
The medication can be taken by mouth or applied to the skin, containing diphenhydramine and benzocaine. It is an approved over‑the‑counter product that has been used for many years and is well documented. It is used to relieve itching, allergic reactions, and minor skin pain or irritation. Diphenhydramine works by blocking histamine receptors that cause itching, while benzocaine numbs the area by blocking nerve signals, and the combination is classified as an antihistamine and a local anesthetic.

Investigated diseases

Systemic lupus erythematosus (SLE) - It is an autoimmune disease in which the immune system mistakenly attacks the body’s own tissues. Inflammation can involve the skin, joints, kidneys, brain, and other organs. Symptoms often appear, improve, and then flare up again. Repeated inflammation may gradually cause damage to the affected organs. The disease typically follows a pattern of active periods followed by quieter phases.