Safety and tolerability of rinvecalinase alfa in pregnant women with preterm preeclampsia undergoing expectant management
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study focuses on preterm preeclampsia, a condition that can develop during pregnancy and cause high blood pressure and organ problems before the baby is fully grown. The medication being tested is identified by the code name DM199, which is given as a liquid injection under the skin. The main goal of the research is to see if the medicine is safe for both the pregnant person and the baby and to understand how the drug moves through the body and into the baby’s circulation and later into breast milk.
Participants who have been diagnosed with the condition between 24 and 33 weeks of pregnancy and are being watched closely without delivering the baby early will receive a series of low to higher doses of the injection. After each dose, blood samples from the mother, the baby’s umbilical cord at birth, and any breast milk collected later will be checked to measure the amount of drug present. The study also records any side effects, changes in blood pressure, and how many days the pregnancy continues after treatment begins before delivery occurs.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- Be pregnant with a single baby (not twins) between 24 weeks and 33 weeks of pregnancy and have a living (viable) fetus.
- Be 18 years of age or older and able to understand and sign a consent form.
- Have a diagnosis of pre‑eclampsia (PE) or superimposed PE, which means new high blood pressure after 20 weeks (blood pressure ≥ 140/90 mmHg) together with significant protein in the urine (proteinuria ≥ 0.3 g/dL in a 24‑hour collection or a spot urine ratio ≥ 30 mg/mmol).
- If you have chronic kidney disease stage 1‑3 without chronic high blood pressure, you must develop new high blood pressure and at least double the amount of protein in the urine compared with your baseline.
- Be eligible for expectant management (watchful waiting) for more than 48 hours.
- Weigh between 50 kg and 130 kg at the screening visit.
- Agree to be admitted to the hospital for inpatient expectant management of pre‑term PE until delivery.
- Be willing and able to follow all study procedures as judged by the investigator.
Who cannot join the trial?
17 criteria
- Severe complications of preeclampsia that need an immediate delivery, such as eclampsia (seizures or coma during pregnancy), pulmonary edema (fluid buildup in the lungs causing low oxygen), HELLP syndrome (blood‑cell breakdown, high liver enzymes, and low platelets), severe kidney problems, stroke, a headache that does not get better with pain medicine, ongoing vision problems, a liver bleed or rupture, or blood pressure that cannot be controlled even with strong medicines.
- Having a known α₁‑antitrypsin deficiency or a known inherited condition called hereditary angioedema, which can cause dangerous swelling.
- Being in another experimental study or having taken an experimental drug or device within the last 90 days or during the current pregnancy.
- Having an active cancer or a past history of cancer, except for the very common skin cancers called squamous cell carcinoma or basal cell carcinoma.
- Having a substance use disorder (problematic use of alcohol or drugs) that could affect safety or the ability to follow the study plan.
- Being unable or unwilling to follow the study requirements, such as attending visits, completing tests, and following procedures.
- Any medical condition that the doctor believes creates too much risk or would interfere with the study’s results.
- Having no blood flow or reversed blood flow in the umbilical artery, which supplies the baby.
- Being suspected of or diagnosed with a major fetal abnormality, serious birth defect, or chromosome problem.
- Having a placental abruption (the placenta separates from the uterus before birth) or having experienced a stillbirth.
- Fetal distress that requires an urgent delivery.
- Having advanced chronic kidney disease (stage 4‑5) with an estimated filtration rate below 30 mL/min/1.73 m², or needing dialysis.
- Having uncontrolled thyroid disease despite medication.
- Having significant heart disease, such as serious rhythm problems, major valve issues, or other heart conditions that increase risk.
- Having significant vascular disease, for example narrowing of the kidney arteries.
- Having a history of serious allergic reactions (like angioedema or anaphylaxis that required hospitalization) or a known allergy to the study drug DM199.
- Having an active infection that requires intravenous antibiotics or hospital monitoring at the time of enrollment (for example, chorioamnionitis). Simple infections treated with oral antibiotics are not a reason to be excluded.
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Investigated drugs
RINVECALINASE ALFA is an experimental medication being studied to help pregnant women who develop preterm preeclampsia. It is given as a small injection under the skin (subcutaneous) in a liquid form. In this trial the drug is tested to see if it is safe and well‑tolerated for both the mother and the baby, and to understand how it moves through the mother's blood, the baby's circulation (through cord blood), and later into breast milk or colostrum after birth.
What is already known about the treatment
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
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