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Study on the Safety and Effects of RLYB212 in Pregnant Women at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

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What is this trial about?

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

This clinical trial is focused on studying a condition known as Fetal and Neonatal Alloimmune Thrombocytopenia, which occurs due to incompatibility between the mother's and baby's platelets, specifically involving a protein called Human Platelet Antigen 1. The study is investigating a treatment called RLYB212, which is a type of medication known as a human monoclonal antibody. This medication is designed to target a specific protein in the body called integrin beta-3, and it is administered as a solution through a subcutaneous injection, meaning it is injected under the skin.

The purpose of this study is to understand how RLYB212 behaves in the body during pregnancy and to ensure it is safe for both the mother and the baby. Pregnant women who are at a higher risk for this condition will receive the medication multiple times during their pregnancy. The study will monitor how the medication is processed in the body and will check for any side effects in both the mother and the baby. This includes regular physical examinations, checking vital signs, and using ultrasound to monitor the baby's health.

The study will also look at the presence of the medication in the baby's blood at birth and will track the health and development of the baby for a few weeks after birth. Additionally, researchers will observe if the mother develops any antibodies against the medication, which could affect its effectiveness. The study aims to provide valuable information on the safety and effectiveness of RLYB212 for preventing complications related to Fetal and Neonatal Alloimmune Thrombocytopenia during pregnancy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants are pregnant women between 18-45 years of age, presenting at gestational week 6 or later, with specific genetic markers and carrying a fetus with a particular antigen.
Step 2
Initial assessment
An initial assessment is conducted, including a physical examination, vital signs check, and laboratory tests. This helps establish a baseline for monitoring throughout the study.
Step 3
Medication administration
The medication, RLYB212, is administered as a subcutaneous injection. This is a solution for injection given under the skin. The frequency and dosage are determined by the study protocol and are repeated throughout the pregnancy.
Step 4
Ongoing monitoring
Regular monitoring is conducted to assess the pharmacokinetics of RLYB212, which includes measuring how the drug is absorbed, distributed, and eliminated in the body. This involves checking the concentration of the drug in the blood at various times.
Safety assessments are also performed, including physical examinations, vital signs, and laboratory tests. An ECG and obstetric/fetal ultrasound may be conducted to ensure maternal and fetal well-being.
Step 5
Delivery and post-delivery assessment
At delivery, the concentration of RLYB212 in the cord blood is measured. The health of the newborn is assessed, including an APGAR score, which evaluates the baby's condition immediately after birth.
The presence of any adverse effects in the mother or newborn is recorded. The development of anti-drug antibodies is also monitored.
Step 6
Follow-up
Follow-up assessments are conducted up to 4-6 weeks after birth to monitor the health and development of the infant. The presence of maternal anti-HPA-1a alloantibodies is checked at week 10 post-pregnancy.

Who can join the trial?

6 criteria

Must be a pregnant woman who is at least in the 6th week of pregnancy.
Must be between 18 and 45 years old.
Must have a specific blood type called HPA-1b/b, which means they do not have the HPA-1a marker.
Must have a specific genetic marker called HLA-DRB3*01:01.
Must not have antibodies against the HPA-1a marker, known as Anti-HPA-1a alloantibody negative.
Must be carrying a baby with a specific blood type called HPA-1a/b, which means the baby has the HPA-1a marker.

Who cannot join the trial?

9 criteria

Individuals who are not pregnant cannot participate.
Men are not eligible to join the study.
Participants must not have any other medical conditions that could interfere with the study.
Participants should not have any allergies or reactions to the study medication.
Individuals who are unable to follow the study procedures or attend all required visits cannot participate.
Participants must not be involved in another clinical trial at the same time.
Individuals with a history of drug or alcohol abuse may be excluded.
Participants should not have any serious health issues that could affect their safety during the study.
Individuals who are unable to give informed consent cannot participate.

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Verified sites

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Soedersjukhuset AB
Stockholm, Sweden

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Investigated drugs

RLYB212 is a medication being studied for its effects and safety in pregnant women who are at higher risk for a condition called HPA-1a alloimmunization. This condition can occur when a pregnant woman's immune system reacts against certain proteins on her baby's blood cells. The study aims to understand how RLYB212 is processed in the body during pregnancy and to ensure it is safe for both the mother and the baby.

Anti-(Integrin Beta-3) Human Monoclonal Antibody

What is already known about the treatment

RLYB212 – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials, specifically in a Phase 2 study, to understand its pharmacokinetics and safety in pregnant women at risk for alloimmunization due to Human Platelet Antigen 1 incompatibility. The main therapeutic indication for RLYB212 is to prevent fetal and neonatal alloimmune thrombocytopenia, a condition where the mother's immune system attacks the baby's platelets. At the molecular level, RLYB212 works by targeting specific antigens to prevent the immune response that leads to platelet destruction. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Fetal and Neonatal Alloimmune Thrombocytopenia due to Human Platelet Antigen 1 incompatibility – This condition occurs when a pregnant woman's immune system attacks the platelets of her fetus, mistaking them for foreign due to differences in platelet antigens. Specifically, it involves an incompatibility between the mother's and the fetus's Human Platelet Antigen 1 (HPA-1). The mother's immune system produces antibodies against the fetal platelets, leading to their destruction. This can result in low platelet counts in the fetus or newborn, known as thrombocytopenia. The condition can cause bleeding issues in the fetus or newborn due to the reduced ability of the blood to clot. It is a rare condition and is typically identified during pregnancy or shortly after birth.