Ongoing Clinical Trials for Neonatal Alloimmune Thrombocytopenia
Currently, there are 3 ongoing clinical trials investigating new treatments for neonatal alloimmune thrombocytopenia. These studies are being conducted across multiple European countries and are testing medications designed to protect babies from immune-related platelet problems during pregnancy. The trials focus on preventing severe bleeding complications in at-risk pregnancies by using innovative immunotherapy approaches.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Slovakia
- Slovenia
- Spain
- Sweden
Study of Nipocalimab or IVIG for Pregnant Women at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
This study is comparing two different treatments to help protect babies from a rare condition where the mother’s immune system attacks the baby’s platelets during pregnancy. The two treatments being tested are nipocalimab, a newer protein-based medication, and IVIG (intravenous immunoglobulin), which is already used in medical practice. Both are given through an infusion into a vein.
Who can participate: The study is looking for pregnant women who are at least 18 years old and between 13 to 16 weeks of pregnancy. Participants must have specific antibodies in their blood (anti-HPA-1a and/or anti-HPA-5b) and their baby must test positive for certain genetic markers (HPA-1a and/or HPA-5b). Women need to be in stable health as confirmed by physical examination, medical history, vital signs, heart tests, and laboratory work.
Who cannot participate: Only women can join this study. Participants must be within the specified age range and cannot be part of a vulnerable population that might need special care or protection.
What the study involves: Participants will be randomly assigned to receive either nipocalimab or IVIG through regular intravenous infusions throughout their pregnancy. The treatment period lasts up to 29 weeks for nipocalimab and up to 30 weeks for IVIG. Regular follow-up visits will include physical examinations, blood tests, and monitoring of both mother and baby. After birth, the newborn will be checked for any bleeding issues or low platelet counts.
Study medications: Nipocalimab works by blocking specific immune system proteins to prevent the mother’s immune system from attacking the baby’s platelets. IVIG provides a mixture of antibodies that help protect the baby from the mother’s immune response. Both aim to reduce the risk of severe bleeding complications in the baby.
Study on Nipocalimab for Reducing Risk of Fetal and Neonatal Alloimmune Thrombocytopenia in At-risk Pregnancies
This trial is testing whether nipocalimab is more effective than a placebo (inactive substance) in reducing the risk of severe complications from the condition. The study is conducted in a double-blind manner, meaning neither participants nor researchers know who receives the actual medication or placebo until the study ends.
Who can participate: Women must be at least 18 years old and pregnant between 13 to 16 weeks gestation. They must have had at least one previous pregnancy affected by this condition, but without severe bleeding in the baby. In the current pregnancy, they must have the anti-HPA-1a antibody, and their baby must test positive for HPA-1a. Participants need to be in stable health confirmed by physical examination, medical history, vital signs, ECG, and laboratory tests.
Who cannot participate: Only females within the specified age range can participate. Those outside the study’s target population cannot join.
What the study involves: After an initial health assessment, participants are randomly assigned to receive either nipocalimab or placebo through intravenous infusion. Regular monitoring throughout pregnancy includes physical exams, blood tests, and other evaluations. The study follows both mother and baby closely through delivery and monitors the newborn’s health during the first week after birth, checking platelet levels and watching for any bleeding issues.
Study medication: Nipocalimab is a monoclonal antibody designed to block certain immune responses that contribute to the condition. It works at the molecular level to prevent the mother’s immune system from destroying the baby’s platelets, potentially making pregnancy safer for at-risk mothers and their babies.
Study on the Safety and Effects of RLYB212 in Pregnant Women at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
This study is investigating RLYB212, a human monoclonal antibody that targets a specific protein called integrin beta-3. Unlike the other trials, this medication is given as an injection under the skin rather than through an intravenous infusion. The focus is on understanding how the medication behaves in the body during pregnancy and ensuring it is safe for both mother and baby.
Who can participate: Pregnant women between 18 and 45 years old who are at least in their 6th week of pregnancy can join. They must have a specific blood type (HPA-1b/b) and genetic marker (HLA-DRB3*01:01), and they must not yet have developed antibodies against HPA-1a. Their baby must have the HPA-1a/b blood type.
Who cannot participate: Men and non-pregnant individuals cannot participate. Those with other medical conditions that could interfere with the study, allergies to the study medication, or serious health issues affecting safety are excluded. Participants must be able to follow study procedures, attend all visits, give informed consent, and not be involved in another clinical trial. Those with a history of drug or alcohol abuse may also be excluded.
What the study involves: After confirming eligibility and conducting baseline assessments, participants receive RLYB212 as subcutaneous injections (under the skin) multiple times during pregnancy. Regular monitoring tracks how the medication is absorbed and eliminated from the body, and includes physical examinations, vital signs, laboratory tests, ECGs, and ultrasounds to check fetal health. At delivery, the medication level is measured in cord blood, and the newborn’s health is assessed. Follow-up continues for 4-6 weeks after birth to monitor infant development.
Study medication: RLYB212 is an immunomodulatory agent being studied in Phase 2 trials. It targets specific antigens to prevent the immune response that leads to platelet destruction. By addressing the underlying mechanism, it aims to prevent the condition from developing in at-risk pregnancies.
Summary
All three ongoing clinical trials are focused on preventing neonatal alloimmune thrombocytopenia during pregnancy using innovative immunotherapy approaches. Two trials are testing nipocalimab, with one comparing it to the established treatment IVIG and another testing it against placebo. The third trial is investigating RLYB212, a different type of monoclonal antibody with a unique mechanism of action.
These studies are being conducted across 13 European countries, with the broadest geographic coverage in Belgium, Germany, Netherlands, Norway, and Sweden, where multiple trials are available. This geographic distribution provides opportunities for pregnant women at risk across Europe to access experimental treatments that may help protect their babies.
The trials share similar inclusion criteria, focusing on pregnant women in early to mid-pregnancy who either have a history of the condition or carry specific genetic markers and antibodies that put their current pregnancy at risk. All three studies emphasize careful monitoring of both maternal and fetal health throughout pregnancy and after delivery, reflecting the serious nature of the condition being studied.
