A PK/Safety Study of RLYB212 in Pregnant Women at Higher Risk of FNAIT
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
IRAS ID
1009907
Contact name
Jackie Schumacher
Contact email
Sponsor organisation
Rallybio IPA, LLC
Clinicaltrials.gov Identifier
Research summary
Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a rare and potentially dangerous disorder that can cause severe bleeding in the unborn and newborn baby. An unborn or newborn baby with a low platelet count can have severe bleeding problems which can in rare cases lead to brain damage or death. Currently, there are no treatments to prevent this condition in pregnant women at risk.
The purpose of this research study, called IPA2202, is to see if RLYB212 is safe and how the body processes and responds to it among pregnant women at higher risk for HPA-1a alloimmunisation.
The study is comprised of three phases:
• A two-part screening phase (Screening Part 1 and Screening Part 2)
• An treatment phase during pregnancy
• An after delivery follow-up phase.
Participants who are not eligible to receive the study drug or decide not to participate, may be invited to enter a research study where they will be observed throughout their pregnancy.
The total study duration for you is approximately 44 weeks. Participants may undergo the following procedures: Physical examination, vital signs (blood pressures, heart rate, and body temperature), electrocardiogram (to check the heart), ultrasound scan, blood and urine samples and subcutaneous injection (under your skin) of study drug.
Approximately 5000 pregnant women globally will be screened to identify 8 higher risk pregnancies for this study.
Rallybio IPA, LLC is the Sponsor for this study and is based in the United States.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0225
Date of REC Opinion
20 Sep 2024
REC opinion
Further Information Favourable Opinion