NCT06435845

Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Rallybio · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.

Detailed description

This study is a single-arm, open-label, multicenter study of RLYB212 in HPA-1b/b pregnant participants at higher risk for the occurrence of HPA-1a alloimmunization and FNAIT. A laboratory testing paradigm will be applied at screening to identify women at higher risk for HPA-1a alloimmunization. Study IPA2202 is comprised of three phases: a two-part screening phase, an antenatal treatment phase, and a postpartum follow-up phase. Study duration for each participant is anticipated to be \~44 weeks, inclusive of the screening visits through the Week 10 postpartum visit.

Conditions

• Fetal and Neonatal Alloimmune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Anti-(integrin beta-3) human monoclonal antibody	human monoclonal anti-human platelet antigen (HPA)-1a immunoglobulin G antibody

Timeline

• Start date: 2024-11-21
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-05-30
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

3 sites across 3 countries: Netherlands, Norway, Sweden

Regulatory

• FDA-regulated drug study