drugset / Trial / NCT06435845

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

NCT06435845 ↗

Phase 2 Terminated 1 enrolled Rallybio
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2024-11-21
Primary completion
2025-10-01
Completion
2025-10-01

Outcome

Outcome not reported

Stopped: “This study was terminated early by the sponsor due to insufficient drug exposure to achieve the intended therapeutic effect.”

Drugs

EvaluationDrugModalityDoseRoute
Subject RLYB212 Monoclonal antibody — Subcutaneous