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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

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Trial Profile

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: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 May 2025

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At a glance

  • Drugs RLYB 212 (Primary)
  • Indications Haemolytic disease of newborn; Neonatal alloimmune thrombocytopenia
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Rallybio

Most Recent Events

  • 08 May 2025 According to a Rallybio media release, status changed to discontinued based on PK data from the Phase 2 clinical trial demonstrating the inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy.
  • 10 Apr 2025 Status changed from recruiting to active, no longer recruiting.
  • 08 Apr 2025 According to a Rallybio media release, no further enrollment in the trial is planned and all screening of participants has been stopped. The Company will continue safety follow-up of the sentinel participant as specified in the clinical trial protocol.

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