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

Rallybio

Status and phase: Active, not recruiting; Phase 2

Conditions: Fetal and Neonatal Alloimmune Thrombocytopenia

Treatments: Drug: Anti-(integrin beta-3) human monoclonal antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT06435845

IPA2202

2024-512651-20-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Pregnant women who present at Gestational Week 6 or after and confirmed to be: HPA-1b/b (HPA-1a negative), HLA-DRB3*01:01 positive, Anti-HPA-1a alloantibody negative, Carrying an HPA-1a/b (HPA-1a positive) fetus

Exclusion criteria

• Prior history of HPA-1a related fetal and neonatal alloimmune thrombocytopenia
• Multiple pregnancy (more than 1 fetus)
• Prior history of platelet transfusion or other blood transfusions
• Known sensitivity and/or immediate hypersensitivity to any components of RLYB212 or its formulation
• Any co-morbid medical or obstetric condition(s), laboratory abnormality, concomitant treatment, or other reason that, in the investigator's opinion, could adversely affect the safety of the participant and/or fetus, impair the assessment of study results, or preclude compliance with the study

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

RLYB212

Experimental group

Description:

RLYB212 Subcutaneous injection

Treatment:

Drug: Anti-(integrin beta-3) human monoclonal antibody