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

Phase 2TerminatedNCT06435845

Rallybio1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Fetal and Neonatal Alloimmune Thrombocytopenia

Interventions

Anti-(integrin beta-3) human monoclonal antibodyDRUG

human monoclonal anti-human platelet antigen (HPA)-1a immunoglobulin G antibody

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (3)

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Oslo University Hospital- Ullevål

Oslo, Oslo County, Norway

Södersjukhuset

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Number of Participants with treatment related adverse events as defined by CTCAE 5.0

Time frame: Approx. Gestational Week (GW) <16, 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38; at birth (~40), Post Partum (PP) Week 4, 10 week

Maternal exposure to RLYB212 as measured in serum

Time frame: Approx. GW 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38, at birth (~40), PP Week 4

Secondary Outcomes

Neonatal exposure to RLYB212 as measured in cord blood

Time frame: At birth (~GW 40)

Number of HPA-1a positive neonates with treatment related adverse events as defined by CTCAE v5.0

Time frame: At birth (~GW 40), Approx. PP Week 4

Anti-RLYB212 antibodies as measured in serum

Time frame: Approx. GW 16, 20, 24, 28, 32, 36, at birth (~40), PP Week 4

Pregnancy Outcomes: incidence of live births, spontaneous abortions, elective abortions, still births or premature births

Time frame: At birth (~GW 40)

Frequency of Neonatal Thrombocytopenia as measured by platelet count within 72 hours of delivery

Time frame: At birth (~GW 40)

Frequency of HPA-1a Alloimmunization as measured by anti-HPA-1a alloantibodies

Time frame: Approx. PP Week 10

Neonatal Outcomes: general health and overall status as defined by absolute values and percentiles

Time frame: 4-6 weeks following delivery

Data from ClinicalTrials.gov

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