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

NCT ID: NCT06435845

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2026-07-31

Brief Summary

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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

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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

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Fetal and Neonatal Alloimmune Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RLYB212

RLYB212 Subcutaneous injection

Group Type EXPERIMENTAL

Anti-(integrin beta-3) human monoclonal antibody

Intervention Type DRUG

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

Interventions

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Anti-(integrin beta-3) human monoclonal antibody

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

Intervention Type DRUG

Other Intervention Names

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RLYB212

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rallybio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Site Status

Oslo University Hospital- Ullevål

Oslo, Oslo County, Norway

Site Status

Södersjukhuset

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Netherlands Norway Sweden

Other Identifiers

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2024-512651-20-00

Identifier Type: CTIS

Identifier Source: secondary_id

IPA2202

Identifier Type: -

Identifier Source: org_study_id