Clinical trial
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
Name
IPA2202
Description
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.
Trial arms
Trial start
2024-09-01
Estimated PCD
2027-05-01
Trial end
2027-05-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Anti-(integrin beta-3) human monoclonal antibody
human monoclonal anti-human platelet antigen (HPA)-1a immunoglobulin G antibody
Arms:
RLYB212
Other names:
RLYB212
Size
8
Primary endpoint
Number of Participants with treatment related adverse events as defined by CTCAE 5.0
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
Approx. GW 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38, at birth (~40), PP Week 4
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}
Updated at
2024-05-30
1 organization
1 product
1 indication
Organization
Rallybio IPA