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

Fetal and Neonatal Alloimmune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435845
• Other study ID #: IPA2202
• Secondary ID: 2024-512651-20-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Rallybio IPA, LLC
• Contact: Chief Medical Officer
• Phone: 2038593820
• Email: clinicaltrials[@]rallybio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal and Neonatal Alloimmune Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• Anti-(integrin beta-3) human monoclonal antibody
human monoclonal anti-human platelet antigen (HPA)-1a immunoglobulin G antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rallybio IPA, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Neonatal exposure to RLYB212 as measured in cord blood		At birth (~GW 40)
Secondary	Number of HPA-1a positive neonates with treatment related adverse events as defined by CTCAE v5.0		At birth (~GW 40), Approx. PP Week 4
Secondary	Anti-RLYB212 antibodies as measured in serum		Approx. GW 16, 20, 24, 28, 32, 36, at birth (~40), PP Week 4
Secondary	Pregnancy Outcomes: incidence of live births, spontaneous abortions, elective abortions, still births or premature births		At birth (~GW 40)
Secondary	Frequency of Neonatal Thrombocytopenia as measured by platelet count within 72 hours of delivery		At birth (~GW 40)
Secondary	Frequency of HPA-1a Alloimmunization as measured by anti-HPA-1a alloantibodies		Approx. PP Week 10
Secondary	Neonatal Outcomes: general health and overall status as defined by absolute values and percentiles		4-6 weeks following delivery