NCT06435845Phase 2Terminated

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

Study sponsor: Rallybio

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-10-01Actual

Enrollment · participants1Actual

Source updated2026-03-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-01-30 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Number of Participants ~~with~~ ~~treatment~~ ~~related~~ ~~adverse~~ ~~events~~ as ~~defined~~ by CTCAE 5.0 Measure: Maternal ~~exposure~~ to RLYB212 as ~~measured~~ in ~~serum~~

+ After

Measure: Number of Participants With Treatment Related Adverse Events as Defined by CTCAE 5.0 Measure: Maternal Exposure to RLYB212 as Measured in Serum

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Posted 2026-01-13 · 1 field changed

Recruitment status changed

− Before

~~Completed~~

+ After

Terminated

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Posted 2026-01-09 · 3 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~8 participants (planned)~~

+ After

1 participants (actual)

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

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Posted 2025-11-06 · 2 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~May 2027~~

+ After

1 Oct 2025

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Study details

Conditions studied

Fetal and Neonatal Alloimmune Thrombocytopenia

Treatments or interventions studied

Anti-(integrin beta-3) human monoclonal antibodyDrugAlso known as RLYB212

Primary outcomes · main study measures

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measure: Number of Participants With Treatment Related Adverse Events as Defined by CTCAE 5.0; description: Adverse Events will be collected throughout the study from the time of screening part 2 and beyond until the end of study visit (10 weeks postpartum for the maternal participant and 4-6 weeks of age for the neonate/infant). MedDRA version 27.0 or above will be used to code the AEs. All maternal AEs will be graded according to the National Cancer Institute of Common Terminology Criteria for AEs (CTCAE version 5.0 or higher) and Maternal and Fetal Adverse Event Terminology (MFAET version 1.0 or higher).; timeFrame: 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; measure: Maternal Exposure to RLYB212 as Measured in Serum; description: The PK profile of RLYB212 during pregnancy following repeat SC administration was evaluated. Results reported in concentration only.; timeFrame: Approx. GW 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38, at birth (~40), PP Week 4

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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