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Promising FNAIT prevention study halted early after just one participant

NCT ID NCT06435845

Prevention Sponsor: Rallybio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called RLYB212 in pregnant women at high risk for a condition where the mother's immune system attacks the baby's platelets, causing dangerous bleeding. The goal was to see if the drug was safe and how it moved through the body. Only one woman enrolled before the study was stopped early, so we have very limited information.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Nov 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neonatal thrombocytopenia fetal and neonatal alloimmune thrombocytopenia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fetal and neonatal alloimmune thrombocytopenia

Contacts and locations

Locations

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333, Netherlands

  • Oslo University Hospital- Ullevål

    Oslo, Oslo, 0450, Norway

  • Södersjukhuset

    Stockholm, Stockholm County, 118 83, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.