Evidence map›Paper›PMID 39168139›Full record

Trial reportThrombosis and haemostasis2025

A Phase 1b PK/PD Study to Demonstrate Antigen Elimination with RLYB212, A Monoclonal Anti-HPA-1a Antibody for FNAIT Prevention.

Christof Geisen, Erika Fleck, Stephan Martin Gastón Schäfer, Carmen Walter, Susanne Braeuninger, Jens Søndergaard Jensen, Douglas Sheridan, Kiran Patki, Róisín Armstrong, Bjørn Skogen and 5 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Thrombosis and haemostasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Christof GeisenInstitute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen GmbH, Frankfurt am Main, Germany.
Erika FleckInstitute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen GmbH, Frankfurt am Main, Germany.
Stephan Martin Gastón SchäferDivision Clinical Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany.
Carmen WalterDivision Clinical Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany.
Susanne BraeuningerInstitute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen GmbH, Frankfurt am Main, Germany.
Jens Søndergaard JensenAixial Danmark A/S, Herlev, Denmark.
Douglas SheridanRallybio, New Haven, Connecticut, United States.
Kiran PatkiRallybio, New Haven, Connecticut, United States.
Róisín ArmstrongRallybio, New Haven, Connecticut, United States.
Bjørn SkogenDepartment of Laboratory Medicine, University Hospital of North Norway, Tromsø, Norway.
Frank BehrensDivision Clinical Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany.
Erhard SeifriedInstitute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen GmbH, Frankfurt am Main, Germany.
Jens Kjeldsen-KraghDepartment of Laboratory Medicine, University Hospital of North Norway, Tromsø, Norway.ORCID 0000-0003-2901-242X
Mette KjærFaculty of Health Sciences, UiT-The Arctic University of Norway, Hammerfest, Norway.
Michaela KöhmDivision Clinical Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a rare bleeding disorder of the fetus/newborn caused by development of maternal alloantibodies against fetal human platelet antigens (HPAs), predominantly HPA-1a. Currently there are no treatments available to prevent maternal alloimmunization to HPAs or FNAIT.This proof-of-concept study (EudraCT Number: 2021-005380-49) was designed to assess the ability of subcutaneous (SC) RLYB212, a monoclonal anti-HPA-1a antibody, to eliminate HPA-1a-positive platelets in an antigen challenge model of a 30 mL fetal-maternal hemorrhage. Subjects were randomized to receive a single SC dose of RLYB212 or placebo on day 1 in a single-blinded manner, followed by transfusion of 10 × 10

Indexed as

Antibodies, MonoclonalAntigens, Human PlateletIntegrin beta3Thrombocytopenia, Neonatal AlloimmuneAdultBlood PlateletsFemaleHumansInfant, NewbornIsoantibodiesMalePlatelet TransfusionPregnancyProof of Concept StudySingle-Blind MethodYoung AdultAntibodies, MonoclonalAntigens, Human PlateletIntegrin beta3IsoantibodiesITGB3 protein, human

Identifiers

PMID39168139
PMCPMC11961231

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.