Evidence map›Paper›PMID 39552477›Full record

Trial reportBritish journal of haematology2025

Inhibition of FcRn with rozanolixizumab in adults with immune thrombocytopenia: Two randomised, double-blind, placebo-controlled phase 3 studies and their open-label extension.

Nichola Cooper, James B Bussel, Maciej Kaźmierczak, Yoshitaka Miyakawa, Sarah Cluck, Rocío Lledó García, Birgit Haier, Andreea Lavrov, Puneet Singh, Rose Snipes and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04200456 (A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT04200456 phase3terminatednot on this map

A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

TypeinterventionalSponsorUCB Biopharma SRLRan2020 to 2022Enrolled33ConditionsPrimary Immune ThrombocytopeniaArmsRozanolixizumab, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Polypharmacology of S-1117, an Fc-fused IgG-selective degrading enzyme, for chronic treatment of autoantibody-mediated diseases.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  5. Review
  6. Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  7. Article
  8. Review
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

11 authors.

Nichola CooperImperial College London, London, UK.ORCID https://orcid.org/0000-0002-9845-8292
James B BusselWeill Cornell Medicine - New York Presbyterian Hospital, New York, New York, USA.ORCID https://orcid.org/0000-0002-2884-9247
Maciej KaźmierczakPoznań University of Medical Sciences, Poznań, Poland.
Yoshitaka MiyakawaSaitama Medical University, Saitama, Japan.
Sarah CluckUCB, Slough, UK.
Rocío Lledó GarcíaUCB, Slough, UK.
Birgit HaierUCB, Monheim, Germany.
Andreea LavrovUCB, Monheim, Germany.
Puneet SinghUCB, Slough, UK.
Rose SnipesUCB, Morrisville, North Carolina, USA.
David J KuterHematology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-2084-8810

Funding

UCB Pharma
6 · The paper itself

Abstract

Primary immune thrombocytopenia (ITP) is an antiplatelet-antibody-mediated disorder with accelerated platelet clearance and decreased platelet production. Rozanolixizumab, a monoclonal IgG4 anti-FcRn antibody, blocks IgG recycling and decreases IgG levels. We report efficacy and safety of rozanolixizumab in adults with persistent/chronic ITP in 24-week phase 3 studies (TP0003; TP0006), and their 52-week open-label extension (OLE). Primary end-point was durable clinically meaningful platelet response (DCMPR) of ≥50 × 10

Indexed as

Antibodies, Monoclonal, HumanizedHistocompatibility Antigens Class IPurpura, Thrombocytopenic, IdiopathicReceptors, FcAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedPlatelet CountTreatment OutcomeAntibodies, Monoclonal, HumanizedFc receptor, neonatalHistocompatibility Antigens Class IReceptors, Fcclinical trialFcRnimmune thrombocytopeniaimmunoglobulin Gopen‐label extensionrozanolixizumab

Identifiers

PMID39552477
PMCPMC11829145

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.