Foralumab Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Foralumab comprises 35 peer-reviewed publications across 15 journals, 0 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Alzheimer Disease, and Multiple System Atrophy. Most recent publication: Glial Activity Load on PET Reveals Persistent "Smoldering" Inflammation in MS Despite Disease-Modifying Treatment: 18 F-PBR06 Study., Clin Nucl Med, 2024.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy.
    Wenning GK, Stankovic I, Vignatelli L, et al. · Mov Disord · 2022
    PubMed: PMID 35445419 · NCT06868628 · Multiple System Atrophy
  2. Glial Activity Load on PET Reveals Persistent "Smoldering" Inflammation in MS Despite Disease-Modifying Treatment: 18 F-PBR06 Study.
    Singhal T, Cicero S, Rissanen E, et al. · Clin Nucl Med · 2024
    PubMed: PMID 38630948 · NCT06868628 · Multiple System Atrophy
  3. Clinical Trial-Ready Patient Cohorts for Multiple System Atrophy: Coupling Biospecimen and iPSC Banking to Longitudinal Deep-Phenotyping.
    Ndayisaba A, Pitaro AT, Willett AS, et al. · Cerebellum · 2024
    PubMed: PMID 36190676 · NCT06868628 · Multiple System Atrophy
  4. Trial of Lixisenatide in Early Parkinson's Disease.
    Meissner WG, Remy P, Giordana C, et al. · N Engl J Med · 2024
    PubMed: PMID 38598572 · NCT06868628 · Multiple System Atrophy
  5. Nasal administration of anti-CD3 monoclonal antibody ameliorates disease in a mouse model of Alzheimer's disease.
    Lopes JR, Zhang X, Mayrink J, et al. · Proc Natl Acad Sci U S A · 2023
    PubMed: PMID 37669383 · NCT06868628 · Multiple System Atrophy
  6. Diagnostic value of skin RT-QuIC in Parkinson's disease: a two-laboratory study.
    Kuzkina A, Bargar C, Schmitt D, et al. · NPJ Parkinsons Dis · 2024
    PubMed: PMID 34782640 · NCT06868628 · Multiple System Atrophy
  7. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes.
    Keymeulen B, Vandemeulebroucke E, Ziegler AG, et al. · N Engl J Med · 2005
    PubMed: PMID 15972866 · NCT06489548 · Alzheimer Disease
  8. Glia Imaging Differentiates Multiple System Atrophy from Parkinson's Disease: A Positron Emission Tomography Study with [11 C]PBR28 and Machine Learning Analysis.
    Jucaite A, Cselényi Z, Kreisl WC, et al. · Mov Disord · 2022
    PubMed: PMID 34609758 · NCT06868628 · Multiple System Atrophy

Publications by year

2004–2024: 35 publications.

2004
1
2005
1
2007
1
2008
2
2009
3
2010
1
2012
2
2014
1
2016
1
2017
5
2018
2
2020
4
2021
3
2022
3
2023
1
2024
4

Publications by indication

Alzheimer Disease (18)

  • PET Imaging of Neuroinflammation in Alzheimer's Disease.
    Front Immunol · 2021 · PMID 34603323 · NCT06489548
  • Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study.
    Front Immunol · 2021 · PMID 34475873 · NCT06489548
  • Restoring regulatory T-cell dysfunction in Alzheimer's disease through ex vivo expansion.
    Brain Commun · 2020 · PMID 32954348 · NCT06489548
  • The Characterization of Regulatory T-Cell Profiles in Alzheimer's Disease and Multiple Sclerosis.
    Sci Rep · 2020 · PMID 31217537 · NCT06489548
  • Microglia Function in the Central Nervous System During Health and Neurodegeneration.
    Annu Rev Immunol · 2018 · PMID 28226226 · NCT06489548

Multiple System Atrophy (17)

  • Glial Activity Load on PET Reveals Persistent "Smoldering" Inflammation in MS Despite Disease-Modifying Treatment: 18 F-PBR06 Study.
    Clin Nucl Med · 2024 · PMID 38630948 · NCT06868628
  • Clinical Trial-Ready Patient Cohorts for Multiple System Atrophy: Coupling Biospecimen and iPSC Banking to Longitudinal Deep-Phenotyping.
    Cerebellum · 2024 · PMID 36190676 · NCT06868628
  • Trial of Lixisenatide in Early Parkinson's Disease.
    N Engl J Med · 2024 · PMID 38598572 · NCT06868628
  • Diagnostic value of skin RT-QuIC in Parkinson's disease: a two-laboratory study.
    NPJ Parkinsons Dis · 2024 · PMID 34782640 · NCT06868628
  • Nasal administration of anti-CD3 monoclonal antibody ameliorates disease in a mouse model of Alzheimer's disease.
    Proc Natl Acad Sci U S A · 2023 · PMID 37669383 · NCT06868628

Publications by journal

All Foralumab publications (35)

2024 (4 papers)

  1. Glial Activity Load on PET Reveals Persistent "Smoldering" Inflammation in MS Despite Disease-Modifying Treatment: 18 F-PBR06 Study.
    Singhal T, Cicero S, Rissanen E, et al. · Clin Nucl Med · 2024 · Background
    PubMed: PMID 38630948 · NCT06868628 · Multiple System Atrophy
  2. Clinical Trial-Ready Patient Cohorts for Multiple System Atrophy: Coupling Biospecimen and iPSC Banking to Longitudinal Deep-Phenotyping.
    Ndayisaba A, Pitaro AT, Willett AS, et al. · Cerebellum · 2024 · Background
    PubMed: PMID 36190676 · NCT06868628 · Multiple System Atrophy
  3. Trial of Lixisenatide in Early Parkinson's Disease.
    Meissner WG, Remy P, Giordana C, et al. · N Engl J Med · 2024 · Background
    PubMed: PMID 38598572 · NCT06868628 · Multiple System Atrophy
  4. Diagnostic value of skin RT-QuIC in Parkinson's disease: a two-laboratory study.
    Kuzkina A, Bargar C, Schmitt D, et al. · NPJ Parkinsons Dis · 2024 · Background
    PubMed: PMID 34782640 · NCT06868628 · Multiple System Atrophy

2023 (1 paper)

  1. Nasal administration of anti-CD3 monoclonal antibody ameliorates disease in a mouse model of Alzheimer's disease.
    Lopes JR, Zhang X, Mayrink J, et al. · Proc Natl Acad Sci U S A · 2023 · Background
    PubMed: PMID 37669383 · NCT06868628 · Multiple System Atrophy

2022 (3 papers)

  1. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy.
    Wenning GK, Stankovic I, Vignatelli L, et al. · Mov Disord · 2022 · Background
    PubMed: PMID 35445419 · NCT06868628 · Multiple System Atrophy
  2. Glia Imaging Differentiates Multiple System Atrophy from Parkinson's Disease: A Positron Emission Tomography Study with [11 C]PBR28 and Machine Learning Analysis.
    Jucaite A, Cselényi Z, Kreisl WC, et al. · Mov Disord · 2022 · Background
    PubMed: PMID 34609758 · NCT06868628 · Multiple System Atrophy
  3. Nasal administration of anti-CD3 monoclonal antibody modulates effector CD8+ T cell function and induces a regulatory response in T cells in human subjects.
    Chitnis T, Kaskow BJ, Case J, et al. · Front Immunol · 2022 · Background
    PubMed: PMID 36505477 · NCT06868628 · Multiple System Atrophy

2021 (3 papers)

  1. PET Imaging of Neuroinflammation in Alzheimer's Disease.
    Zhou R, Ji B, Kong Y, et al. · Front Immunol · 2021 · Background
    PubMed: PMID 34603323 · NCT06489548 · Alzheimer Disease
  2. Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study.
    Moreira TG, Matos KTF, De Paula GS, et al. · Front Immunol · 2021 · Background
    PubMed: PMID 34475873 · NCT06489548 · Alzheimer Disease
  3. Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging.
    Lavisse S, Goutal S, Wimberley C, et al. · Parkinsonism Relat Disord · 2021 · Background
    PubMed: PMID 33242662 · NCT06868628 · Multiple System Atrophy

2020 (4 papers)

  1. Gray matter microglial activation in relapsing vs progressive MS: A [F-18]PBR06-PET study.
    Singhal T, O'Connor K, Dubey S, et al. · Neurol Neuroimmunol Neuroinflamm · 2020 · Background
    PubMed: PMID 31355321 · NCT06868628 · Multiple System Atrophy
  2. Discriminating α-synuclein strains in Parkinson's disease and multiple system atrophy.
    Shahnawaz M, Mukherjee A, Pritzkow S, et al. · Nature · 2020 · Background
    PubMed: PMID 32025029 · NCT06868628 · Multiple System Atrophy
  3. Restoring regulatory T-cell dysfunction in Alzheimer's disease through ex vivo expansion.
    Faridar A, Thome AD, Zhao W, et al. · Brain Commun · 2020 · Background
    PubMed: PMID 32954348 · NCT06489548 · Alzheimer Disease
  4. The Characterization of Regulatory T-Cell Profiles in Alzheimer's Disease and Multiple Sclerosis.
    Ciccocioppo F, Lanuti P, Pierdomenico L, et al. · Sci Rep · 2020 · Background
    PubMed: PMID 31217537 · NCT06489548 · Alzheimer Disease

2018 (2 papers)

  1. Microglia Function in the Central Nervous System During Health and Neurodegeneration.
    Colonna M, Butovsky O · Annu Rev Immunol · 2018 · Background
    PubMed: PMID 28226226 · NCT06489548 · Alzheimer Disease
  2. Neuroprotective effects of CD4+CD25+Foxp3+ regulatory T cells in a 3xTg-AD Alzheimer's disease model.
    Baek H, Ye M, Kang GH, et al. · Oncotarget · 2018 · Background
    PubMed: PMID 27713140 · NCT06489548 · Alzheimer Disease

2017 (5 papers)

  1. Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice.
    Ogura M, Deng S, Preston-Hurlburt P, et al. · Clin Immunol · 2017 · Background
    PubMed: PMID 28739191 · NCT06489548 · Alzheimer Disease
  2. IL-10-dependent Tr1 cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation.
    Mayo L, Cunha AP, Madi A, et al. · Brain · 2017 · Background
    PubMed: PMID 27246324 · NCT06489548 · Alzheimer Disease
  3. Therapeutic anti-CD3 monoclonal antibodies: from bench to bedside.
    Kuhn C, Weiner HL · Immunotherapy · 2017 · Background
    PubMed: PMID 27161438 · NCT06489548 · Alzheimer Disease
  4. The TREM2-APOE Pathway Drives the Transcriptional Phenotype of Dysfunctional Microglia in Neurodegenerative Diseases.
    Krasemann S, Madore C, Cialic R, et al. · Immunity · 2017 · Background
    PubMed: PMID 28930663 · NCT06489548 · Alzheimer Disease
  5. Interleukin-2 improves amyloid pathology, synaptic failure and memory in Alzheimer's disease mice.
    Alves S, Churlaud G, Audrain M, et al. · Brain · 2017 · Background
    PubMed: PMID 28003243 · NCT06489548 · Alzheimer Disease

2016 (1 paper)

  1. Regulatory T cells delay disease progression in Alzheimer-like pathology.
    Dansokho C, Ait Ahmed D, Aid S, et al. · Brain · 2016 · Background
    PubMed: PMID 26912648 · NCT06489548 · Alzheimer Disease

2014 (1 paper)

  1. Identification of a unique TGF-β-dependent molecular and functional signature in microglia.
    Butovsky O, Jedrychowski MP, Moore CS, et al. · Nat Neurosci · 2014 · Background
    PubMed: PMID 24316888 · NCT06489548 · Alzheimer Disease

2012 (2 papers)

  1. MHC-independent genetic factors control the magnitude of CD4+ T cell responses to amyloid-β peptide in mice through regulatory T cell-mediated inhibition.
    Toly-Ndour C, Lui G, Nunes MM, et al. · J Immunol · 2012 · Background
    PubMed: PMID 21949026 · NCT06489548 · Alzheimer Disease
  2. An 18-kDa translocator protein (TSPO) polymorphism explains differences in binding affinity of the PET radioligand PBR28.
    Owen DR, Yeo AJ, Gunn RN, et al. · J Cereb Blood Flow Metab · 2012 · Background
    PubMed: PMID 22008728 · NCT06868628 · Multiple System Atrophy

2010 (1 paper)

  1. Oral administration of OKT3 monoclonal antibody to human subjects induces a dose-dependent immunologic effect in T cells and dendritic cells.
    Ilan Y, Zigmond E, Lalazar G, et al. · J Clin Immunol · 2010 · Background
    PubMed: PMID 19756989 · NCT06489548 · Alzheimer Disease

2009 (3 papers)

  1. Nasal anti-CD3 antibody ameliorates lupus by inducing an IL-10-secreting CD4+ CD25- LAP+ regulatory T cell and is associated with down-regulation of IL-17+ CD4+ ICOS+ CXCR5+ follicular helper T cells.
    Wu HY, Quintana FJ, Weiner HL, et al. · J Immunol · 2009 · Background
    PubMed: PMID 18941193 · NCT06489548 · Alzheimer Disease
  2. Quantification of translocator protein (18 kDa) in the human brain with PET and a novel radioligand, (18)F-PBR06.
    Fujimura Y, Zoghbi SS, Simèon FG, et al. · J Nucl Med · 2009 · Background
    PubMed: PMID 19525468 · NCT06868628 · Multiple System Atrophy
  3. Infiltration of CD4+ lymphocytes into the brain contributes to neurodegeneration in a mouse model of Parkinson disease.
    Brochard V, Combadière B, Prigent A, et al. · J Clin Invest · 2009 · Background
    PubMed: PMID 19104149 · NCT06868628 · Multiple System Atrophy

2008 (2 papers)

  1. Regulatory T cells and immune tolerance.
    Sakaguchi S, Yamaguchi T, Nomura T, et al. · Cell · 2008 · Background
    PubMed: PMID 18510923 · NCT06489548 · Alzheimer Disease
  2. Second consensus statement on the diagnosis of multiple system atrophy.
    Gilman S, Wenning GK, Low PA, et al. · Neurology · 2008 · Background
    PubMed: PMID 18725592 · NCT06868628 · Multiple System Atrophy

2007 (1 paper)

  1. CD3-specific antibodies: a portal to the treatment of autoimmunity.
    Chatenoud L, Bluestone JA · Nat Rev Immunol · 2007 · Background
    PubMed: PMID 17641665 · NCT06868628 · Multiple System Atrophy

2005 (1 paper)

  1. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes.
    Keymeulen B, Vandemeulebroucke E, Ziegler AG, et al. · N Engl J Med · 2005 · Background
    PubMed: PMID 15972866 · NCT06489548 · Alzheimer Disease

2004 (1 paper)

  1. Microglial activation parallels system degeneration in multiple system atrophy.
    Ishizawa K, Komori T, Sasaki S, et al. · J Neuropathol Exp Neurol · 2004 · Background
    PubMed: PMID 14748560 · NCT06868628 · Multiple System Atrophy

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).