Evidence map›Paper›PMID 38902652›Full record

Trial reportBMC medicine2024

First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers.

Jean Van Rampelbergh, Peter Achenbach, Richard David Leslie, Martin Kindermans, Frédéric Parmentier, Vincent Carlier, Nicolas Bovy, Luc Vanderelst, Marcelle Van Mechelen, Pierre Vandepapelière and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03272269 (A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT03272269 phase1completednot on this map

A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

TypeinterventionalSponsorImcyse SARan2017 to 2019Enrolled41ConditionsType 1 Diabetes MellitusArmsIMCY-0098, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Trial
  2. Review
  3. Observational
  4. Review
  5. Article
  6. Review
  7. Review
  8. Vaccines · 2025
    Review
  9. Review
  10. Review
  11. Review
  12. 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

11 authors.

Jean Van Rampelbergh *Imcyse S.A, Avenue Pré-Aily 14, Liège, 4031, Belgium. j.vanrampelbergh@imcyse.com.
Peter Achenbach *Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.
Richard David Leslie *Department of Immunobiology, Queen Mary University of London, London, UK.
Martin KindermansAriana Pharmaceuticals SA, Paris, France.
Frédéric ParmentierAriana Pharmaceuticals SA, Paris, France.
Vincent CarlierImcyse S.A, Avenue Pré-Aily 14, Liège, 4031, Belgium.
Nicolas BovyImcyse S.A, Avenue Pré-Aily 14, Liège, 4031, Belgium.
Luc VanderelstImcyse S.A, Avenue Pré-Aily 14, Liège, 4031, Belgium.
Marcelle Van MechelenImcyse S.A, Avenue Pré-Aily 14, Liège, 4031, Belgium.
Pierre Vandepapelière *Imcyse S.A, Avenue Pré-Aily 14, Liège, 4031, Belgium.
Christian Boitard *Inserm U1016, Cochin Institute, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIMCY-0098, a synthetic peptide developed to halt disease progression via elimination of key immune cells in the autoimmune cascade, has shown a promising safety profile for the treatment of type 1 diabetes (T1D) in a recent phase 1b trial. This exploratory analysis of data from that trial aimed to identify the patient biomarkers at baseline associated with a positive response to treatment and examined the associations between immune response parameters and clinical efficacy endpoints (as surrogates for mechanism of action endpoints) using an artificial intelligence-based approach of unsupervised explainable machine learning.

methodsWe conducted an exploratory analysis of data from a phase 1b, dose-escalation, randomized, placebo-controlled study of IMCY-0098 in patients with recent-onset T1D. Here, a panel of markers of T cell activation, memory T cells, and effector T cell response were analyzed via descriptive statistics. Artificial intelligence-based analyses of associations between all variables, including immune responses and clinical responses, were performed using the Knowledge Extraction and Management (KEM

resultsThe relationship between all available patient data was investigated using unsupervised machine learning implemented in the KEM

conclusionsPromising preliminary efficacy results support the design of a phase 2 study of IMCY-0098 in patients with recent-onset T1D.

trial registrationClinicalTrials.gov NCT03272269; EudraCT: 2016-003514-27.

Indexed as

BiomarkersDiabetes Mellitus, Type 1AdolescentAdultDouble-Blind MethodFemaleHumansImmunotherapyMaleMiddle AgedPeptidesTreatment OutcomeYoung AdultBiomarkersPeptidesBeta cellsExploratory analysisImmune biomarker machine learningImmunotherapyT cellsType 1 diabetes

Identifiers

PMID38902652
PMCPMC11191262

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.