NCT03272269

Brief Summary

This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2017

Typical duration for phase_1

Geographic Reach
7 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

August 29, 2017

Last Update Submit

September 4, 2019

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus type 1Autoimmune diseaseImmunotherapyDiabetes treatmentResidual beta cell functionAdult patients

Outcome Measures

Primary Outcomes (1)

  • Incidence of all adverse events reported for subjects

    Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests

    up to 24 weeks

Secondary Outcomes (1)

  • Assessment of residual beta cell function and markers of metabolic control

    up to 24 weeks

Other Outcomes (1)

  • Assessment of T lymphocyte immune response to IMCY-0098

    up to 24 weeks

Study Arms (3)

Cohort 1, low dose

EXPERIMENTAL

4 SC injections of IMCY-0098 or Placebo

Drug: IMCY-0098Other: Placebo

Cohort 2, medium dose

EXPERIMENTAL

4 SC injections of IMCY-0098 or Placebo

Drug: IMCY-0098Other: Placebo

Cohort 3, high dose

EXPERIMENTAL

4 SC injections of IMCY-0098 or Placebo

Drug: IMCY-0098Other: Placebo

Interventions

IMCY-0098DRUG

Small synthetic peptide for SC admin. Solvent: alum hydroxide

Also known as: Imotope
Cohort 1, low doseCohort 2, medium doseCohort 3, high dose
PlaceboOTHER

Solvent: alum hydroxide

Cohort 1, low doseCohort 2, medium doseCohort 3, high dose

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female 18 to 30 years of age
  • Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
  • Insulin requirement, as determined by the investigator
  • Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
  • Fasting C-peptide at screening \>0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
  • HLADR3-positive and/or HLADR4-positive
  • Willingness to undergo the insulin treatment prescribed by the physician
  • Body mass index (BMI) between 17-28 kg/m2 at screening
  • Fully informed written consent obtained
  • Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.
  • Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.

You may not qualify if:

  • Ongoing or planned pregnancy during the whole duration of the study or lactation
  • Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .
  • Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
  • Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin \[BCG\] vaccine, oral typhoid vaccine)
  • History of, or current malignancy (except excised basal cell skin cancer)
  • Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
  • Primary or secondary immune deficiency disorders
  • Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
  • Anti-diabetic treatments other than insulin in the week prior to first study drug administration
  • Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
  • Treatment with immunotherapy within the past 3 months
  • Treatment with an investigational drug within the past 3 months
  • Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
  • Patients under treatment with statins at the time of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hôpital Erasme

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Bispebjerg and Frederiksberg Hospital

Copenhagen, Denmark

Location

CHU de Nantes, Hôpital Laennec

Nantes, France

Location

GWT-TUD GmbH

Dresden, Germany

Location

Klaipeda University Hospital

Klaipėda, Lithuania

Location

University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

Clinical Trial Center, CTC

Gothenburg, Sweden

Location

ProbarE Stockholm

Stockholm, Sweden

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Cardiff University

Cardiff, United Kingdom

Location

Royal Devon and Exeter NHS Trust

Exeter, United Kingdom

Location

Guy's and St. Thomas NHS Trust

London, United Kingdom

Location

St. Bartholomew's Hospital (Barts Health NHS Trust)

London, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (5)

  • Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.

    PMID: 23056200BACKGROUND

  • Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.

    PMID: 26388872BACKGROUND

  • Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016.

    PMID: 26973647BACKGROUND

  • Van Rampelbergh J, Achenbach P, Leslie RD, Kindermans M, Parmentier F, Carlier V, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. 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. BMC Med. 2024 Jun 21;22(1):259. doi: 10.1186/s12916-024-03476-y.

    PMID: 38902652DERIVED

  • Van Rampelbergh J, Achenbach P, Leslie RD, Ali MA, Dayan C, Keymeulen B, Owen KR, Kindermans M, Parmentier F, Carlier V, Ahangarani RR, Gebruers E, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes. BMC Med. 2023 May 24;21(1):190. doi: 10.1186/s12916-023-02900-z.

    PMID: 37226224DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Study Officials

  • Pierre Vandepapelière, MD

    Imcyse SA

    STUDY DIRECTOR

  • Christian Boitard, MD

    Hôpital Cochin, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double-blind, placebo controlled
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 5, 2017

Study Start

August 23, 2017

Primary Completion

April 17, 2019

Study Completion

August 30, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)LI(2)SE(2)FR(1)GB(7)BE(3)DK(1)