Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
NCT ID: NCT03272269
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2017-08-23
2019-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Cohort 1, low dose
4 SC injections of IMCY-0098 or Placebo
IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Placebo
Solvent: alum hydroxide
Cohort 2, medium dose
4 SC injections of IMCY-0098 or Placebo
IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Placebo
Solvent: alum hydroxide
Cohort 3, high dose
4 SC injections of IMCY-0098 or Placebo
IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Placebo
Solvent: alum hydroxide
Interventions
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IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Placebo
Solvent: alum hydroxide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
3. Insulin requirement, as determined by the investigator
4. Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
5. Fasting C-peptide at screening \>0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
6. HLADR3-positive and/or HLADR4-positive
7. Willingness to undergo the insulin treatment prescribed by the physician
8. Body mass index (BMI) between 17-28 kg/m2 at screening
9. Fully informed written consent obtained
10. Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.
11. Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.
Exclusion Criteria
2. 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 .
3. 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
4. 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)
5. History of, or current malignancy (except excised basal cell skin cancer)
6. Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
7. Primary or secondary immune deficiency disorders
8. Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
9. Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
10. Anti-diabetic treatments other than insulin in the week prior to first study drug administration
11. Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
12. Treatment with immunotherapy within the past 3 months
13. Treatment with an investigational drug within the past 3 months
14. Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
15. Patients under treatment with statins at the time of screening.
18 Years
30 Years
ALL
No
Sponsors
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Imcyse SA
INDUSTRY
Responsible Party
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Principal Investigators
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Pierre Vandepapelière, MD
Role: STUDY_DIRECTOR
Imcyse SA
Christian Boitard, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Cochin, Paris, France
Locations
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Hôpital Erasme
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Bispebjerg and Frederiksberg Hospital
Copenhagen, , Denmark
CHU de Nantes, Hôpital Laennec
Nantes, , France
GWT-TUD GmbH
Dresden, , Germany
Klaipeda University Hospital
Klaipėda, , Lithuania
University Hospital Santaros Klinikos
Vilnius, , Lithuania
Clinical Trial Center, CTC
Gothenburg, , Sweden
ProbarE Stockholm
Stockholm, , Sweden
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Cardiff University
Cardiff, , United Kingdom
Royal Devon and Exeter NHS Trust
Exeter, , United Kingdom
Guy's and St. Thomas NHS Trust
London, , United Kingdom
St. Bartholomew's Hospital (Barts Health NHS Trust)
London, , United Kingdom
Newcastle University
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Registre belge du diabète
Belgisch diabetes register
Research study for people with Type 1 Diabetes: EXALT
Other Identifiers
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IMCY-T1D-001
Identifier Type: -
Identifier Source: org_study_id
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