Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
- Registration Number
- NCT03272269
- Lead Sponsor
- Imcyse SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1, low dose IMCY-0098 4 SC injections of IMCY-0098 or Placebo Cohort 2, medium dose Placebo 4 SC injections of IMCY-0098 or Placebo Cohort 2, medium dose IMCY-0098 4 SC injections of IMCY-0098 or Placebo Cohort 1, low dose Placebo 4 SC injections of IMCY-0098 or Placebo Cohort 3, high dose Placebo 4 SC injections of IMCY-0098 or Placebo Cohort 3, high dose IMCY-0098 4 SC injections of IMCY-0098 or Placebo
- Primary Outcome Measures
Name Time Method Incidence of all adverse events reported for subjects up to 24 weeks 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
- Secondary Outcome Measures
Name Time Method Assessment of residual beta cell function and markers of metabolic control up to 24 weeks Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups
Trial Locations
- Locations (17)
Hôpital Erasme
🇧🇪Brussels, Belgium
CHU de Nantes, Hôpital Laennec
🇫🇷Nantes, France
ProbarE Stockholm
🇸🇪Stockholm, Sweden
Clinical Trial Center, CTC
🇸🇪Göteborg, Sweden
GWT-TUD GmbH
🇩🇪Dresden, Germany
Guy's and St. Thomas NHS Trust
🇬🇧London, United Kingdom
Royal Devon and Exeter NHS Trust
🇬🇧Exeter, United Kingdom
Cardiff University
🇬🇧Cardiff, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
St. Bartholomew's Hospital (Barts Health NHS Trust)
🇬🇧London, United Kingdom
UZ Brussel
🇧🇪Brussels, Belgium
UZ Gent
🇧🇪Gent, Belgium
Klaipeda University Hospital
🇱🇹Klaipėda, Lithuania
University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
Bispebjerg and Frederiksberg Hospital
🇩🇰Copenhagen, Denmark
Newcastle University
🇬🇧Newcastle upon Tyne, United Kingdom