Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

September 4, 2019 updated by: Imcyse SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Hopital Erasme
      • Brussels, Belgium
        • UZ Brussel
      • Gent, Belgium
        • UZ Gent
  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg and Frederiksberg Hospital
  • France
      • Nantes, France
        • CHU de Nantes, Hôpital Laennec
  • Germany
      • Dresden, Germany
        • GWT-TUD GmbH
  • Lithuania
      • Klaipėda, Lithuania
        • Klaipeda University Hospital
      • Vilnius, Lithuania
        • University Hospital Santaros Klinikos
  • Sweden
      • Göteborg, Sweden
        • Clinical Trial Center, CTC
      • Stockholm, Sweden
        • ProbarE Stockholm
  • United Kingdom
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • Cardiff, United Kingdom
        • Cardiff University
      • Exeter, United Kingdom
        • Royal Devon and Exeter NHS Trust
      • London, United Kingdom
        • Guy's and St. Thomas NHS Trust
      • London, United Kingdom
        • St. Bartholomew's Hospital (Barts Health NHS Trust)
      • Newcastle upon Tyne, United Kingdom
        • Newcastle University
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female 18 to 30 years of age
  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:

  1. Ongoing or planned pregnancy during the whole duration of the study or lactation
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1, low dose
4 SC injections of IMCY-0098 or Placebo
Drug: IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Other Names:
  • Imotope
Other: Placebo
Solvent: alum hydroxide
Experimental: Cohort 2, medium dose
4 SC injections of IMCY-0098 or Placebo
Drug: IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Other Names:
  • Imotope
Other: Placebo
Solvent: alum hydroxide
Experimental: Cohort 3, high dose
4 SC injections of IMCY-0098 or Placebo
Drug: IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide
Other Names:
  • Imotope
Other: Placebo
Solvent: alum hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all adverse events reported for subjects
Time Frame: 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
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of residual beta cell function and markers of metabolic control
Time Frame: 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
up to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of T lymphocyte immune response to IMCY-0098
Time Frame: up to 24 weeks
Comparison of changes in IMCY-0098 specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imcyse SA

Investigators

  • Study Director: Pierre Vandepapelière, MD, Imcyse SA
  • Principal Investigator: Christian Boitard, MD, Hôpital Cochin, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2017

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

September 1, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMCY-T1D-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on IMCY-0098

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe