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Trial record 1 of 2 for:    imcyse
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Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

This study is currently recruiting participants.
Verified November 2017 by Imcyse SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT03272269
First Posted: September 4, 2017
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Imcyse SA
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: IMCY-0098 Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind, placebo controlled
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Imcyse SA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 40
Actual Study Start Date: August 23, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Imotope
Other: Placebo
Solvent: alum hydroxide

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272269


Contacts
Contact: Pierre Vandepapelière, MD 0032 4 366 47 63 p.vandepapeliere@imcyse.com
Contact: Jean Van Rampelbergh, PhD j.vanrampelbergh@imcyse.com

Locations
Belgium
Hôpital Erasme Recruiting
Brussels, Belgium
UZ Brussel Recruiting
Brussels, Belgium
UZ Gent Recruiting
Gent, Belgium
Denmark
Bispebjerg and Frederiksberg Hospital Recruiting
Copenhagen, Denmark
France
CHU de Nantes, Hôpital Laennec Not yet recruiting
Nantes, France
Hôpital Cochin Not yet recruiting
Paris, France
Hôpital Saint-Louis Not yet recruiting
Paris, France
Germany
GWT-TUD GmbH Not yet recruiting
Dresden, Germany
Universitätsklinikum Freiburg Not yet recruiting
Freiburg, Germany
Justus-Liebig-Universität Gießen Not yet recruiting
Gießen, Germany
Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH) Not yet recruiting
München, Germany
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Cardiff University Recruiting
Cardiff, United Kingdom
Royal Devon and Exeter NHS Trust Not yet recruiting
Exeter, United Kingdom
Guy's and St. Thomas NHS Trust Not yet recruiting
London, United Kingdom
St. Bartholomew's Hospital (Barts Health NHS Trust) Not yet recruiting
London, United Kingdom
Newcastle University Not yet recruiting
Newcastle upon Tyne, United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
Imcyse SA
Investigators
Study Director: Pierre Vandepapelière, MD Imcyse SA
Principal Investigator: Christian Boitard, MD Hôpital Cochin, Paris, France
  More Information

Additional Information:
Publications:
Responsible Party: Imcyse SA
ClinicalTrials.gov Identifier: NCT03272269     History of Changes
Other Study ID Numbers: IMCY-T1D-001
First Submitted: August 29, 2017
First Posted: September 4, 2017
Last Update Posted: November 10, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imcyse SA:
Diabetes Mellitus type 1
Autoimmune disease
Immunotherapy
Diabetes treatment
Residual beta cell function
Adult patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases