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

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ClinicalTrials.gov Identifier: NCT03272269
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Imcyse SA

Tracking Information
First Submitted Date  ICMJE August 29, 2017
First Posted Date  ICMJE September 5, 2017
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE August 23, 2017
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 1, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind, placebo controlled
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: IMCY-0098
    Small synthetic peptide for SC admin. Solvent: alum hydroxide
    Other Name: Imotope
  • Other: Placebo
    Solvent: alum hydroxide
Study Arms  ICMJE
  • Experimental: Cohort 1, low dose
    4 SC injections of IMCY-0098 or Placebo
    Interventions:
    • Drug: IMCY-0098
    • Other: Placebo
  • Experimental: Cohort 2, medium dose
    4 SC injections of IMCY-0098 or Placebo
    Interventions:
    • Drug: IMCY-0098
    • Other: Placebo
  • Experimental: Cohort 3, high dose
    4 SC injections of IMCY-0098 or Placebo
    Interventions:
    • Drug: IMCY-0098
    • Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2017)
40
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Germany,   Lithuania,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03272269
Other Study ID Numbers  ICMJE IMCY-T1D-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imcyse SA
Study Sponsor  ICMJE Imcyse SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pierre Vandepapelière, MD Imcyse SA
Principal Investigator: Christian Boitard, MD Hôpital Cochin, Paris, France
PRS Account Imcyse SA
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP