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

NCT03272269 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

IMCY-0098

Small synthetic peptide for SC admin. Solvent: alum hydroxide

OTHER

Placebo

Solvent: alum hydroxide

Sponsors & Collaborators

  • Imcyse SA

    lead INDUSTRY

Principal Investigators

  • Pierre Vandepapelière, MD · Imcyse SA

  • Christian Boitard, MD · Hôpital Cochin, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2019-04-17
Completion
2019-08-30

Countries

  • Belgium
  • Denmark
  • France
  • Germany
  • Lithuania
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272269 on ClinicalTrials.gov