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IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study)

NCT04524949 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-06-24

No results posted yet for this study

Summary

The IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D).

In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce insulin (islet beta-cells).

The study drug IMCY-0098 is being developed to stop the body's own immune system attacking and destroying the insulin-producing cells. When injected, it will induce new immune cells that will specifically destroy the bad immune cells responsible for the damage to the pancreas.

IMCY-0098 has previously been tested on recently diagnosed type 1 diabetes patients in the first clinical study between 2017 and 2019 to collect information on the safety of IMCY-0098. The next step is to test the best dose and the best number of injections that show the drug can give a benefit. Two doses of IMCY-0098 will be tested and they will be compared to a placebo. Safety information will also be collected during the study for all the participants.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

IMCY-0098 450 μg

Small synthetic peptide for SC admin. Solvent: alum hydroxide

DRUG

IMCY-0098 1350 μg

Small synthetic peptide for SC admin. Solvent: alum hydroxide

DRUG

Placebo

Solvent: alum hydroxide

Sponsors & Collaborators

  • Imcyse SA

    lead INDUSTRY

Principal Investigators

  • Jean Van Rampelbergh · Imcyse SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2024-01-26
Completion
2024-05-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Italy
  • Lithuania
  • Slovenia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04524949 on ClinicalTrials.gov