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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
A Phase IIa, Randomized, Double-blind, Dose Comparison, Placebo-controlled, Multi-centre Clinical Trial to Evaluate the Immune Signature of the Treatment With the Imotope IMCY-0098 and Its Effect on the Preservation of Beta-cell Function in Adult Patients With a Recent Onset Type 1 Diabetes

Clinical Trial 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.

Clinical Trial Description

The main study will include 84 HLA DR4+ patients. In addition, up to 24 HLA DR4-/DR3+ patients will be included in a mechanistic substudy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04524949
Study type Interventional
Source Imcyse SA
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 29, 2020
Completion date January 2025
View Details
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