NCT04524949: IMPACT

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

Terminated Phase 2 Last updated 24 June 2024

What this trial tests

Phase 2 trial testing IMCY-0098 450 μg in Diabetes Mellitus, Type 1 in 110 participants. Terminated before completion.

Timeline

29 December 2020

Primary endpoint
26 January 2024

29 May 2024

Quick facts

Lead sponsor	Imcyse SA
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	110
Start date	29 December 2020
Primary completion	26 January 2024
Estimated completion	29 May 2024
Sites	29 locations across Italy, Belgium, Sweden, United Kingdom, Lithuania, Australia, Slovenia, United States

Drugs / interventions tested

• IMCY-0098 450 μg — full drug profile →
• IMCY-0098 1350 μg — full drug profile →
• Placebo

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Imcyse SA — full company profile →

Who can join

Adults 18 to 44, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes.
   Dunger DB, Bruggraber SFA, Mander AP, Marcovecchio ML, et al · · 2022 · cited 28× · PMID 35585600 · DOI 10.1186/s13063-022-06259-z
2. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes.
   Van Rampelbergh J, Achenbach P, Leslie RD, Ali MA, et al · · 2023 · cited 16× · PMID 37226224 · DOI 10.1186/s12916-023-02900-z
3. Delivery route considerations for designing antigen-specific biomaterial strategies to combat autoimmunity.
   Ackun-Farmmer MA, Jewell CM. · · 2023 · cited 15× · PMID 36938103 · DOI 10.1002/anbr.202200135
4. Epitope-based precision immunotherapy of Type 1 diabetes.
   Firdessa Fite R, Bechi Genzano C, Mallone R, Creusot RJ. · · 2023 · cited 10× · PMID 36656048 · DOI 10.1080/21645515.2022.2154098
5. Antigen-specific immunotherapy to restore antigen-specific tolerance in Type 1 diabetes and Graves' disease.
   Zala A, Thomas R. · · 2023 · cited 10× · PMID 36545825 · DOI 10.1093/cei/uxac115
6. Monitoring islet specific immune responses in type 1 diabetes clinical immunotherapy trials.
   Arif S, Domingo-Vila C, Pollock E, Christakou E, et al · · 2023 · cited 6× · PMID 37283770 · DOI 10.3389/fimmu.2023.1183909
7. Emerging Concepts and Success Stories in Type 1 Diabetes Research: A Road Map for a Bright Future.
   Mallone R, Sims E, Achenbach P, Mathieu C, et al · · 2025 · cited 3× · PMID 39446565 · DOI 10.2337/db24-0439
8. Autoimmune Type 1 Diabetes: An Early Approach Appraisal for Spain by the AGORA Diabetes Collaborative Group.
   Gómez-Peralta F, Pinés-Corrales PJ, Santos E, Cuesta M, et al · · 2025 · cited 1× · PMID 39860426 · DOI 10.3390/jcm14020418