NCT04190693: IMCY-T1D-002

IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo

Completed Phase 1 Results posted Last updated 2 May 2022

What this trial tests

Phase 1 trial testing IMCY-0098 or placebo in Type 1 Diabetes Mellitus in 30 participants. Completed in 18 November 2019.

Timeline

14 February 2019

Primary endpoint
8 October 2019

18 November 2019

Quick facts

Lead sponsor	Imcyse SA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	30
Start date	14 February 2019
Primary completion	8 October 2019
Estimated completion	18 November 2019
Sites	19 locations across Denmark, France, Belgium, Sweden, United Kingdom, Germany, Lithuania

Drugs / interventions tested

• IMCY-0098 or placebo — full drug profile →

Conditions studied

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

Sponsor

Imcyse SA — full company profile →

Who can join

Adults 18 to 31, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adverse Events Primary · Throughout the study period (24weeks)

Group	Value	95% CI
Cohort 1	5
Cohort 2	6
Cohort 3	10
Placebo	4

Serious Adverse Events Primary · Throughout the study period (24 weeks)

Group	Value	95% CI
Cohort 1	0
Cohort 2	0
Cohort 3	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Throughout the study period (24 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1

Serious: 0/4 (0%)

Deaths: 0/4

Cohort 2

Serious: 0/7 (0%)

Deaths: 0/7

Cohort 3

Serious: 0/12 (0%)

Deaths: 0/12

Placebo

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (19 terms — click to expand)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Placebo
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Foreign body in eye	Injury, poisoning and procedural complications	—	—	—	—
Sports injury	Injury, poisoning and procedural complications	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—
Adbominal pain upper	Gastrointestinal disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Genital rash	Reproductive system and breast disorders	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Bacterial infection	Infections and infestations	—	—	—	—
Fungal ski infection	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT04190693 adverse events section.

Sponsor's own description

This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in which patients with recent onset T1D have been treated with IMCY-0098 or placebo.

At the end of the primary 6 month study, patients will be proposed to enter this follow-up study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the clinical parameters.

The study involves a follow-up of 6 months after the end of the initial participation to the IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post first study product administration in study IMCY-T1D-001.

For each patient, the study comprises a total of 3 visits occurring over a period of approximately 24 weeks (from study entry). The patients will undergo planned assessments and procedures as outlined in the table of study procedures.

Publications & conference data

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

1. 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
2. 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
3. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5