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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272269
• Other study ID #: IMCY-T1D-001
• Status: Completed
• Phase: Phase 1
• Start date: August 23, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2019
• Source: Imcyse SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 30, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Male or female 18 to 30 years of age

2. Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months

3. Insulin requirement, as determined by the investigator

4. Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)

5. Fasting C-peptide at screening >0.2 nmol/L and/or stimulated C-peptide = 0,4 nmol/L.

6. HLADR3-positive and/or HLADR4-positive

7. Willingness to undergo the insulin treatment prescribed by the physician

8. Body mass index (BMI) between 17-28 kg/m2 at screening

9. Fully informed written consent obtained

10. Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.

11. Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.

Exclusion Criteria:

1. Ongoing or planned pregnancy during the whole duration of the study or lactation

2. Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .

3. Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product

4. Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)

5. History of, or current malignancy (except excised basal cell skin cancer)

6. Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study

7. Primary or secondary immune deficiency disorders

8. Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

9. Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale

10. Anti-diabetic treatments other than insulin in the week prior to first study drug administration

11. Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.

12. Treatment with immunotherapy within the past 3 months

13. Treatment with an investigational drug within the past 3 months

14. Patients with a known hypersensitivity to any component of the drug product should be excluded from the study

15. Patients under treatment with statins at the time of screening.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• IMCY-0098
Small synthetic peptide for SC admin. Solvent: alum hydroxide

Other:
• Placebo
Solvent: alum hydroxide

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
Belgium	UZ Brussel	Brussels
Belgium	UZ Gent	Gent
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen
France	CHU de Nantes, Hôpital Laennec	Nantes
Germany	GWT-TUD GmbH	Dresden
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	University Hospital Santaros Klinikos	Vilnius
Sweden	Clinical Trial Center, CTC	Göteborg
Sweden	ProbarE Stockholm	Stockholm
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Cardiff University	Cardiff
United Kingdom	Royal Devon and Exeter NHS Trust	Exeter
United Kingdom	Guy's and St. Thomas NHS Trust	London
United Kingdom	St. Bartholomew's Hospital (Barts Health NHS Trust)	London
United Kingdom	Newcastle University	Newcastle upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Imcyse SA

Countries where clinical trial is conducted

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

References & Publications (3)

Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9. — View Citation

Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015. Review. — View Citation

Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016. Erratum in: Front Immunol. 2018 Jul 09;9:1600. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of T lymphocyte immune response to IMCY-0098	Comparison of changes in IMCY-0098 specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.	up to 24 weeks
Primary	Incidence of all adverse events reported for subjects	Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests	up to 24 weeks
Secondary	Assessment of residual beta cell function and markers of metabolic control	Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups	up to 24 weeks

External Links

•   Belgisch diabetes register
•   Registre belge du diabète
•   Research study for people with Type 1 Diabetes: EXALT
•   Research study for people with Type 1 Diabetes: EXALT
•   Sponsor website