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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03272269
• Date of registration: 29/08/2017
• Prospective Registration: No
• Primary sponsor: Imcyse SA
• Public title: Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
• Scientific 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
• Date of first enrolment: August 23, 2017
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03272269
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

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

Contacts

• Name: Christian Boitard, MD
• Affiliation: Hôpital Cochin, Paris, France

• Name: Pierre Vandepapelière, MD
• Affiliation: Imcyse SA

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Drug: IMCY-0098

Other: Placebo

Primary Outcome(s)

Incidence of all adverse events reported for subjects [Time Frame: up to 24 weeks]

Secondary Outcome(s)

Assessment of residual beta cell function and markers of metabolic control [Time Frame: up to 24 weeks]

Secondary ID(s)

IMCY-T1D-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors