Status:
COMPLETED
Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
Lead Sponsor:
Imcyse SA
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief 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 o...
Eligibility Criteria
Inclusion
- Male or female 18 to 30 years of age
- Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
- Insulin requirement, as determined by the investigator
- Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
- Fasting C-peptide at screening \>0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
- HLADR3-positive and/or HLADR4-positive
- Willingness to undergo the insulin treatment prescribed by the physician
- Body mass index (BMI) between 17-28 kg/m2 at screening
- Fully informed written consent obtained
- Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.
- Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.
Exclusion
- Ongoing or planned pregnancy during the whole duration of the study or lactation
- 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 .
- 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
- 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)
- History of, or current malignancy (except excised basal cell skin cancer)
- Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
- Primary or secondary immune deficiency disorders
- Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
- Anti-diabetic treatments other than insulin in the week prior to first study drug administration
- Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
- Treatment with immunotherapy within the past 3 months
- Treatment with an investigational drug within the past 3 months
- Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
- Patients under treatment with statins at the time of screening.
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03272269
Start Date
August 23 2017
End Date
August 30 2019
Last Update
September 6 2019
Active Locations (17)
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1
Hôpital Erasme
Brussels, Belgium
2
UZ Brussel
Brussels, Belgium
3
UZ Gent
Ghent, Belgium
4
Bispebjerg and Frederiksberg Hospital
Copenhagen, Denmark