A Phase IIa, randomized, double-blind, dose comparison placebo-controlled, multi-centre clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect on the preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes

Imcyse SA0 sites84 target enrollmentAugust 3, 2020

ConditionsType 1 Diabetes MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Imcyse SA
Enrollment: 84
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 3, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Imcyse SA

Eligibility Criteria

Inclusion Criteria

•(1\) Have given written informed consent.
•(2\) Participants aged \=18 years and \< 45 years at the time of consent.
•(3\) Must have a diagnosis of T1D within maximum 9 weeks duration at screening (date of the first insulin injection).
•(4\) Must have at least one or more diabetes\-related autoantibodies present at screening (GAD65, IA\-2, or ZnT8\).
•(5\) Must have random C\-peptide levels \=200 pmol/L measured at screening.
•(6\) Must be HLA DR4 positive for the main study.
•a. Up to 24 participants with an HLA DR4 negative status but HLA DR3 positive will be eligible for the sub\-study.
•(7\) Must be willing to comply with intensive diabetes management.
•(8\) Be treated with insulin therapy in accordance with local standard of care.
•(9\) Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment. This includes:

Exclusion Criteria

•(1\) Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including
•a.Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\< 3,000 leukocytes /µL), neutropenia (\<1,500 neutrophils/µL), lymphopenia (\<800 lymphocytes/µL), or thrombocytopenia (\<100,000 platelets/µL).
•b.Evidence of renal dysfunction with creatinine greater than 1\.5 times the upper limit of normal.
•c.Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal. Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is \= 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis.
•(2\) Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry.
•(3\) Have signs or symptoms of active COVID infection or a positive COVID PCR test during the screening period.
•(4\) Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but not limited to: 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\) Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration.
•(6\) Require the use of immunosuppressive agents including chronic use of systemic steroids. Topical, inhalational or intranasal corticosteroids are allowed.
•(7\) Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.