IMCY-0098 Proof of ACtion in Type 1 Diabetes - IMPACT Study

Phase 1

Conditions: Type 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]

Registration Number: EUCTR2020-001317-20-SI

Lead Sponsor: Imcyse SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

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:
- Barrier contraception (condom and spermicide) or
- True abstinence (where this is in accordance with the participants preferred and usual lifestyle)
(10) All females must have a negative serum pregnancy test at screening. Women sexually active and of childbearing potential must agree to use a highly effective contraception method from screening up to 90 days after last treatment with the investigational product.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
(8) Presence of any uncontrolled disease (including uncontrolled autoimmune disease) or abnormal clinical laboratory results that may interfere with study conduct as judged by the investigator.
(9) History of, or current malignancy (except excised basal cell skin cancer).
(10) Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within the 7 days prior to screening visit.
(11) Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days.
(12) Known hypersensitivity to any component of the drug product.
(13) CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study.
(14) Be diagnosed with Latent Autoimmune Diabtes in Adults (LADA)