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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D).

In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce insulin (islet beta-cells).

The study drug IMCY-0098 is being developed to stop the body's own immune system attacking and destroying the insulin-producing cells. When injected, it will induce new immune cells that will specifically destroy the bad immune cells responsible for the damage to the pancreas.

IMCY-0098 has previously been tested on recently diagnosed type 1 diabetes patients in the first clinical study between 2017 and 2019 to collect information on the safety of IMCY-0098. The next step is to test the best dose and the best number of injections that show the drug can give a benefit. Two doses of IMCY-0098 will be tested and they will be compared to a placebo. Safety information will also be collected during the study for all the participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imcyse SA

Criteria

Inclusion Criteria:

1. Have given written informed consent.

2. Participants aged ≥ 18 years and < 45 years at the time of consent

3. Have a diagnosis of T1D within maximum 9 weeks 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 Human Leukocyte Antigen (HLA) DR4 positive for the main study

• Up to 24 participants with an HLA DR4 negative status but HLA DR3 positive will be eligible for the substudy

7. Be willing to comply with intensive diabetes management

8. Be treated with insulin therapy in accordance with the 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

Exclusion Criteria:

1. Clinically significant abnormal full blood count (FBC), renal function or liver function at screening including

1.1. Be immunodeficient or have any clinically significant chronic lymphopenia:

Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL)

1.2. Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal

1.3. 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. Have received any live attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but is 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 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.