Type 1 Diabetes MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Imcyse SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Have given written informed consent. (2) Participants aged =18 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks for the two doses of IMCY-0098 versus placebo. ;Secondary Objective: (1) To determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 12 and 24 weeks and to month 18 and month 24 for two doses of IMCY-0098 (2) To determine the difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups from baseline to 48 weeks for the two doses of IMCY-0098. (3) To determine the changes in DBS C-peptide measurements until visit 11 comparing each dose with placebo. (4) To determine the effects of each dose of IMCY-0098 on HbA1c, hypoglycaemic events, Diabetes Ketoacidosis episodes, daily total insulin dose and CGM measures. (5)To evaluate the impact of IMCY-0098 at each dose on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time. (6)To evaluate the safety features of IMCY-0098 at both doses. ;Primary end point(s): The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at baseline and 48 weeks in the IMCY-0098 groups compared to placebo. ;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at baseline, at 12 and 24 weeks and at month 18 and month 24 in the IMCY-0098 groups compared to placebo (2) The DBS C-peptide measurements from baseline to 48 weeks (3) The DBS C-peptide responses at each visit until visit 11 (4) 4.1.Change in HbA1c, from baseline to 24 and 48 weeks and to 18 and 24 months 4.2.Number of treatment-emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA) 4.3.Number of treatment-emergent episodes of diabetic ketoacidosis (DKA) 4.4.Change in insulin requirements, baseline to 24 and 48 weeks and to 18 and 24 months as the daily total dose (three days average) in units per kg body weight (BW) 4.5.Continuous glucose monitoring (CGM) time in range (70-180 mg/dL, 3.9-10.0 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range (<70 mg/dL, < 3.9 mmol/L) during 10 days at 12, 24 and 48 weeks and to 18 and 24 months compared to the reference period (first 10 days after randomization) (5) Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 24 and 48 weeks and to 18 and 24 months (6) 6.1 Occurrence, intensity and relationship of any listed injection site and systemic AEs during a 7-day follow-up period (i.e., day of study product administration and 6 subsequent days) after each IMCY-0098 or placebo dose 6.2 Occurrence, intensity and relationship of any unlisted injection site and AEs throughout the study period 6.3 Occurrence and relationship of all SAEs throughout the study period 6.4 Occurrence and relationship of any abnormality in physical examination, vital signs, 12-lead ECG 6.5 Measure of CD4+/CD8+ lymphocytes ratio;Timepoint(s) of evaluation of this end point: (1) MMTT: D0, w12, w24, w48, M18, M24 (2) The DBS C | — |
Countries
Belgium, Italy, Lithuania, Slovenia, United Kingdom
Contacts
Public ContactJean Van Ramperlbergh
Imcyse SA
Outcome results
None listed