A Phase IIa, randomized, double-blind placebo-controlled, dose comparison, multi-centre adaptive design 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

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Description

Subcutaneous injections of IMCY-0098 or placebo every 2 weeks, for a total of 7 injections

Details
Age

Adult

Eligibility

Ages 18-44 Within 9 weeks from first insulin dose Positive for at least 1 type 1 diabetes autoanitibody Measurable remaining c-peptide Up to date on vaccinations

Participants aged ≥ 18 years and < 45 years at the time of consent Have a diagnosis of T1D within maximum 9 weeks at screening (date of the first insulin injection) Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8) Must have random C-peptide levels ≥ 200 pmol/L measured at screening Must be Human Leukocyte Antigen (HLA) DR4 positive to participate in the main study Be treated with insulin therapy in accordance with the local standard of care Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment. 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 Have HbA1c levels ≤ 9.5% prior to randomization Exclusion Criteria: 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 1.2. Evidence of renal dysfunction with serum creatinine greater than 1.5 times the upper limit of normal OR (US ONLY) estimated Glomerular Filtration Rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) <90 mL/min per 1.73 m2 in absence of other signs of CKD or rapidly progressing renal disease 1.3. Evidence of liver dysfunction. Patients for which a liver disease would be diagnosed will be excluded from the study. Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry Have signs or symptoms of active COVID infection or a positive COVID PCR test during the screening period Have received any live attenuated vaccine within 3 months prior to the first planned administration of the study product Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration Require the use of immunosuppressive agents including chronic use of systemic steroids. Topical, inhalational or intranasal corticosteroids are allowed Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection 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 History of, or current malignancy (except excised basal cell skin cancer) Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within 7 days prior to screening visit Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days or (US ONLY) received gene therapy in the past Known hypersensitivity to any component of the drug product CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study Be diagnosed with Latent Autoimmune Diabetes in Adults (LADA) (US ONLY) History or current evidence of hematologic condition that would make HbA1c uninterpretable Current evidence of hypertension defined as the mean (average) of Diastolic Blood Pressure (DBP) > 89 mm Hg or Systolic Blood Pressure (SBP) > 129 mm Hg based on 3 consecutive readings at least 2 minutes apart History or current evidence of active drug, chemical or alcohol dependency.

Type of Study

Treatment

Locations

Barbara Davis Center
University of Colorado Hospital

Principal Investigator
Photograph of Peter Gottlieb,  MD

Peter Gottlieb, MD

Study ID

Protocol Number: 22-0478

More information available at ClinicalTrials.gov: NCT04524949

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