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Clinical Trials/EUCTR2020-001317-20-IT
EUCTR2020-001317-20-IT
Active, not recruiting
Phase 1

A Phase Ib/IIa, randomized, double-blind placebo-controlled, multicenter 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 young adult and adolescent patients with a recent onset Type 1 diabetes - IMPACT

Imcyse SA0 sites84 target enrollmentStarted: June 14, 2021Last updated:
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ConditionsType 1 DiabetesMedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Imcyse SA
Enrollment
84
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •(1\)Have given written informed consent for adult participants and adolescent participant's parent(s). Have given written informed assent for adolescent participants.
  • •(2\)Age at screening:
  • •\- Step 1 will include participants aged greater than or equal to 18 years and \< 45 years at the time of consent
  • •\- Step 2 will include participants aged greater than or equal to 12 years and \<45 years at the time of assent/consent.
  • •(3\)Must have a diagnosis of T1D of 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 greater than or equal to 200 pmol/L measured at screening
  • •(6\)Must be HLA DR4 positive
  • •(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.

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. Patients with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is less than or equal to 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\)Has 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)
  • •(4\)Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration
  • •(5\)Require the use of immunosuppressive agents including chronic use of systemic steroids
  • •(6\)Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection

Investigators

Sponsor
Imcyse SA

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