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

• Research type

  Research Study

• Full title

  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

• IRAS ID

  285844

• Contact name

  Jean Van Rampelbergh

• Contact email

  j.vanrampelbergh@imcyse.com

• Sponsor organisation

  Imcyse SA

• Eudract number

  2020-001317-20

• Clinicaltrials.gov Identifier

  NCT04524949

• Duration of Study in the UK

  2 years, 8 months, 1 days

• Research summary

  This is a Phase Ib/IIa randomised, double-blind, multi-centre, adaptive design study, comparing IMCY-0098 and placebo in adult and adolescent participants with recent onset Type I diabetes (T1D). This study is designed to be conducted in two steps: Step 1 will include 24 patients aged 18-45 who will be randomised 1:1:1 to treatment with 450 µg IMCY-0098 or 1350 µg IMCY-0098 or placebo, at 2-weekly intervals, for 6 treatments.
  
  Step 2 will include 60 participants in two sub-groups (patients aged 12-17 and those aged 18-45). These patients will be randomised 1:1:1 to receive either: A) IMCY-0098 regimen with IMCY-0098 boost or B) IMCY-0098 regimen with PLACEBO boost or C) Placebo regimen with placebo boost. During the treatment period / regimen, study drug or placebo will be given at 2-weekly intervals for a maximum of 6 administrations. All boosts will be given at 24 weeks. The number of treatments and the dose of IMCY-0098 to be used will be confirmed following the outcome of step 1 of the study and prior to implementation of the second step of study.
  
  Step 1 patients will undergo 10 study visits, including screening and randomisation visits, over a period of approximately 52 weeks. Step 2 participants will have an additional study visit to receive a "boost" treatment (placebo or IMCY-0098) 24 weeks after the initial treatment and will therefore undergo 11 study visits over a period of approximately 52 weeks.

  The purpose of this study is to explore the best dose and number of administrations (i.e. the best treatment regimen) and to confirm that the study drug is effective when used in the best regimen. This study aims to evaluate the effect of IMCY-0098 on the immune signature (treatment-specific biomarkers) and the effect of the study drug upon the preservation of beta-cell function in adolescents and young adult patients with Type 1 Diabetes. Further safety data will also be collected.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  20/WM/0220

• Date of REC Opinion

  11 Sep 2020

• REC opinion

  Further Information Favourable Opinion