Table 2.
Current trials based on the INNODIA Master Protocol
| Trial reference |
MELD-ATG ClinicalTrials.gov Identifier: NCT04509791 EudraCT 2019-0013265-17 Sponsor: Universitair Ziekenhuis Leuven |
VER-A-T1D ClinicalTrials.gov Identifier: NCT04545151 EudraCT 2010-000435-45 Sponsor: Medical University of Graz |
IMPACT ClinicalTrials.gov Identifier: NCT04524949 EudraCT 2020-001317-20 Sponsor: Imcyse SA |
CFZ33 ISCALIMAB ClinicalTrials.gov Identifier: NCT04129528 EudraCT 2018-004553-25 Sponsor: Novartis Pharma AG |
DiViDint ClinicalTrials.gov Identifier: NCT04838145 EudraCT 2015-003350-41 Sponsor: Division of Paediatric and Adolescent Medicine, Oslo University Hospital |
| Full title | MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D) | A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of Verapamil SR on Preservation of Beta-cell Function (Ver-A-T1D) | 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 | Investigator- and subject-blinded, randomized, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and efficacy of CFZ533 in pediatric and young adults with new-onset type 1 diabetes | The Diabetes Virus Detection and Intervention Trial |
| Treatment arms | 7 cohorts, each recruited sequentially, with between 3 and 5 treatment arms |
2 arms Active drug vs placebo |
3 arms: IMCY-0098, low dose IMCY-0098, high dose Placebo |
2 arms Active drug vs placebo |
2 arms Active drug vs placebo |
| Age group | 5–25 years | 18–45 years | 18–45 years | 6–21 years | 6–15 years |
| Treatment modality | Intravenous infusion for 2 consecutive days | Tablets: once daily (titrated 120 to 360 mg) for 1 year | Subcutaneous injection: 6 times fortnightly; booster dose at 24 weeks | Intravenous for first dose infusion, then home subcutaneous injections for 1 year | Oral solution: once daily for 26 weeks |
| Total duration | 13 months | 13 months | 13 months | 16–36 months | 36 months |