INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Dunger, David B.; Bruggraber, Sylvaine F. A.; Mander, Adrian P.; Marcovecchio, M. Loredana; Tree, Timothy; Chmura, Piotr Jaroslaw; Knip, Mikael; Schulte, Anke M.; Mathieu, Chantal

doi:10.1186/s13063-022-06259-z

Table 2 Current trials based on the INNODIA Master Protocol

From: INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

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

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