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MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D) (Meld-ATG) Phase 2 114 Biomarker-Driven Double-Blind Placebo-Controlled Academic-Led

Completed
Clinical Trial NCT04509791 (Meld-ATG) was designed to study Treatment for Diabetes Mellitus, Type 1. This was a Phase 2 interventional study that is now completed. The study started on 24 November 2020, with plans to enroll 114 participants. Led by Universitaire Ziekenhuizen KU Leuven, the expected completion date was 16 December 2024. The latest data from ClinicalTrials.gov was last updated on 10 January 2025.
Brief Summary
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluat...Show More
Detailed Description
A phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial.

Randomisation wil be stratified by age. The trial consist of seven cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg and 0.1 mg/kg.

ATG total dose in a 1:1:1:1 allocation ratio. There will be an initial age step down selection of this cohort with recruitm...

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Official Title

MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)

Conditions
Diabetes Mellitus, Type 1
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • Meld-ATG
  • S63466
  • 2019-003265-17 (EudraCT Number)
NCT ID Number
NCT04509791
Start Date (Actual)
2020-11-24
Last Update Posted
2025-01-10
Completion Date (Estimated)
2024-12-16
Enrollment (Estimated)
114
Study Type
Interventional
PHASE
Phase 2
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo Comparatorplacebo
placebo arm
Anti-Human Thymocyte Immunoglobulin, Rabbit
MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
Active Comparator2.5 mg ATG/kg
the trial consists of 7 cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg en 0.1 mg/kg in a 1:1:1:1:1 allocation ratio
Anti-Human Thymocyte Immunoglobulin, Rabbit
MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
Active Comparator1.5 mg ATG/kg
the next two cohorts of 12 participants will be randomised to placebo, 2.5 mg/Kg, and 2 specified middle ATG total doses in a 1:1:1:1 allocation ratio
Anti-Human Thymocyte Immunoglobulin, Rabbit
MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
Active Comparator0.5 mg ATG/kg
The next four cohorts of 15 participants will be randomised to placebo, 2.5 mg/kg and a single selected middle ATG total dose in a 1:1:1 allocation ratio
Anti-Human Thymocyte Immunoglobulin, Rabbit
MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
Active Comparator0.1 mg ATG/kg
the trial consists of 7 cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg en 0.1 mg/kg in a 1:1:1:1:1 allocation ratio
Anti-Human Thymocyte Immunoglobulin, Rabbit
MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
the area under the stimulated C-peptide response curve
over the first 2 hours of a mixed meal tolerance test (MMTT) at 12 months post treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
the area under the stimulated C-peptide response curve
over the first 2 hours of a MMTT at baseline, 3, 6 and 12 months
dry blood spot (DBS) C-peptide measurements
at all observation times
Cluster of differentiation 4 (CD4) positive T cells and Cluster of differentiation 8 (CD8) positive T cells
over 12 months
HbA1c
over 12 months
insulin requirements
The need for insulin (units) on a daily basis
over 12 months
T1D-associated autoantibodies (glutamic acid decarboxylase antibodies (GADA), insulin auto-antibodies (IAA), IA-2 antibodies (IA-2A) and Zinc transporter 8 antibodies (ZnT8A))
The presence of T1D-associated autoantibodies
over 12 months
continuous glucose monitoring (CGM) measurements ( time in range, time above time below)
over 12 months
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
5 Years
Eligible Sexes
All
  • has given written informed consent to participate; or have a parent or legal guardian provide written informed consent. Individual under the age of consent will be asked to assent to trial participation
  • be aged > 5 years to < 25 years at written informed consent/assent
  • have been diagnosed with T1d within 3-9 weeks of planned treatment day 1
  • have random C-peptide levels > 200 pmol/L measured at screening, as tested centrally
  • have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
  • will be > 6 weeks form last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
  • be willing to comply with intensive diabetes management

  • Type 2 diabetes
  • Evidence of prior or current tuberculosis (TB) infection
  • Clinically significant abnormal full blood count (FBC), renal function or liver function at screening
  • Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
  • any active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any additional immunosuppression
  • seropositive for human immunodeficiency virus (HIV),hepatitis B of hepatitis C infection at screening
  • positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) based on local testing regimen
  • unwilling to use appropriate contraception if sexually active during the trial, from date of written informed consent until completion of the 12-month follow-up visit
  • any history of malignancies, other than skin
  • current or ongoing use of non-insulin pharmaceuticals that effect glycaemic control
  • active participation in another T1D treatment interventional trial in the previous 30 days prior to screening ( excluding treatment with insulin)
  • any prior treatment with ATG, Abatacept or Anti-CD3 monoclonal antibody (Anti-CD3)
  • known allergy to ATG or to similar products
  • any condition, complicating medical issues, or abnormal clinical laboratory results that the investigator judges may adversely affect trial conduct, cause increased risk to the participant, or compromise the trial results
Universitaire Ziekenhuizen KU Leuven logoUniversitaire Ziekenhuizen KU Leuven
No contact data.
14 Study Locations in 8 Countries
Medical University of Graz, Graz, Austria
Medical University of Vienna, Vienna, Austria
Universitair Ziekenhuis Antwerpen, Antwerp, Belgium
Universitair ziekenhuis Brussel, Brussels, Belgium
Universite Libre de Bruxelles, Brussels, Belgium
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Herlev University Hospital, Herlev, Denmark
Helsinki University Hospital Children and Adolescents, Helsinki, Finland
Hannoversche Kinderheilanstalt Auf der Bult, Hannover, Germany
IRCCS Ospedale San Raffaele, Milan, Italy
University Medical Centre Ljubljana, Ljubljana, Slovenia

Oxon

Oxford University Hospitals NHS Foundation Trust, Oxford, Oxon, OX3 9DU, United Kingdom
Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom
The Royal London Hospital - Barts Health NHS Trust, London, United Kingdom