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

Prior treatment

• Evidence of prior or current tuberculosis (TB) infection
• Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
• 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)

Other illness

• Type 2 diabetes
• 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
• any history of malignancies, other than skin
• known allergy to ATG or to similar products

Lab values

• Clinically significant abnormal full blood count (FBC), renal function or liver function at screening
• 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

Other

• 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
• current or ongoing use of non-insulin pharmaceuticals that effect glycaemic control

• 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