LADARIXIN for New-onset autoimmune Type 1 diabetes | Type 1 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- 1.For adults willingness to provide informed consent. For subjects 14 to 17 years of age provide written assent and have a parent or legal guardian provide informed consent. \n- 2.Diagnosis of T1D based on ADA Criteria\n- 3.A diagnosis of T1D for less than 180 days at randomization\n- 4.Requires, or has required at some time, exogenous insulin between diagnosis and enrollment\n- 5.Test positive for 1 or more diabetes-related autoantibody (GADA, IA-2A, ZnT8A, IAA) measured within 10 days of the start of insulin therapy and confirmed present at screening\n- 6.Be willing to comply with intensive diabetes management (standard of care)\n- 7.Will be ≥6 weeks from last live immunization at planned ATG infusion on day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment\n- 8.Patients <100 days from T1D diagnosis must have a fasting C-peptide at the screening visit >0.2 ng/mL. Patients ≥100 days from T1D diagnosis must have a stimulated C-peptide level (glucagon test) ≥0.6 ng/ml at the screening visit. Furthermore, to be eligible, the C-peptide at time 0’ of the MMTT at baseline must be ≥0.2 ng/ml\n- 9.BMI < 30\n- 10.Baseline HbA1c <10% (86 mmol/mol)"}

Exclusion criteria

• {"criterion_text":"- 1.\tBe currently pregnant (urine pregnancy test) or lactating or anticipate getting pregnant within the study period. Women and men unwilling to use adequate contraception if sexually active during the study\n- 2.\tEvidence of prior or current tuberculous or non-tuberculous mycobacterial infection\n- 3.\tImmunodeficient or clinically significant chronic leucopenia, neutropenia, lymphopenia, or thrombo-cytopenia at the screening visit, according to local reference\n- 4.\tRequiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids\n- 5.\tEvidence of renal dysfunction with creatinine greater than 1.5 times the ULN at screening, adjusted for the age of the patient\n- 6.\tEvidence of liver dysfunction with AST or ALT greater than 3 times ULN, at screening\n- 7.\tClinically significant clotting disorder, according to local reference ranges.\n- 8.\tAny active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any immunosuppression\n- 9.\tHave any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, neurological, or blood count abnormalities\n- 10.\tHave a history of malignancies other than treated skin cancer\n- 11.\tOngoing use of non-insulin pharmaceuticals that affect glycemic control within 7 days prior to screening\n- 12.\tActive participation in another T1D treatment interventional trial in the previous 30 days prior to screening\n- 13.\tAny prior treatment with ATG, Abatacept or anti-CD3 antibodies\n- 14.\tKnown allergy to ATG or to related products, or hypersensitivity to rabbit proteins or to any of the excipients; known hypersensitivity to non-steroidal anti-inflammatory drugs, lactose intolerance\n- 15.\tQTcF > 470 msec; Complete Left Bundle Branch Block (LBBB); atrio-ventricular block (Mobitz II 2nd degree or 2:1 atrio-ventricular block)\n- 16.\tAny psychological or psychiatric conditions that may interfere with study procedures and treatments"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study is the change from baseline in the area under the stimulated C-peptide curve (YAUC) at 2 hour MMTT conducted at the 12 month visit.","definition_or_measurement_approach":"Change from baseline in the area under the stimulated C-peptide curve (YAUC) measured during a 2-hour Mixed Meal Tolerance Test (MMTT) at the 12-month visit."}

Secondary endpoints

• {"endpoint_text":"- Changes in: 1) fasting and stimulated C-peptide 2) HbA1c 3) daily insulin requirements throughout the study 4) time in range (70-180 mg/dl), time in tight range (70-140 mg/dl), time below range (<70 mg/dl), glucose management index by CGM and %CV as measure of glucose variability 5) QoL, patient treatment satisfaction and fear of hypoglycemia will be assessed using the Diabetes-Specific Quality of Life (DSQoL) Questionnaire and the FH-15 Questionnaire, both validated in Italian. 6) a","definition_or_measurement_approach":"Changes measured by fasting and stimulated C-peptide, HbA1c, daily insulin dose requirements, CGM-derived metrics (time in range 70-180 mg/dl, time in tight range 70-140 mg/dl, time below range <70 mg/dl), glucose management index and %CV for variability, and patient-reported outcomes using DSQoL and FH-15 questionnaires; safety via descriptive analysis of AEs/SAEs at 12 months."}

Italy

Earliest CTIS Part Ii Submission Date

10-03-2026

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

30

Number Of Sites

1

Number Of Participants

46

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy