ANTI-T LYMPHOCYTE IMMUNOGLOBULIN FOR HUMAN USE, RABBIT for Type 1 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- from the beginning of Screening to Visit 14."}

Exclusion criteria

• {"criterion_text":"- 1.\tHistory of recurrent (e.g., several times a year) of severe (e.g., pneumonia) or chronic infections or conditions predisposing to chronic infections"}
• {"criterion_text":"- 2.\tHistory of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy"}
• {"criterion_text":"- 3.\tVaccination within 4 weeks before randomization"}
• {"criterion_text":"- 4.\tPositive Viral PCR for EBV, CMV, COVID"}
• {"criterion_text":"- 5.\tPatients with HIV or HTLV I/II infection or HepB/C"}
• {"criterion_text":"- 6.\tReceipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening"}
• {"criterion_text":"- 7.\tHistory of pancreatitis (acute or chronic)"}
• {"criterion_text":"- 8.\tAny past or current diagnosis of malignant neoplasms"}
• {"criterion_text":"- 9.\tKnown impairment of the immune system, except for T1D, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease or well-balanced Hashimoto’s disease), and vitiligo"}
• {"criterion_text":"- 10.\tPatients with a psychiatric condition (e.g., severe anxiety, psychosis) that would interfere with the study as determined by the primary investigator. Stable psychiatric conditions such as chronic anxiety or depression will be allowed."}
• {"criterion_text":"- 11.\tPatients with known allergy to one or more of the study drug components or rabbit proteins."}
• {"criterion_text":"- 12.\tFemale patients who are pregnant, lactating, or who want to get pregnant during the study period."}
• {"criterion_text":"- 13.\tPatients with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol but excluding nicotine and caffeine)."}
• {"criterion_text":"- 14.\tPatients with any other significant chronic disease, according to the investigator discretion, exclude rare forms of diabetes (MODY) according to history and clinical judgement."}
• {"criterion_text":"- 15.\tObesity (BMI more than 35 kg/m2)"}
• {"criterion_text":"- 16.\tOther forms of diabetes"}
• {"criterion_text":"- 17.\tPatients unable or unwilling to comply with the protocol"}

Primary endpoints

• {"endpoint_text":"- AUC0-2h for a mixed meal tolerance test (MMTT) stimulated C-peptide concentration-time curve (C-peptideAUC) at 12 months relative to baseline","definition_or_measurement_approach":"Measured as AUC0-2h of the MMTT-stimulated C‑peptide concentration-time curve at 12 months compared to baseline (mixed meal tolerance test)."}

Secondary endpoints

• {"endpoint_text":"- Peak MMTT stimulated C-peptide concentration (C-peptidemax) at months 6, 12 and 24 relative to baseline Change in fasting C-peptide from baseline to months 6 and 12 Change in HbA1c from baseline to month 12 HbA1c at 12 and 24 months Change in fasting plasma glucose from baseline to month 12 Total insulin treatment administered over the period of 12 months calculated as AUC (insulinAUC). Total daily insulin dose per kg at 1, 3, 6 and 12 months Percentage of patients that maintain stimulated pea","definition_or_measurement_approach":"Includes peak MMTT-stimulated C-peptide (C-peptidemax) at months 6, 12, 24; changes in fasting C-peptide at months 6 and 12; change in HbA1c at month 12 and HbA1c at 12 and 24 months; change in fasting plasma glucose at month 12; total insulin administered over 12 months calculated as insulin AUC; total daily insulin dose per kg at 1, 3, 6, 12 months; percentage of patients maintaining stimulated ... (text truncated in source). Measurements based on MMTT, laboratory assays and routine clinical measures."}

Czechia

Earliest CTIS Part Ii Submission Date

05-10-2023

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

944

Number Of Sites

2

Number Of Participants

18

Primary sponsor

Full Name

Institute For Clinical And Experimental Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"Czechia","full_name":"Institute of Clinical and Experimental Medicine (IKEM), Prague, CZ","duties_or_roles":"Source of monetary support / funding","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Czechia","full_name":"University Hospital of Kralovske Vinohrady (FNKV)","duties_or_roles":"Source of monetary support / funding","organisation_type":"Educational Institution / Hospital"}

Co-sponsors

• University Hospital Kralovske Vinohrady