Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D)

Phase 1

• Conditions: Type 1 diabetes (T1D); Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2019-003265-17-DK
• Lead Sponsor: niversitair Ziekenhuis Leuven, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-07
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. 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.
2. Be aged =5 years to =25 years at written informed consent/assent
3. Have been diagnosed with T1D within 3–9 weeks of planned treatment day 1
4. Have random C-peptide levels =200 pmol/L measured at screening, as tested centrally
5. Have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
6. Will be =6 weeks from last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
7. Be willing to comply with intensive diabetes management
Are the trial subjects under 18? yes
Number of subjects for this age range: 114
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
1. Type 2 diabetes
2. Evidence of prior or current tuberculosis (TB) infection
3. Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including:
o Immunodeficient or clinically significant chronic leucopenia, neutropenia, lymphopenia or thrombocytopenia at the screening visit, according to local reference ranges
o Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN), at screening
o Evidence of renal dysfunction with creatinine greater than 1.5 times the ULN at screening, adjusted for the age of the patient
o Clinically significant clotting disorder, according to local reference ranges
4. Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
5. 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
6. Seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection at screening
7. Positive for SARS-CoV-2 based on local testing regimen
8. 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
9. Any history of malignancies
10. Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control
11. Active participation in another T1D treatment interventional trial in the previous 30 days prior to screening (excluding treatment with insulin)
12. Any prior treatment with ATG, Abatacept or anti-CD3
13. Known allergy to ATG or to similar products, or hypersensitivity to rabbit proteins or to any of the excipients
14. 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
15. Pregnant and breastfeeding women
16. allergy for rabbit protein

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified