Preventing Diabetes with an Antibody in Relatives at Risk for the Disease

Phase 1

• Conditions: Anti-CD3 mAb is to be used for the prevention of type 1 diabetes mellitus in relatives at risk for developing the disease.; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-002248-98-IT
• Lead Sponsor: TRAILNET COORDINATING CENTER AT THE UNIVERSITY OF SOUTH FLORIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Participant in TrialNet Natural History Study (TN01) and thus a relative of a proband** with T1DM.
2. Between the ages of 1-45 years at the time of enrollment in TN01 and age = 8 at time of randomization in this trial
3. Subject (or parent or legal guardian if the subject is a minor) is willing to provide Informed Consent.
4. Individuals <18 years of age at time of randomization must have had a TrialNet conducted OGTT demonstrating abnormal
glucose tolerance*
within 7 weeks (52 days) of the baseline visit (visit 0).
5. Individuals =18 years of age at time of randomization must have had two consecutive TrialNet conducted OGTT's demonstrating
abnormal
glucose tolerance, the most recent of which must have been within 7 weeks (52 days) of the baseline visit (visit 0).
6. The participant must be positive for two or more diabetes-related autoantibodies on two occasions. The second occasion must
occur within the six months prior to study drug administration, but does not need to involve the same two autoantibodies as were
found on the first occasion.
The autoantibodies that are to be confirmed are anti-GAD65, anti-ICA512, anti-insulin (MIAA), ZnT8 and/or ICA.
7. Weigh at least 26 kg at randomization.
8. If participant is female with reproductive potential, she must have a negative pregnancy test on Day 0 and be willing to avoid
pregnancy for at least one year from randomization.
9. If participant is male, he must be willing to avoid pregnancy in any partners for at least one year from randomization.
10. Willing and medically acceptable to postpone live vaccine immunizations for one year after treatment.
11. Willing to forego other forms of experimental treatment during the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. If =18yo: Diabetes, or have a screening OGTT with:
a. Fasting plasma glucose =126 mg/dL, or
b. 2 hour plasma glucose = 200mg/dL
2. If <18yo: Diabetes, or have a screening random glucose =200mg/dL
3. Lymphopenia (< 1000 lymphocytes/µL).
4. Neutropenia (< 1500 PMN/µL ).
5. Thrombocytopenia (< 150,000 platelets/µL).
6. Anemia (Hgb < 10 grams/deciliter [g/dL]).
7. AST or ALT >1.5 x ULN.
8. Total bilirubin >1.5 x upper limit of normal (ULN) with the exception of subjects with the
diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to
hyperbilirubinemia.
9. INR > 0.1 above the upper limit of normal at the participating center's laboratory.
10. Chronic active infection other than localized skin infections.
11. A positive PPD test.
12. Vaccination with a live virus within 8 weeks of randomization
13. Vaccination with a killed virus within 4 weeks of randomization.
14. A history of infectious mononucleosis within the 3 months prior to enrollment.
15. Laboratory or clinical evidence of acute infection with EBV or CMV.
16. Serological evidence of current or past HIV, Hepatitis B or Hepatitis C infection.
17. Be currently pregnant or lactating, or anticipate getting pregnant.
18. Chronic use of steroids or other immunosuppressive agents.
19. A history of asthma or atopic disease requiring chronic treatment.
20. Untreated hypothyroidism or active Graves' disease at randomization.
21. Current use of non-insulin pharmaceuticals that affect glycemic control.
22. Prior OKT®3 or other anti-CD3 treatment.
23. Administration of a monoclonal antibody within the year before randomization.
24. Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks
before randomization.
25. Any condition that, in the opinion of the investigator, would interfere
with the study conduct or the safety of the subject.

Study & Design

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