Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03243058 |
Other study ID # |
20170301 |
Secondary ID |
20170301 |
Status |
Withdrawn |
Phase |
Phase 1/Phase 2
|
First received |
|
Last updated |
|
Start date |
June 2023 |
Est. completion date |
December 2028 |
Study information
Verified date |
November 2023 |
Source |
University of Miami |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate
the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can
prevent further loss of beta-cell function in patients with established T1D, (primary
outcome). The study will carefully examine various effects of low-dose IL-2 on the immune
system in patients with T1D, including effects on Treg and other cell subsets, and
disease-specific autoimmune responses.
Description:
Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate
the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can
prevent further loss of beta-cell function in patients with established T1D, (primary
outcome). The study will carefully examine various effects of low-dose IL-2 on the immune
system in patients with T1D, including effects on Treg and other cell subsets, and
disease-specific autoimmune responses.
Patients will be treated with ILT-101 or placebo. ILT-101 will be given at doses of 0.5
million IU (body surface area <2 m2) or 1 million IU (body surface area >2 m2), via
subcutaneous (s.c.) injections. Patients will receive a course of 5 daily injections (days
1-5. Starting on day 15, patients will receive an s.c. injection (same dose) every 15 days
for 1 year. Thus, patients will receive 29 injections during the first year of treatment. At
the end of the first year, approximately half of those randomized to ILT-101 will continue
receiving treatment every 15 days, until the end of the second year (23 doses). The other
half will stop therapy and will be switched to a placebo.
A group of patients will be randomly assigned to a placebo for the duration of the study.
Patients to be included in this study are those diagnosed with T1D who would have had T1D
from 4 months to 1 year at the time of randomization, who have a current or past
demonstration of autoimmunity (using autoantibodies), and maintain preserved β-cell function,
defined as an MMTT stimulated C-peptide >0.2 nmol/L. This population is chosen because it
will extend the scope of therapy beyond the immediate time following diagnosis when most
previous studies of immunotherapy in T1D have been conducted. This trial can further impact
the field if a therapeutic benefit is shown when the disease is more established.