Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2023-06-30
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose-effect Relationship of Low-dose IL-2 in Type 1 Diabetes
NCT01353833
Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist
NCT00303394
Diabetes Islet Preservation Immune Treatment
NCT02586831
Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes
NCT01862120
Low-dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes
NCT02411253
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm
ILT-101 (Aldesleukin; IL-2), 0.5 million IU/m2 (up to a maximum of 1 million IU), or placebo, will be given for 5 consecutive days (days 1-5), and then on day 15 and every 15 days thereafter, for two years.
ILT-101 (Aldesleukin; IL-2)
Administration of Low-Dose Interleukin-2 (ILT-101) for two years
Treatment-Placebo Arm
Participants in this group will receive study drug ILT-101 for one year, and then placebo for the second year.
ILT-101 (Aldesleukin; IL-2)
Administration of Low-Dose Interleukin-2 (ILT-101) for two years
Treatment-Placebo Arm
Administration of Low-Dose Interleukin-2 (ILT-101) for one year, and then placebo for the second year.
Placebo
Participants in this group will receive a placebo injection for two years.
Placebo Arm
Participants in this group will receive a placebo injection for two years.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ILT-101 (Aldesleukin; IL-2)
Administration of Low-Dose Interleukin-2 (ILT-101) for two years
Treatment-Placebo Arm
Administration of Low-Dose Interleukin-2 (ILT-101) for one year, and then placebo for the second year.
Placebo Arm
Participants in this group will receive a placebo injection for two years.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* T1D, demonstrated by at least one islet autoantibody
* T1D duration 4-12 months at the time of the first dose
* Peak stimulated C-peptide \>0.2 nmol/L during a 4-hour MMTT
Exclusion Criteria
* Illnesses that would preclude use of low-dose IL-2
8 Years
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diabetes Research Institute Foundation
OTHER
University of Florida
OTHER
University of California, San Francisco
OTHER
Jay S. Skyler
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jay S. Skyler
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jay S Skyler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine
Alberto Pugliese, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine
David A Baidal, M.D.
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20170301
Identifier Type: OTHER
Identifier Source: secondary_id
20170301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.