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Low-dose IL-2 in Established T1D - The "PROREG" Study

NCT03243058 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes
  • Diabetes, Autoimmune

Interventions

BIOLOGICAL

ILT-101 (Aldesleukin; IL-2)

Administration of Low-Dose Interleukin-2 (ILT-101) for two years

OTHER

Treatment-Placebo Arm

Administration of Low-Dose Interleukin-2 (ILT-101) for one year, and then placebo for the second year.

OTHER

Placebo Arm

Participants in this group will receive a placebo injection for two years.

Sponsors & Collaborators

Principal Investigators

  • Jay S Skyler, M.D. · Professor of Medicine

  • Alberto Pugliese, M.D. · Professor of Medicine

  • David A Baidal, M.D. · Assistant Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243058 on ClinicalTrials.gov