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

NCT03243058 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 20170301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes; Type 1 Diabetes; Autoimmune; Diabetes, Autoimmune; Interleukin-2; Interleukin; IL-2

Outcome Measures

Primary Outcomes (1)

• C-peptide response

  Preservation of insulin secretion (measured as c-peptide nmol/L) based on stimulated area under the curve (AUC) during a 4-hour MMTT at 1 year

  1 year primary outcome

Secondary Outcomes (1)

• C-peptide response

  2 year secondary outcome

Other Outcomes (3)

• Proportions of regulatory T cells at (a) 1 year, (b) 2 years

  1 Year and 2 Years

• Changes in insulin requirements

  1 Year and 2 Years

• HbA1c level

  1 Year and 2 Years

Study Arms (3)

Treatment Arm

ACTIVE COMPARATOR

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.

Biological: ILT-101 (Aldesleukin; IL-2)

Treatment-Placebo Arm

EXPERIMENTAL

Participants in this group will receive study drug ILT-101 for one year, and then placebo for the second year.

Biological: ILT-101 (Aldesleukin; IL-2); Other: Treatment-Placebo Arm

Placebo

PLACEBO COMPARATOR

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

Other: Placebo Arm

Interventions

ILT-101 (Aldesleukin; IL-2) BIOLOGICAL

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

Also known as: IL-2, Interleukin-2

Treatment Arm; Treatment-Placebo Arm

Treatment-Placebo Arm OTHER

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

Treatment-Placebo Arm

Placebo Arm OTHER

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

Placebo

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• 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

You may not qualify if:

• Treatment with oral anti-diabetic agents
• Illnesses that would preclude use of low-dose IL-2

Sponsors & Collaborators

• Jay S. Skyler: lead
• Diabetes Research Institute Foundation: collaborator
• University of Florida: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

aldesleukin; Interleukin-2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Jay S Skyler, M.D.

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

• Alberto Pugliese, M.D.

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

• David A Baidal, M.D.

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomization will be performed by the Coordinating Center at the University of Miami. The participants will not be informed regarding the intervention assignment until the end of the study. The investigators and clinic personnel will also be masked as to study assignment. Laboratories performing assays for this protocol will be masked as to the identity and group assignment of biological materials to be studied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: ILT-101 (aldesleukin; Interleukin-2, IL-2), 0.5 million IU (body surface area \<2 m2) or 1 million IU (body surface area \>2 m2), or placebo, will be given for 5 consecutive days (days 1-5), and then on day 15 and every 15 days thereafter, for one year; at the one-year endpoint, approximately half the subjects on ILT-101 will continue therapy and the other half will switch to placebo for 1 more year.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 8, 2017
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)