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Low-dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes

NCT02411253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2023-08-14

No results posted yet for this study

Summary

Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells, leading to an absolute deficiency in insulin.

In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and likewise prevent autoimmune diseases. Tregs are insufficient in T1D.

The investigators previously showed that administration of low doses of IL-2 induces selective expansion and activation of Tregs in mice and humans.

The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could block the ongoing autoimmune destruction of insulin producing cells in patients with recently diagnosed T1D.

Conditions

Interventions

DRUG

rhIL-2

Subcutaneous injections of IL2 according to regimen A Subcutaneous injections of IL2 according to regimen B

DRUG

Placebo

Subcutaneous injections of Placebo according to regimen A Subcutaneous injections of Placebo according to regimen B

Sponsors & Collaborators

  • Iltoo Pharma

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • David Klatzmann, MD, Ph.D. · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2020-11-30
Completion
2022-11-30

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02411253 on ClinicalTrials.gov