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Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases (TRANSREG)

  Purpose

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 12 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

Condition Intervention Phase
Rheumatoid Arthritis Ankylosing Spondylitis Systemic Lupus Erythematosus Psoriasis Behcet’s Disease Wegener’s Granulomatosis Takayasu’s Disease Crohn’s Disease Ulcerative Colitis Autoimmune Hepatitis Sclerosing Cholangitis Gougerot-sjögren Drug: Interleukin 2 Phase 2

Study Type: Interventional
Study Design:Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

Resource links provided by NLM:

Further study details as provided by Assistance Publique – Hôpitaux de Paris:

Primary Outcome Measures:

  • Percentages of Tregs [ Time Frame: Day8 ]
    Change in Treg percentage (percentages of Tregs within the CD4+ lymphocytes) at Day-8 after administration of low-dose of IL2 compared to baseline (Day0)

Secondary Outcome Measures:

  • Percentages of Tregs [ Time Frame: Day 15, 29, 85, 183, 240, 360 and 540 ]
    Changes in Treg percentage at Day 15, 29, 85, 183, 240, 360 and 540 compared to baseline (Day0)

  • CRP, CRP ulta sensible, PCT, Albumin, LDH, anemia [ Time Frame: Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540 ]
    Changes in levels of inflammation markers

  • Number of relapses [ Time Frame: up to Day540 ]
  • CGI-sev and CGI-eff scales [ Time Frame: Day 85, 183, 240, 360 and 540 ]
    Change in the clinical global impression severity and efficacy scale (CGI-sev and scale, CGI-eff scales) at Day 85, 183, 240, 360 and 540 compared to baseline (Day1)

  • EuroQL-5 scale [ Time Frame: Day 183 ]
    Change in the quality of life (EuroQL-5 scale)

  • Evolution of clinical, biological or radiological criteria specific to each disease [ Time Frame: up to Day 540 ]
    Changes in disease-specific score and/or evolution of clinical, biological or radiological criteria specific to each disease

  • Safety Assessment [ Time Frame: up to Day 540 ]
    Safety Assessment all along the observation period (Day-1 to Day-240): Safety assessment will include vital signs, adverse events and concomitant medications collection as well as biology during the 6 months of the treatment period; .In addition, the evolution of the disease will be followed 2,5 months after IL2- treatment stop.

Estimated Enrollment:132
Study Start Date:January 2014
Estimated Study Completion Date:August 2018
Estimated Primary Completion Date:January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interleukin 2

Interleukin 2, 1MUI.= Proleukin®, RhIL-2
Drug: Interleukin 2

Induction period: repeated administration of low-dose IL-2 (1MUI/day, sc) during 5 consecutive days.Maintenance period: treatment with IL-2, 1MUI once every 15 days (except systemic lupus erythematosus’s patients every 7 days) for 6 months

Detailed Description:

Protocol: TRANSREG is a multicentric, uncontrolled, open-label study, comparing biological and clinical responses to the administration of low doses IL2 across 12 selected pathologies: rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Behcet’s disease, Wegener’s granulomatosis, Takayasu’s disease, Crohn’s disease, ulcerative colitis, autoimmune hepatitis, sclerosing cholangitis and Gougerot-sjögren. Methods: Each patient will receive 1MUI /day of IL2 from Day-1 to Day-5 (the induction period), and then every 2 weeks (except systemic lupus erythematosus’s patients will received every week) from Day-15 to Day-180 (the maintenance period). Patients will thereafter be followed up for 12 months (Day-181-Day-540). For each pathology, 6 patients will be included at Pitié-Salpêtrière, Cochin, Saint Antoine and Paul Brousse hospitals in Paris. An interim analysis will be performed in each pathology group when the first six patients have received at least 3 months of treatment. In those pathology groups in which a Treg response will be documented, six additional patients will be included. In total, a minimum of 72 patients and up to 132 patients will be enrolled in this study. Primary efficacy endpoint is the Treg response at Day-8. Secondary endpoints are:- the Treg response during the maintenance period,- the changes in markers of inflammation – the clinical response, evaluated by means of global generic scales [Clinical Global Impression severity scale (CGI-sev) and Clinical Global Impression efficacy index (CGI-eff)] as well as specific clinical and biological evaluations for each disease, – the frequency of relapses, – the assessment of quality of life (scale EuroQL-5).Expected Results: TRANSREG will define which patients respond to IL2, whether per pathology or according to pre-treatment phenomics, allowing to guide further clinical development of low dose IL2 in autoimmune and auto-inflammatory diseases.

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