Last updated on February 2018

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


Brief description of study

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 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.

Detailed Study Description

Protocol: TRANSREG is a multicentric, uncontrolled, open-label study, comparing biological and clinical responses to the administration of low doses IL2 across 14 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, Gougerot-sjgren, Systemic Sclerosis and Idiopathic Thrombocytopenic Purpura. 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 Piti-Salptrire, Cochin, Saint Antoine, Paul Brousse and Henri Mondor hospitals in Paris and Crteil, France. 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 84 patients and up to 132 patients will be enrolled in this study. Primary efficacy endpoint is the Treg response at Day-8 compared to baseline. Secondary efficacy endpoints are:- evolution of 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.

Clinical Study Identifier: NCT01988506

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Olivier CHAZOUILLERES, MD, PhD

Service d' H pato Gastro Ent rologie - H pital SAINT-ANTOINE
Paris, France
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Laurent BEAUGERIE, MD, PhD

Service de Gastro Ent rologie - H pital SAINT-ANTOINE
Paris, France
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Francis. BERENBAUM, MD, PhD

Service de Rhumatologie - H pital SAINT-ANTOINE
Paris, France
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Nathalie Nicolas, MD

CIC - H pital PITIE SALPETRIERE
Paris, France
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Patrice CACOUB, MD, PhD

Service de M decine Interne - H pital PITIE SALPETRIERE
Paris, France
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Bruno FAUTREL, MD, PhD

Service de Rhumatologie - H pital PITIE SALPETRIERE
Paris, France
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ARACTINGI Selim, MD, PhD

Service de Dermatologie - H pital COCHIN
Paris, France
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Jean-Charles DUCLOS-VALLEE, MD, PhD

Centre H pato-Biliaire - H pital Paul Brousse
Villejuif, France
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Olivier FAIN, MD, PhD

M decine interne - H pital Saint-Antoine
Paris, France
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Emmanuel MESSAS, MD, PhD

Service de m decine vasculaire - HEGP
Paris, France
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Marc MICHEL, MD PhD

Henri Mondor - M decine Interne
Créteil, France
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