TRANSREG is a multicentric, uncontrolled, open-label study, comparing biological and clinical responses to the administration of low dose of IL-2 across 11 selected pathologies (12 patients/pathology): rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematous, psoriasis, Behçet's disease, Wegener's granulomatosis, Takayasu's disease, Crohn's disease, ulcerative colitis, autoimmune hepatitis, and sclerosing cholangitis. TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in the above mentionned pathologies 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.
- Percentage of Tregs at Day8 compared to baseline (Day0)
- Changes in Treg percentage at Day 15, 29, 85, 183 and 240 compared to baseline (Day0)
- Changes in levels of inflammation markers
(CRP, CRP ulta sensible, PCT, Albumin, LDH, anemia)
- Number of relapses
- Change in the clinical global impression severity and efficacy scale (CGI-sev and scale, CGI-effscales) at Day 85, 183 and 240 compared to baseline (Day1)
- Change in the quality of life (EuroQL-5 scale)
- Evolution of clinical, biological or radiological criteria specific to each disease
- Safety Assessment all along the observation period (Day-1 to Day-240). This 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 months after IL2- treatment stop.