A Phase 2 interventional study of Interleukin 2 in Rheumatoid Arthritis, Ankylosing Spondylitis and Systemic Lupus Erythematosus, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
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-sjögren, 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 Pitié-Salpêtrière, Cochin, Saint Antoine, Paul Brousse and Henri Mondor hospitals in Paris and Créteil, 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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 81 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
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
Percentages of Tregs
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)
Time frame: Day8
Percentages of Tregs
Changes in Treg percentage at Day 15, 29, 85, 183, 240, 360 and 540 compared to baseline (Day0)
Time frame: Day 15, 29, 85, 183, 240, 360 and 540
inflammation markers (CRP and CRP ultra sensible)
Changes in levels of inflammation markers
Time frame: Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540
markers of inflammatory anemia (Hemoglobin, serum iron level, transferrin) ferritin
Changes in levels of inflammation markers
Time frame: Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540
Number of relapses
Time frame: up to Day540
CGI-sev, CGI-activity and CGI-eff scales
Change in the clinical global impression severity and efficacy scale (CGI-sev, CGI-act and CGI-eff scales) at Day 85, 183, 240, 360 and 540 compared to baseline (Day1)
Time frame: Day 85, 183, 240, 360 and 540
EuroQL-5 scale
Change in the quality of life (EuroQL-5 scale)
Time frame: Day 183
Evolution of clinical, biological or radiological criteria specific to each disease
Changes in disease-specific score and/or evolution of clinical, biological or radiological criteria specific to each disease
Time frame: up to Day 540
Safety Assessment
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 up to 1 year after IL2- treatment stop.
Time frame: up to Day 540
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris