Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01988506
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2013-11-07
Brief Title:
Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases a Transnosographic Approach
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSREG
Brief Summary:
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 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 Behcets disease Wegeners granulomatosis Takayasus disease Crohns 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 erythematosuss 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001232-22 | EUDRACT_NUMBER | None | None |