The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.
The investigators designed a single center, Phase 2, randomised, double-blind, placebo-controlled, parallel-group, superiority design study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines. After a 4-week screening period, patients were randomly assigned in a 1:1 ratio to receive IL-2 at a dose of 1 million IU or placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study. After 12 weeks placebo-controlled treatment period, a 12-week observational followed up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
After a 4-week screening period, patients received IL-2 at a dose of 1 million IU subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up.
After a 4-week screening period, patients received placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up.
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, China
the number of oral ulcers at week 12
the number of oral ulcers at week 12
Time frame: Week 12
the change in pain from oral ulcers from baseline to week 12
measured on a 100-mm visual-analogue scale (with 0 representing nopain and 100 the worst pain ever experienced),and the change in disease activity from baselineto week 12.
Time frame: Week 12 and Week 24
Change from baseline in the Behçet's Syndrome Activity Score
a scaleon which scores range from 0 to 100, with higherscores indicating more active disease
Time frame: Week 12 and Week 24
Change from baseline in simplified Behcet Disease Current Activity Form (BDCAF) Score
cores range from 0 to 12, withhigher scores indicating more active disease
Time frame: Week 12 and Week 24
Change from baseline in Protocol-specific immunophenotypic analysis of peripheral blood lymphocyte subsets
Relative proportions of Treg, Tfh, Th1, Th2 and Th17 cell subsets were analyzed by flow cytometetry usingFACSAria III (BD) and FlowJo software (Tree Star). Treg cells were defined as CD3+ CD4+ CD25high CD127low, Tfh cells as CD3+ CD4+ CXCR5+ PD1high CCR7low6, Th1 cells as CD3+ CD4+ CXCR3+ CCR6- CCR4- CCR7low, Th2 cells as CD3+ CD4+ CXCR3+ CCR6- CCR4+ CCR7low and Th17 cells as CD3+ CD4+ CXCR3- CCR6+ CCR4+ CCR7low26.
Time frame: Week 12 and Week 24
the number of genital ulcers at week 12 and Week 24
the number of genital ulcers at week 12 and Week 24
Time frame: Week 12 and Week 24
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the proportion of patients with a complete response to oral ulcers
the proportion of patients who had no oral ulcers at week 12
Time frame: Week 12
the percentage of patients with genital ulcers at baseline who were ulcer-free at week 12
the percentage of patients with genital ulcers at baseline who were ulcer-free at week 12
Time frame: Week 12