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Clinical Trial Summary

The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04065672
Study type Interventional
Source Peking University People's Hospital
Contact
Status Completed
Phase Phase 2
Start date October 12, 2021
Completion date July 28, 2023

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