Low-dose IL-2 Treatment on Behcet's Disease

Status Completed

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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05635266` - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed	`NCT02190916` - Vasculitis Illness Perception (VIP) Study	N/A
Recruiting	`NCT02593565` - Vasculitis Pregnancy Registry
Completed	`NCT00167583` - Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB)	Phase 3
Completed	`NCT03371095` - Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease	Phase 3
Completed	`NCT01960790` - Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
Completed	`NCT03531385` - Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease
Completed	`NCT02190942` - VCRC Patient Contact Registry Patient-Reported Data Validation Study
Completed	`NCT04328064` - The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease	N/A
Not yet recruiting	`NCT06285539` - Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases	Phase 2
Completed	`NCT02190929` - Educational Needs of Patients With Systemic Vasculitis	N/A
Completed	`NCT02476292` - Impact of Vasculitis on Employment and Income	N/A
Completed	`NCT03543709` - Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease
Recruiting	`NCT01793168` - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed	`NCT01988506` - Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases	Phase 2
Recruiting	`NCT01952275` - Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases	N/A
Completed	`NCT01532570` - Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions	Phase 3
Completed	`NCT03410290` - Journey of Patients With Vasculitis From First Symptom to Diagnosis
Completed	`NCT02176070` - Reproductive Health in Men and Women With Vasculitis	N/A
Recruiting	`NCT01306955` - The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease	Phase 4