drugset / Trial / NCT04008316

Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis

NCT04008316

Phase 3 Unknown 264 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupTriple-blindTreatment

Summary

Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. This molecule inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude.

Timeline

Start
2019-11-12
Primary completion
2022-11-12
Completion
2023-05-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 1 mg Oral