drugset / Trial / NCT05432531

Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

NCT05432531

Phase 3 Unknown 60 enrolled Assiut University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

Timeline

Start
2022-06-01
Primary completion
2022-12-31
Completion
2023-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Baricitinib Small molecule 4 mg Oral
Comparator Cyclophosphamide Other / unclassified 0.7 mg/m2 Intravenous

Indications