Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

Assiut University

Status and phase: Active, not recruiting; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: Anti JAK1,2; Drug: Cyclophosphamid

Study type: Interventional

Funder types: Other

Identifiers

NCT05432531

Baracetinib

Details and patient eligibility

About

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.

Full description

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.

The baricitinib 4 mg dose suggestive to significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the idea for future trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• lupus nephritis

Exclusion criteria

• cardiac disease Thrombosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Baracetinib

Experimental group

Description:

oral tablet 4 mg baricitinib and placebo IV infusion/ month

Treatment:

Drug: Anti JAK1,2

Cyclophosphamide

Active Comparator group

Description:

IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily

Treatment:

Drug: Cyclophosphamid