Use of Baricitenib to Maintain of Remission

Assiut University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Lupus or SLE; Nephritis

Treatments: Drug: Baricitinib 2 MG; Drug: MMF; Drug: Baricitinib 4 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05686746

systemic lupus

Details and patient eligibility

About

Baricitinib a selective Janus kinase (JAK) inhibitors 1&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date.

Full description

Baricitinib a selective Janus kinase (JAK) inhibitors 1&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date. Objectives: To assess the efficacy and safety of Baricitinib in patients (pts) with LN by dose 4mg versus 2 mg versus MMF 1 gm daily dose.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Lupus nephritis Disease
• Must be able to swallow tablets
• lupus nephritis in remission

Exclusion criteria

• antiphospholipid syndrome disease
• thrombosis history
• sever anemia, leukopenia or thrombocytopenia
• impaired liver and renal function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 3 patient groups

Baricetinib 4 mg

Experimental group

Description:

4 mg oral tablet daily

Treatment:

Drug: Baricitinib 4 MG

Baricetinib 2 mg

Experimental group

Description:

2 mg oral tablet daily

Treatment:

Drug: Baricitinib 2 MG

MMF

Active Comparator group

Description:

MMF 500 mg tablet twice daily

Treatment:

Drug: MMF