Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

Phase 3

Active, not recruiting

• Conditions: Lupus Nephritis
• Interventions: Drug: Anti JAK1,2; Drug: Cyclophosphamid

• Registration Number: NCT05432531
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-27
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Primary Completion: 2022-12-31
• Last Update Posted: 2023-01-04
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• lupus nephritis

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Exclusion Criteria

• cardiac disease Thrombosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baracetinib	Anti JAK1,2	oral tablet 4 mg baricitinib and placebo IV infusion/ month
Cyclophosphamide	Cyclophosphamid	IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily

Primary Outcome Measures

Name	Time	Method
Album in urine	6 months	24 h protein in urine

Secondary Outcome Measures

Name	Time	Method
lupus activity index-2K	3 and 6 months	SLEDAI-2k
anti double strand DNA	3 and 6 months	serum level
complement 3	3 and 6 months	serum level

Trial Locations

Locations (1)

Manal Hassanien; 🇪🇬 Assiut, Assuit, Egypt