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NCT05432531 Clinical Trial

Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:
Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05432531
Other study ID # Baracetinib
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2022
Est. completion date April 1, 2023

Study information
Verified date December 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date April 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - lupus nephritis Exclusion Criteria: - cardiac disease Thrombosis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Anti JAK1,2
Induction of remission of active lupus nephritis
• Cyclophosphamid
Induction of remission of active lupus nephritis

Locations
Country Name City State
Egypt Manal Hassanien Assiut Assuit

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Album in urine 24 h protein in urine 6 months
Secondary complement 3 serum level 3 and 6 months
Secondary anti double strand DNA serum level 3 and 6 months
Secondary lupus activity index-2K SLEDAI-2k 3 and 6 months
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