Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis
NCT ID: NCT05432531
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2022-06-01
2023-04-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Baracetinib
oral tablet 4 mg baricitinib and placebo IV infusion/ month
Anti JAK1,2
Induction of remission of active lupus nephritis
Cyclophosphamide
IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily
Cyclophosphamid
Induction of remission of active lupus nephritis
Interventions
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Anti JAK1,2
Induction of remission of active lupus nephritis
Cyclophosphamid
Induction of remission of active lupus nephritis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Manal Hassanien
Associate Professor
Principal Investigators
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Manal M Hassanien, Md
Role: PRINCIPAL_INVESTIGATOR
Associate professor
Locations
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Manal Hassanien
Asyut, Assuit, Egypt
Countries
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Other Identifiers
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Baracetinib
Identifier Type: -
Identifier Source: org_study_id
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