Back to resultsEfficiency of Use of Baracetinib in Treatment of Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Anti JAK1,2
Cyclophosphamid
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
Inclusion Criteria:
- lupus nephritis
Exclusion Criteria:
- cardiac disease Thrombosis
Sites / Locations
- Manal Hassanien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Baracetinib
Cyclophosphamide
Arm Description
oral tablet 4 mg baricitinib and placebo IV infusion/ month
IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily
Outcomes
Primary Outcome Measures
Album in urine
24 h protein in urine
Secondary Outcome Measures
complement 3
serum level
anti double strand DNA
serum level
lupus activity index-2K
SLEDAI-2k
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05432531
Brief Title
Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis
Official Title
Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
patient and outcome assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baracetinib
Arm Type
Experimental
Arm Description
oral tablet 4 mg baricitinib and placebo IV infusion/ month
Arm Title
Cyclophosphamide
Arm Type
Active Comparator
Arm Description
IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily
Intervention Type
Drug
Intervention Name(s)
Anti JAK1,2
Other Intervention Name(s)
Baritava
Intervention Description
Induction of remission of active lupus nephritis
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamid
Other Intervention Name(s)
Indoxan
Intervention Description
Induction of remission of active lupus nephritis
Primary Outcome Measure Information:
Title
Album in urine
Description
24 h protein in urine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
complement 3
Description
serum level
Time Frame
3 and 6 months
Title
anti double strand DNA
Description
serum level
Time Frame
3 and 6 months
Title
lupus activity index-2K
Description
SLEDAI-2k
Time Frame
3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lupus nephritis
Exclusion Criteria:
cardiac disease Thrombosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal M Hassanien, Md
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After completing the study and published
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Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis
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