Use of Baricitenib to Maintain of Remission
Primary Purpose
Lupus or SLE, Nephritis
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Baricitinib 4 MG
Baricitinib 2 MG
MMF
Sponsored by
About this trial
This is an interventional treatment trial for Lupus or SLE
Eligibility Criteria
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
Sites / Locations
- Manal HassanienRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Baricetinib 4 mg
Baricetinib 2 mg
MMF
Arm Description
4 mg oral tablet daily
2 mg oral tablet daily
MMF 500 mg tablet twice daily
Outcomes
Primary Outcome Measures
proteins creatinine ratio
nephritis
proteins creatinine ratio
nephritis
proteins creatinine ratio
nephritis
Secondary Outcome Measures
complement 3
serum level
complement 3
serum level
complement 3
serum level
anti ds DNA
serum level
anti ds DNA
serum level
anti ds DNA
serum level
ANA
serum level
ANA
serum level
ANA
serum level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05686746
Brief Title
Use of Baricitenib to Maintain of Remission
Official Title
Uses of Baricetinib 4 mg or 2mg Versus MMF to Maintain Lupus Remission Randomized Controlled Trial: Outcomes Over 2 Years
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
August 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus or SLE, Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
participant and investigator and outcome assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baricetinib 4 mg
Arm Type
Experimental
Arm Description
4 mg oral tablet daily
Arm Title
Baricetinib 2 mg
Arm Type
Experimental
Arm Description
2 mg oral tablet daily
Arm Title
MMF
Arm Type
Active Comparator
Arm Description
MMF 500 mg tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Baricitinib 4 MG
Intervention Description
4 mg oral daily
Intervention Type
Drug
Intervention Name(s)
Baricitinib 2 MG
Intervention Description
2 mg oral daily
Intervention Type
Drug
Intervention Name(s)
MMF
Intervention Description
1000 mg oral daily
Primary Outcome Measure Information:
Title
proteins creatinine ratio
Description
nephritis
Time Frame
3 months
Title
proteins creatinine ratio
Description
nephritis
Time Frame
6 months
Title
proteins creatinine ratio
Description
nephritis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
complement 3
Description
serum level
Time Frame
3 months
Title
complement 3
Description
serum level
Time Frame
6 months
Title
complement 3
Description
serum level
Time Frame
1 year
Title
anti ds DNA
Description
serum level
Time Frame
3 months
Title
anti ds DNA
Description
serum level
Time Frame
6 months
Title
anti ds DNA
Description
serum level
Time Frame
1 year
Title
ANA
Description
serum level
Time Frame
3 months
Title
ANA
Description
serum level
Time Frame
6 months
Title
ANA
Description
serum level
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Hassanien, MD
Phone
00201062679200
Email
manal_hassanien@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
State/Province
Yes
ZIP/Postal Code
7111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal M Hassanien, MD
Phone
+201062679200
Email
manal_hassanien@yahoo.com
First Name & Middle Initial & Last Name & Degree
Manal Hassanien
Phone
+201062679200
Email
manal_hassanien@yahoo.com
First Name & Middle Initial & Last Name & Degree
Helal Hetta, MD
First Name & Middle Initial & Last Name & Degree
Sonya Rashad, Prof
First Name & Middle Initial & Last Name & Degree
Abdelhafeez Moshrif
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
after finishing study
Learn more about this trial
Use of Baricitenib to Maintain of Remission
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