Use of Baricitenib to Maintain of Remission

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05686746
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lupus or SLE; Nephritis	Drug: Baricitinib 4 MG; Drug: Baricitinib 2 MG; Drug: MMF	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: participant and investigator and outcome assessor
• Primary Purpose: Treatment
• Official Title: Uses of Baricetinib 4 mg or 2mg Versus MMF to Maintain Lupus Remission Randomized Controlled Trial: Outcomes Over 2 Years
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Baricetinib 4 mg 4 mg oral tablet daily	Drug: Baricitinib 4 MG; 4 mg oral daily
Experimental: Baricetinib 2 mg 2 mg oral tablet daily	Drug: Baricitinib 2 MG; 2 mg oral daily
Active Comparator: MMF MMF 500 mg tablet twice daily	Drug: MMF; 1000 mg oral daily

Outcome Measures

Primary Outcome Measures

1. proteins creatinine ratio [3 months]

   nephritis

2. proteins creatinine ratio [6 months]

   nephritis

3. proteins creatinine ratio [1 year]

   nephritis

Secondary Outcome Measures

1. complement 3 [3 months]

   serum level

2. complement 3 [6 months]

   serum level

3. complement 3 [1 year]

   serum level

4. anti ds DNA [3 months]

   serum level

5. anti ds DNA [6 months]

   serum level

6. anti ds DNA [1 year]

   serum level

7. ANA [3 months]

   serum level

8. ANA [6 months]

   serum level

9. ANA [1 year]

   serum level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manal Hassanien	Assiut	Yes	Egypt	7111

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Manal Hassanien, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manal Hassanien, Associate Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT05686746
• Other Study ID Numbers: systemic lupus
• First Posted: Jan 17, 2023
• Last Update Posted: Jan 17, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nephritis

Study Results

No Results Posted as of Jan 17, 2023