Use of Baricitenib to Maintain of Remission

Sponsor
Assiut University
Study ID
NCT05686746
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Lupus or SLE
  • Nephritis

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Jan 2023
Primary completion
Jun 1, 2023
Completion
Aug 1, 2023

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricetinib 4 mg
    4 mg oral tablet daily
  • Experimental: Baricetinib 2 mg
    2 mg oral tablet daily
  • Active Comparator: MMF
    MMF 500 mg tablet twice daily

Primary Outcome Measure

proteins creatinine ratio [ Time Frame: 3 months ]

Central Contacts

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